[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"obesity-amp-overweight\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:obesity-amp-overweight":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,46,76,103,134,162,186,212,235,260,283,306,326,349,376,406,432,454,479,500,521,547,570,593,620],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100609746","sanctuary-farm-prescription-in-adolescents-100609746",false,"NCT07218588","Sanctuary Farm Prescription in Adolescents","Inclusion\n\n1. Patients seen at Nemours TJU Primary Care Clinic\n2. Ages 12-17 years at enrollment\n3. BMI \\> or = 85th percentile\n4. English Speaking\n5. Willing to provide parental permission and ability to provide child assent for the study\n\nExclusion\n\n1. Children with neurocognitive delays that would limit participation or ability to assent\n2. Use of G-tube\u002FJ-tube\n3. Food allergies that in the opinion of the investigators would interfere with ability to participate.","ALL","12 Years","17 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this research study is to learn if an 8-week produce prescription program (in partnership with a local urban farm) can increase fruit and vegetable consumption in overweight teens and improve their blood pressure and weight. The main questions are:\n\n* Is a produce prescription program in overweight teens feasible?\n* Will a produce prescription with educational videos increase weekly fruit and vegetable intake?\n* Will a produce prescription with educational videos improve blood pressure and weight for height?\n\nResearchers will compare the teens' fruit and vegetable intake, blood pressure and weight for height before and after the produce prescription. Researchers will also see how feasible it is by measuring the number of produce prescriptions are picked up by the families and how many educational videos are viewed.\n\nParticipants will:\n\n* complete questionnaires related to their diet and nutrition\n* measure their blood pressure and weight at the beginning and end of the study\n* obtain weekly produce prescriptions",[26,27],"Obesity &Amp; Overweight","Adolescence",[29,30,31,32],"adolescence","obesity","overweight","diet","RECRUITING","2026-05-04",{"date":36,"type":37},"2026-05-08","ACTUAL",{"date":39,"type":37},"2025-11-20",{"date":41,"type":20},"2026-07-31",{"name":43,"class":44},"Nemours Children's Clinic","OTHER",3,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100610738","effects-of-grape-consumption-on-the-immune-gut-axis-in-obesity-100610738","NCT07231484","Effects of Grape Consumption on the Immune-Gut Axis in Obesity","Effects of Grape Consumption on Immune and Gut Health in the Setting of Obesity","Inclusion Criteria:\n\n* Age: 30-45 years\n* Obesity with BMI of 30-45 kg\u002Fm2\n* Willingness to consume study foods\n* Consistent diet and activity patterns for 4 weeks\n* Weight stable (\\\u003C5kg change over last 3 months)\n* Non-smoker \\> 1 year or more\n* Not currently consuming an extremely healthy diet\n\nExclusion Criteria:\n\n* Study food allergies\n* Regular consumption of grapes or grape-derived products\n* Gastrointestinal disease and\u002For bariatric surgery\n* Uncontrolled hypertension and blood pressure \\>180\u002F110\n* Diabetes\n* Clinical Depression\n* Illicit drug use\n* History of alcohol or drug abuse\n* Recent use of medications that affect immune function (e.g., corticosteroids)\n* Recent consumption of antibiotics, prebiotics, probiotics, symbiotics, or dietary supplements containing fiber or phytochemicals\n* Pregnant or lactating individuals\n* HIV positivity\n* Recent start of medications that affect metabolism or appetite\n* Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia","30 Years","45 Years",{"count":19,"type":20},[23],"This study is investigating the benefits of whole freeze-dried grape powder consumption on the immune-gut axis in adults with obesity.",[26],[60,61,62,63,64,65],"Obesity","Immunity","Microbiome","Gut","Grape","Stress","2025-12-22",{"date":68,"type":37},"2025-12-30",{"date":70,"type":37},"2025-12-19",{"date":72,"type":20},"2027-12-30",{"name":74,"class":44},"University of Missouri-Columbia",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":15,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":75},"100598781","training-app-for-inhibitory-control-towards-food-100598781","NCT07075952","Training App for Inhibitory Control Towards Food","Testing FoodTraining (FoodT): A Mobile App to Train Inhibitory Control Towards Food and Augment Standard Treatment for People With Eating and Weight Disorders","FoodT-RCT","Inclusion Criteria:\n\n* BMI in the obesity range (\\>30) or a clinician-formulated diagnosis of binge eating disorder or bulimia nervosa;\n* knowledge of Italian or English;\n* access to a mobile device (e.g. smartphone, tablet).\n\nExclusion Criteria:\n\n* visual impairment not corrected by glasses\n* a diagnosis of psychosis;\n* intellectual disability.","16 Years",{"count":86,"type":20},113,[23],"The aim of this project is to test the feasibility, acceptability and clinical impact of a mobile app-based intervention (FoodTraining) to strengthen food-related inhibitory control over 4 weeks, in a sample of people with eating or weight disorders (i.e. obesity, binge-eating disorder (BED), or bulimia nervosa (BN)) receiving standard outpatient treatment (i.e., treatment as usual (TAU) encompassing guided self-help or psychotherapy, pharmacological therapy or diet). The training will be offered in addition to TAU (experimental group) and compared to TAU alone (control group).\n\nParticipants will complete questionnaires to measure eating behaviour, eating disorder psychopathology, symptoms of anxiety, depression and stress, social functioning and quality of life at baseline, 4 and 8 weeks. They will also complete momentary assessments using a mobile application (FoodTracker) to report on food intake along with related thoughts, emotions, and behaviours and will wear small, non-invasive sensors to track real-time fluctuations in glucose levels for 15 days.\n\nParticipants will also perform a food-related go-no go task and a food-related temporal discounting task at baseline, 4 and 8 weeks.\n\nFinally, this study will pilot the use of a semi-structured interview to characterise the history of weight, the appetite system, eating-related habits in the family and learning of eating behaviours and attitudes in people with eating or weight disorders.",[26,90,91],"Bulimia Nervosa","Binge-Eating Disorder",[93,94,95,90,91,60],"App","Training","Inhibitory control",{"date":68,"type":37},{"date":98,"type":37},"2025-10-01",{"date":100,"type":20},"2027-03",{"name":102,"class":44},"University of Padova",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":115,"conditions":116,"keywords":121,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":4},"100617123","phase-2-evaluating-the-impact-of-glp-1-receptor-agonists-with-total-neoadjuvant-therapy-in-rectal-cancer-100617123","NCT07314528","Evaluating the Impact of GLP-1 Receptor Agonists With Total Neoadjuvant Therapy in Rectal Cancer","A Phase II Multi-institutional Randomized Trial Evaluating the Impact of GLP-1 Receptor Agonists in Combination With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Written informed consent according to local guidelines obtained prior to any study-related activities.\n* Histologically confirmed mismatch repair protein proficient adenocarcinoma of the rectum.\n* BMI ≥25 kg\u002Fm²\n* Radiological confirmed \\>T2, Node positive, Threatened Surgical Margin and\u002For EMVI+ by MRI\n* Imaging available for radiomics analysis\n* Absence of metastatic disease at registration.\n* Adequate renal function is defined as calculated creatinine clearance (CrCl) \\>50ml\u002Fmin.\n* ANC \\> 1.5 cells\u002Fmm3, HGB \\> 8.0 gm\u002Fdl, PLT \\> 150,000\u002Fmm3, total bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's Syndrome who must have total bilirubin ≤ 3.0 x ULN), AST≤ 3 x ULN, ALT ≤ 3 x ULN\n* Able to tolerate medication.\n* ECOG 0-2\n\nExclusion Criteria:\n\n* Received prior chemotherapy or radiotherapy\n* Previous or concurrent active malignancy ≤ 5 years prior to registration, with the exception of non-melanotic skin cancer or carcinoma in situ of any type, or other cancers that the treating investigator does not feel will impact the study objectives.\n* Locally advanced disease T3N+ or T4 disease.\n* Recurrent rectal cancer\n* Metastatic disease at presentation\n* Patients unable to undergo MRI\n* Patients having already received weight-loss intervention (pharmacological or surgical)","18 Years",{"count":112,"type":20},42,[114],"PHASE2","The goal of this clinical trial is to see if adding a weight loss medication (GLP-1 receptor drug) to patients with an increased BMI receiving treatment for rectal cancer prior to surgery (total neoadjuvant chemoradiotherapy) improves cancer outcomes. The main questions it aims to answer is\n\n1. Does the drug increase weight loss in rectal cancer patients with a high BMI\n2. Does the drug improve response rates to chemotherapy and radiotherapy\n3. Does the drug improve survival outcomes and if cancer returns\n\nResearchers will compare this drug in one group against a group of patients receiving preoperative total neoadjuvant chemoradiotherapy without the drug\n\nPatients will be required to\n\n1\\) take the GLP-1 receptor agonist drug during TNT or just having TNT alone as per standard hospital protocols\n\nBody weight will be measured at three predefined time points:\n\n1. Baseline: Prior to initiation of semaglutide or TNT\n2. Pre-TNT: Start of TNT (for the intervention arm, this is 4 weeks after semaglutide initiation)\n3. Post-TNT: Within 7 days following completion of TNT and prior to definitive surgery\n\nPatients will complete their treatment and go on to have surgery as per standard methods for treating rectal cancer",[117,26,118,119,120],"Rectal Cancer Patients","Locally Advanced Rectal Cancer (LARC)","Total Neoadjuvant Therapy","GLP-1",[122,119,123],"Locally Advanced Rectal Cancer","GLP-1 Receptor Agonist","NOT_YET_RECRUITING","2025-12-17",{"date":127,"type":37},"2026-01-02",{"date":129,"type":20},"2026-04",{"date":131,"type":20},"2028-09",{"name":133,"class":44},"St. James's Hospital, Ireland",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":143,"conditions":144,"keywords":148,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":75},"100615802","a-prospective-randomnised-controlled-trial-comparing-overall-patient-compliance-in-a-bariatric-surgical-pathway-using-the-standard-versus-a-more-intensified-and-interactive-version-of-the-get-ready-smartphone-application-100615802","NCT07297342","A Prospective Randomnised Controlled Trial Comparing Overall Patient Compliance in a Bariatric Surgical Pathway Using the Standard Versus a More Intensified and Interactive Version of the \"Get Ready\" Smartphone Application.","Inclusion Criteria:\n\n* Patients undergoing bariatric surgery\n\nExclusion Criteria:\n\n* Previous bariatric surgery",{"count":141,"type":20},200,[23],"The aim of this study is to assess the impact of a newly intensified digital platform following bariatric surgery. This will be measured using several questionnaires. The following objectives will be evaluated: the exact amount of weight loss achieved preoperatively with the preparatory diet; the occurrence of dumping symptoms; the assessment of quality of life (QOL); and compliance with supplement intake.\n\nBy examining the impact of an enhanced digital platform, we aim to address critical questions regarding the effectiveness of improved patient support in the digital domain. Moreover, given the increasing prevalence of bariatric surgery as a therapeutic option for obesity, it is of utmost importance to identify strategies to optimize patient education and support through digital tools. This study not only contributes to the scientific understanding of digital support in bariatric care but also has important implications for the further development of the \"Get Ready\" application, ensuring that it remains at the forefront of providing comprehensive and patient-centered support in the evolving landscape of bariatric surgery.",[26,145,146,147],"Hypertension","Obstructive Sleep Apnea (OSAS)","Diabetes Mellitus ( Type 1 and Type 2)",[149,150,151,152],"Get Ready","application","bariatric","compliance","2025-12-16",{"date":66,"type":37},{"date":156,"type":37},"2025-04-02",{"date":158,"type":20},"2027-06",{"name":160,"class":161},"Sint Dimpna Ziekenhuis Geel","NETWORK",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":21,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":75},"100603270","phase-2-ubt251-injection-phase-ii-clinical-study-ckd-100603270","NCT07134335","UBT251 Injection Phase II Clinical Study (CKD)","A Phase II Clinical Study to Evaluate the Efficacy and Safety of UBT251 Injection in Obese\u002FOverweight Chronic Kidney Disease (CKD) Population","Inclusion Criteria:\n\n1. Age 18\\~75 years old (including border value), BMI \\>=24 kg\u002Fm\\^2, gender is not limited.\n2. Subject estimated glomerular filtration rate (eGFR): \\>=45 and \\\u003C 90 mL\u002Fmin\u002F1.73m\\^2 (calculated using the CKD-EPI formula).\n3. Subjects 300 mg\u002Fg \\\u003C= UACR \\\u003C= 5000 mg\u002Fg 3 months or more prior to screening; At least 2 measurements (not on the same day) within 4 weeks of the screening period, and each measurement must meet this criterion.\n4. If treated with SGLT2i, angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARBs), mineralocorticoid receptor antagonists (MRAs) before screening, a stable dose of \\>=4 weeks is required unless there are contraindications or intolerance. (For subjects who are intolerant to the above drugs, they can still be included if judged by the investigator to be suitable to participate in the investigator.) )\n5. Volunteer to participate in the study and sign the ICF.\n6. Female of childbearing potential or male subjects with partners of childbearing potential agree to use effective contraception from the start of study treatment until 3 months after the end of the last dose.\n\nExclusion Criteria:\n\n1. History or evidence of any of the following diseases: 1) Diagnosis of type 1 diabetes or other special type diabetes. 2) Presence of non-recovered acute kidney injury (AKI) at screening. 3) Previous or current suffering: bilateral renal artery stenosis (stenosis\\>=50%), tubulointerstitial nephritis, lupus nephritis, autosomal dominant polycystic kidney disease (ADPKD) and autosomal recessive polycystic kidney disease (ARPKD), anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, unilateral nephrectomy or other severe renal structural abnormalities, and a history of unstable or rapidly progressing kidney disease as judged by the investigator. 4) Poorly controlled hypertension (systolic blood pressure \\>=160 mmHg and\u002For diastolic blood pressure \\>=100 mmHg at screening). 5) Glycated hemoglobin (HbA1c) \\>= 9.5%. 6) Presence of serious illness or medical condition judged by the investigator during the screening period, including but not limited to: a) History of malignant tumor disease within 5 years prior to screening (except for cured basal cell or squamous cell carcinoma of the skin and carcinoma in situ at any site); b) Arterial\u002Fvenous thrombotic events within 6 months prior to screening, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction \\[except old lacunar cerebral infarction\\]), deep vein thrombosis; c) History of internal myocardial infarction or surgery such as percutaneous coronary intervention and coronary artery bypass grafting 6 months before screening; d) History of internal heart failure 6 months prior to screening, with New York Heart Association (NYHA) functional class III. or IV. 7) Combined with gastroparesis or other diseases related to gastrointestinal emptying disorders (such as pyloric obstruction, intestinal obstruction, etc.), uncontrolled gastroesophageal reflux disease, gastrointestinal diseases assessed by the investigator as increasing the risk after medication (such as severe active ulcers, inflammatory bowel disease, acute gastroenteritis, symptomatic chronic gastroenteritis), or undergoing major upper gastrointestinal surgery. 8) History of pancreatitis or pancreatic injury, or pancreatic surgery. 9) History of symptomatic gallbladder disease within 2 years prior to screening, defined as imaging examination suggesting the presence of gallstones and diagnosis-related symptoms related to gallstones; Subjects who have undergone gallstone surgery and\u002For cholecystectomy (surgery completed at least 3 months prior to screening) with no long-term complications may participate in this study. 10) History or family history of medullary thyroid carcinoma (MTC), multiple endocrine neoplasia (MEN) type 2. 11) History of acute complications of diabetes (diabetic ketoacidosis, diabetic lactic acidosis, hyperglycemic hyperosmolar state, etc.) within 6 months prior to screening. 12) Severe retinal and macular degeneration (including but not limited to proliferative retinopathy, macular edema, retinal detachment, etc.) in the past or at screening, which require further urgent treatment as judged by the investigator. 13) Severe chronic complications of diabetes (including but not limited to severe diabetic neuropathy, diabetic foot, etc.) at screening, and the investigator judges that this complication may affect the compliance and safety of the subjects. 14) Severe hypoglycemia or recurrent symptomatic hypoglycemia within 6 months prior to screening (\\>=2 times within half a year). 15) Abnormal thyroid function that cannot be controlled with a stable dose of medication, or clinically significant abnormalities in thyroid function test results at screening that require initiation of treatment; 16) History of depression or patient health status questionnaire-9 (PHQ-9) score \\>=15 points at screening; or a history of severe mental illness (including but not limited to suicidal tendencies or suicide attempts, schizophrenia, bipolar disorder, etc.).\n2. Medication history within 3 months prior to randomization that meets any of the following conditions: 1) Receive dipeptidyl peptidase 4 (DPP-4) inhibitors, amylin analogues, glucagon-like peptide-1 (GLP-1) analogues, glucose-dependent insulinic polypeptide (GIP) analogues, glucagon (GCG) analogues. 2) Systemic use of steroid glucocorticoids or immunosuppressants (except for topical or intraarticular, intranasal, and inhaled glucocorticoids; Short-term \\[\\\u003C= 7 days\\] use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases). 3) Use of over-the-counter weight loss drugs (including but not limited to orlistat) or food inhibitors (including traditional Chinese medicine), or treatment with lipid-dissolving injections (e.g., lipolysis injections) within 3 months prior to screening.\n3. Those who have any of the following test abnormalities during screening: 1) Severe anemia (hemoglobin \\\u003C 7.0 g\u002FdL); 2) Abnormal liver function (ALT or AST \\>= 3 ×upper limit of normal \\[ULN\\], or serum total bilirubin \\[TBIL\\] \\>= 1.5 × ULN); 3) Serum albumin \\\u003C 30 g\u002FL; 4) Serum potassium \\> 5.5 mmol\u002FL; 5) Fasting triglycerides \\>= 5.6 mmol\u002FL; 6) International normalized ratio (INR) \\>= 1.5 × ULN; 7) Serum calcitonin level \\> 50 ng\u002FL; 8) Serum amylase or lipase \\> 2.0× ULN. 9) Positive hepatitis B surface antigen (HBsAg) test and hepatitis B virus deoxyribonucleic acid (HBV-DNA) higher than the lower limit of detection, positive hepatitis C virus antibody test (HCV-Ab) and hepatitis C virus ribonucleic acid (HCV-RNA) above the upper limit of the reference value range, positive human immunodeficiency virus antibody (HIV-Ab) test at screening, syphilis antibody (TP- Ab) Those who test positive (RPR titer or TRUST test is required, except for cured syphilis). 10) Clinically significant electrocardiogram (ECG) abnormalities at screening (meeting one of them): a) Second or third degree atrioventricular block; b) Long QT syndrome; or QTcF \\> 470ms for women and \\> 450ms for males；c) pre-excitation syndrome; d) Other severe arrhythmias requiring treatment; e) Heart rate \\\u003C 50 beats\u002Fmin or \\> 110 beats\u002Fmin.\n4. Body weight change of more than 5% within 6 weeks prior to screening.\n5. Those who have had or plan to undergo bariatric surgery during the trial.\n6. Those with a history of alcohol and drug abuse.\n7. Those who are allergic to the study drug or its excipients.\n8. Those who have participated in other clinical trials within 30 days before screening (except for screening only but not medicated or non-interventional studies) or within 5 half-lives of using investigational drugs, whichever is longer.\n9. Subject is receiving dialysis\u002Fkidney transplantation or plans to undergo dialysis\u002Fkidney transplantation during the study.\n10. Pregnant or lactating women.\n11. Other conditions that the investigator considers unsuitable for participation in the study.","75 Years",{"count":171,"type":20},180,[114],"This multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of UBT251 injection in obese\u002Foverweight chronic kidney disease (CKD) population",[26,175],"Chronic Kidney Disease","2025-11-19",{"date":178,"type":37},"2025-11-25",{"date":180,"type":37},"2025-09-01",{"date":182,"type":20},"2030-07-11",{"name":184,"class":185},"The United Bio-Technology (Hengqin) Co., Ltd.","INDUSTRY",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":193,"sex":15,"minAge":110,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":21,"phases":197,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":75},"100611837","phase-1-phase-12a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-pharmacodynamics-and-effect-on-body-weight-of-rn3161-as-monotherapy-and-in-combination-with-tirzepatide-in-adults-with-overweight-and-obesity-100611837","NCT07245771","Phase 1\u002F2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect on Body Weight of RN3161 as Monotherapy and in Combination With Tirzepatide in Adults With Overweight and Obesity","A Randomized, Double-Blind, Placebo-Controlled Phase 1\u002F2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect on Body Weight of RN3161 as Monotherapy and in Combination With Tirzepatide in Adults With Overweight and Obesity","Inclusion Criteria:\n\n* BMI:\n\nObesity: BMI ≥ 30 kg\u002Fm² for participants with no Asian ancestry and ≥ 27.5 kg\u002Fm² for participants with Asian ancestry that has been stable (± 5%) for the previous 3 months (based on participant self-report or available medical records), with or without a weight-related comorbidity (excluding diabetes)\n\nOverweight: BMI 27 to \\\u003C30 kg\u002Fm² for participants with no Asian ancestry and 23.0 to \\\u003C27.5 kg\u002Fm² for participants with Asian ancestry that has been stable (± 5%) for the previous 3 months (based on participant self-report or available medical records), with at least 1 weight-related comorbidity (excluding diabetes)\n\nWeight-related comorbidities include a diagnosis of the following:\n\n* Hypertension: seated BP ≤ 140\u002F90 mm Hg; receiving ≤ 2 stable (≥ 4 weeks) agents limited to ACE inhibitors, angiotensin receptor blockers, calcium channel blockers, or thiazide ≤ 25 mg, or untreated\n* Dyslipidemia: stable use of lipid-lowering agents for dyslipidemia (LDL-C \\\u003C 150 mg\u002FdL, triglycerides \\\u003C 300 mg\u002FdL)\n* Osteoarthritis\n\nExclusion Criteria:\n\n* self-reported or documented weight gain or loss \\>5% within 3 months prior to screening\n* use of GLP1R agonists within 6 months of screening\n* intolerance to GLP-1 medications in the past\n* use of non-GLP1R medications for weight loss within 3 months of screening\n* HbA1c \\>6.5%\n* diagnosis of significant liver disease\n* history of malignancy or anaphylaxis\n* use of any siRNA agent in the prior 12 months",true,"65 Years",{"count":196,"type":20},104,[198,114],"PHASE1","Study to assess the safety, pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body) of RN3161 alone (healthy volunteers) and RN3161 with tirzepatide (overweight and obese subjects)",[26],[30,31,202],"healthy volunteers","2025-11-17",{"date":205,"type":37},"2025-11-24",{"date":207,"type":37},"2025-11-04",{"date":209,"type":20},"2027-08-15",{"name":211,"class":185},"Ikaria Bioscience Pty Ltd",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":21,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":75},"100601730","spontaneous-breathing-trials-using-pressure-support-or-t-piece-in-overweight-and-obese-patients-100601730","NCT07114289","Spontaneous Breathing Trials Using Pressure Support or T-Piece in Overweight and Obese Patients","Comparison of Pressure Support Ventilation and T-Piece as Spontaneous Breathing Trials Before Extubation Among Obese and Overweight Patients","Inclusion Criteria:\n\n1\\. Patients had undergone intubation and mechanical ventilation for more than 24 hours prior to the first spontaneous breathing trial.\n\n2\\. Adult patients aged ≥ 18 years. 3. BMI ≥ 25 kg\u002Fm². 4. Meeting all the Inter national Consensus Conference on weaning criteria:\n\n1. Stable vital signs: heart rate \\\u003C 140 beats\u002Fmin, systolic blood pressure: 90-160 mmHg, and no use of vasopressors or use of minimal doses (\\\u003C0.2 µg\u002Fkg per min).\n2. Respiratory rate ≤ 35 breaths\u002Fmin.\n3. Adequate oxygenation, defined as either SpO2 \\> 90% with FiO2 ≤ 0.4, or PaO2\u002FFiO2 \\> 150 mmHg with positive end-expiratory pressure (PEEP) ≤ 8 cmH2O.\n4. Adequate cough strength (MIP \\\u003C -20 cmH2O).\n5. An awake state, defined as a score of Richmond Agitation-Sedation Scale between +1 and -2, or Glasgow Coma Scale \\> 8.\n6. No continuous sedation. 5. Informed consent provided by the patient or their relatives.\n\nExclusion Criteria:\n\n1. Patients with tracheostomy.\n2. Patients who had been admitted for traumatic brain injury.\n3. Patients who had preexisting peripheral neuromuscular disease (underlying myopathy or myasthenia gravis).\n4. Patients who had a do-not-reintubate order at the time of the initial spontaneous breathing trial were excluded\n5. Patients who have already undergone a first spontaneous breathing trial.\n6. Patients who had undergone extubation without an SBT\n7. Protected populations: pregnant or breastfeeding women, individuals under guardianship, or those under legal protection.\n8. Patients who refused to participate during the study.",{"count":220,"type":20},100,[23],"This study aims to find out which method of spontaneous breathing trial (SBT) better helps overweight and obese ICU patients prepare for extubation, which is the removal of the breathing tube. The two methods being compared are pressure support ventilation (PSV) and the T-piece.\n\nParticipants are adults with a body mass index (BMI) of 25 or higher who have been on a breathing machine (invasive mechanical ventilation) for more than 24 hours. Before removing the breathing tube, participants will be randomly assigned to receive either a PSV or a T-piece trial for 1 hour. After that, doctors will decide if they are ready for extubation.\n\nThe main question this study wants to answer is: Which method leads to a higher rate of successful extubation-defined as not needing to be reintubated within 72 hours?",[224,225,26,226],"Mechanical Ventilation","Extubation","Respiratory Failure","2025-11-13",{"date":203,"type":37},{"date":230,"type":37},"2025-09-29",{"date":232,"type":20},"2027-07-31",{"name":234,"class":44},"Taipei Medical University Hospital",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":169,"enrollmentInfo":243,"targetDuration":4,"studyType":21,"phases":244,"briefSummary":245,"conditions":246,"keywords":248,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":75},"100609341","probiotic-intervention-for-digestive-health-in-obese-patients-initiating-glp-ra-treatment-100609341","NCT07213323","Probiotic Intervention for Digestive Health in Obese Patients Initiating GLP-RA Treatment","Evaluation of the Efficacy of Probiotics on Digestive Quality of Life in Patients Initiating GLP-1 Receptor Agonists for the Treatment of Obesity. A Randomized, Double-blind Trial","PROBIO-GLP1","Inclusion Criteria:\n\n* Patient who is going to start a GLP-1 RA (semaglutide or tirzepatide) for weight management\n* Men or Women\n* BMI ≥ 30 kg\u002Fm2 or BMI ≥ 27 kg\u002Fm2 associated with one or more co-morbidities (arterial hypertension, sleep apnea, dyslipidemia, arthritis)\n* Between 18 and 75 years old\n* In the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements as described in the protocol (e.g. transportation to and from trial site, ability to understand and fill the self-rating scales, drug compliance, availability to attend to the scheduled visits, etc…).\n* Patient who agrees to be included in the study and who signs the informed consent form\n* Female participants of childbearing potential must agree to use effective contraception\n* Patient affiliated to a healthcare insurance plan\n\nExclusion Criteria:\n\nCriteria relating to the study population:\n\n* Patients under 18 years old\n* Patient with contraindication to semaglutide or tirzepatide according to the Summary of Product Characteristics (SPC).\n* Patients scheduled for bariatric surgery during the study period\n* Patients who have had bariatric surgery in the last 12 months\n* Patient with a current diagnosis of diabetes.\n* Patients with a current diagnosis of liver cirrhosis, short bowel syndrome or inflammatory bowel disease (IBD).\n* Patients with severely weakened immune system.\n* Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease.\n\nProduct criteria:\n\nPatient with known allergy to the product of the study\n\nProhibited treatments :\n\nCurrent associated treatments or used in the last 30 days: GLP-1 RA, Anti-obesity drugs (AOD), Corticosteroids, Atypical neuroleptics, Antibiotics, Probiotics, Prebiotics\n\nRegulatory criteria :\n\n* Persons deprived of their liberty by a judicial or administrative decision\n* Persons under psychiatric care\n* Persons admitted to a health or social institution for purposes other than research\n* Adults subject to a legal protection measure (guardianship, curatorship)\n* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme\n* Subjects participating in other interventional research with an exclusion period still in progress at pre-inclusion",{"count":19,"type":20},[23],"Obesity is a prevalent chronic disease affecting 17% of the French population. Treatment involves multiple factors, with pharmacotherapy playing an increasingly important role. GLP-1 receptor agonists (GLP1 RAs) are considered revolutionary in obesity treatment, with three approved molecules available in France: liraglutide, semaglutide, and tirzepatide. These treatments, combined with a healthy lifestyle, induce significant weight loss: 9% with liraglutide, 15% with semaglutide, and 20% with tirzepatide.\n\nThe most common adverse events (AEs) associated with GLP-1 RAs are gastrointestinal (GI) disorders, including nausea, vomiting, diarrhea, and abdominal pain. These AEs are dose-dependent and often decline over time. In phase 3 trials, semaglutide 2.4 mg showed higher rates of GI AEs compared to placebo, but most were mild to moderate and transient. GI AEs led to dose reduction or temporary treatment interruption in 12.5% of participants, with few permanent discontinuations.\n\nProbiotics, are live microorganisms that benefit the host by improving gut microflora. Probiotics has been clinically proven to benefit gastrointestinal health. Probiotics may reduces symptoms of irritable bowel syndrome (IBS), improves gut barrier function, reduces inflammation, and decreases the incidence of C. difficile infection (CDI) in patients taking antibiotics.\n\nProbiotics is therefore theorized to potentially reduce GI side effects associated with GLP-1 RA treatment for obesity.\n\nHypothesis Probiotics will prevent and limit the digestive disorders induced by GLP-1 R agonists, particularly during the dose escalation period. This would allow better digestive tolerance of the treatments, limiting the number of definitive treatment interruptions, facilitating compliance and dose escalation with a larger number of subjects at full dose and therefore with better systemic exposure to the compounds, a key factor in their effects on weight loss.",[26,247],"Digestive Disorders",[249,250,251],"GLP1 R-agonist","Probiotics","Quality of life",{"date":253,"type":37},"2025-10-08",{"date":255,"type":20},"2025-12-15",{"date":257,"type":20},"2027-12-15",{"name":259,"class":44},"Hospices Civils de Lyon",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":15,"minAge":267,"maxAge":169,"enrollmentInfo":268,"targetDuration":4,"studyType":21,"phases":270,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100607723","phase-3-study-to-evaluate-the-efficacy-and-safety-of-in-b00009-injection-in-adults-with-obesity-or-overweight-without-diabetes-mellitus-100607723","NCT07192263","Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes Mellitus","A Phase 3, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes Mellitus","Inclusion Criteria:\n\n1. Aged 19 to 75 years as of the date of written consent\n2. Those who meet any of the following obesity criteria at the screening visit\n\n   * BMI ≥ 30 kg\u002Fm2\n   * 27 kg\u002Fm2 ≤ BMI \\\u003C 30 kg\u002Fm2 with at least one risk factor or comorbidity\n\n     * BMI (kg\u002Fm2) = weight (kg) \u002F height (m)2\n\n       * Hypertension: Taking antihypertensive medication or sitSBP ≥ 140 mmHg or sitDBP ≥ 90 mmHg\n       * Dyslipidemia: Taking dyslipidemia medication or Total Cholesterol ≥ 240mg\u002FdL or LDL-C ≥ 160 mg\u002FdL or TG ≥ 200 mg\u002FdL or HDL-C \\\u003C 40 mg\u002FdL\n       * Obstructive sleep apnea\n       * Cardiovascular and cerebrovascular diseases: Ischemic cardiovascular and cerebrovascular diseases not corresponding to exclusion criterion 17, heart failure of NYHA Class I to III, etc.\n       * Prediabetes: 100 mg\u002FdL ≤ FPG ≤ 125 mg\u002FdL or 140 mg\u002FdL ≤ PG ≤ 199 mg\u002FdL at 2 hours after 75 g oral glucose load or 5.7% ≤ HbA1c ≤ 6.4%\n3. Self-reported history of at least one failed attempt at weight control using diet and exercise therapy prior to the screening visit\n4. Able to agree to and follow the reduced-calorie diet and exercise therapy recommended in this study during the study period\n5. Agrees to use a medically appropriate method of contraception (including medically infertile conditions) during the study period\n\nExclusion Criteria:\n\n1. Body weight change exceeding 5 kg within 3 months of the screening visit\n2. Diabetes (Type 1, Type 2, etc.) or HbA1c ≥ 6.5% at the screening visit\n3. Received any of the following medications or treatments within 3 months of the screening visit\n\n   ① Obesity-related medications (such as GLP-1 receptor agonists) or medications including over-the-counter drugs, herbal medicines, or health functional foods for weight control\n\n   ② Received hypoglycemic agent or requires continuous administration during the study period\n\n   ③ Received systemic steroids for 30 consecutive days or more, or requires continuous administration during the study period\n\n   ④ Received other medications that cause significant body weight changes or requires continuous administration during the study period (e.g.: antipsychotics, tricyclic antidepressants, selective serotonin reuptake inhibitors, noradrenergic and specific serotonergic antidepressant, mood stabilizers (lithium), anticonvulsants, serotonin antagonists, first-generation antihistamines, etc.)\n4. Diagnosed with obesity due to endocrine disorders (hypothalamic obesity, Cushing's syndrome, insulinoma, adult growth hormone deficiency, hypothyroidism, etc.)\n5. Diagnosed with obesity due to genetic variations and congenital disorders\n\n   * Obesity-causing genes: ob, db, Proopiomelanocortin (POMC), Melanocortin 4 receptor (MC4R) genes, etc.\n   * Congenital disorders: Prader-Willi syndrome, Laurence-Moon-Biedl syndrome, Alström syndrome, Cohen syndrome, Carpenter syndrome, etc.\n6. History of bariatric surgery (e.g., adjustable gastric banding, sleeve gastrectomy, Roux-en-Y gastric bypass, biliopancreatic diversion\u002Fduodenal switch, etc.) or device procedures, or plans for such during the study period\n\n   * However, those who have had devices (e.g., gastric band, intragastric balloon) removed for more than 1 year can participate\n   * Those who have had liposuction or abdominoplasty for more than 1 year can participate\n7. Clinically significant gastrointestinal disorders (e.g., gastroparesis, gastric outlet obstruction, peptic ulcer, severe gastroesophageal reflux disease)\n8. History (including family history) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or results of clinical laboratory test at the screening visit meeting the following:\n\n   * Calcitonin ≥ 100 ng\u002FL\n   * TSH \\\u003C 0.6 mIU\u002FL or TSH \\> 6.8 mIU\u002FL (However, subjects being treated for hypothyroidism with 0.6 mIU\u002FL ≤ TSH ≤ 6.8 mIU\u002FL, taking stable doses of thyroid hormonal preparation for 3 months prior to the screening visit and unlikely to have dose changes during the study period can participate)\n9. History of acute or chronic pancreatitis, or results of clinical laboratory test at the screening visit meeting the following:\n\n   \\- Amylase or Lipase \\> 3 times the upper limit of normal\n10. Severe hepatic impairment or results of clinical laboratory test at the screening visit meeting the following:\n\n    \\- AST or ALT \\> 3 times the upper limit of normal or Total bilirubin \\> 2 times the upper limit of normal\n11. Severe renal impairment (eGFR \\\u003C 30mL\u002Fmin\u002F1.73m2)\n12. Uncontrolled hypertension (sitSBP ≥ 160 mmHg or sitDBP ≥ 100 mmHg) at the screening visit\n13. Answered \"yes\" to question 4 or 5 in the suicidal ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or history of suicide attempt\n14. Score of 15 or higher on the Patient Health Questionnaire-9 (PHQ-9) at the screening visit, or history of major depressive disorder with unstable state, anxiety, or other severe psychiatric disorders (schizophrenia, bipolar disorder, etc.) within 2 years\n15. History of alcohol addiction or drug abuse within 3 months of the screening visit\n16. History of malignant tumor within the last 5 years\n\n    * Those who have been determined as complete remission (CR, pCR) of the tumor and had no relapse for 5 years or more from the date of assessment can participate\n    * Those with a history of thyroid cancer (excluding MTC), basal cell and squamous cell skin cancer within the last 5 years can participate\n17. Any of the following medical histories confirmed within 3 months of the screening visit\n\n    * Heart failure of NYHA class IV\n    * Coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI)\n    * Ischemic heart disease (acute myocardial infarction, unstable angina, etc.). However, if the condition has been stable for 6 months or more from the screening visit, participation is possible at the investigator's discretion\n    * Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), transient ischemic attack (TIA). However, if the condition has been stable for 6 months or more from the screening visit, participation is possible at the investigator's discretion\n18. History of non-arteritic anterior ischemic optic neuropathy (NAION)\n19. History of resistance or hypersensitivity to investigational product class drugs (GLP analogues) or history of multi-drug allergies\n20. Requires administration of contraindicated medications during the study period\n21. Received other investigational products within 30 days or 5 times the half-life (whichever is longer) if the half-life is known, prior to the screening visit\n22. Positive for HBsAg, HCV antibody, or HIV antibody at the screening visit\n\n    \\- However, those who are HCV-Ab positive but confirmed negative in HCV-RNA test can participate\n23. Hematological conditions that may interfere with HbA1c measurement (e.g.: hemolytic anemia, hemoglobinopathies)\n24. Scheduled for surgery requiring hospitalization during the study period or requires surgical treatment\n25. Positive pregnancy test, pregnant or lactating women\n26. Considered inappropriate as a study subject by the investigator for other reasons","19 Years",{"count":269,"type":20},300,[271],"PHASE3","This Phase 3 study is designed to evaluate the efficacy and safety of IN-B00009 injection in adults with obesity or overweight without diabetes mellitus",[26],"2025-09-21",{"date":276,"type":37},"2025-09-25",{"date":278,"type":20},"2025-09-22",{"date":280,"type":20},"2027-09-30",{"name":282,"class":185},"HK inno.N Corporation",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":290,"enrollmentInfo":291,"targetDuration":293,"studyType":294,"phases":4,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":4},"100607101","validation-of-heart-rate-monitors-in-overweight-and-obese-young-adults-100607101","NCT07184177","Validation of Heart Rate Monitors in Overweight and Obese Young Adults","Validation of the Accuracy of Heart Rate Monitors at Resting and Exercise at Maximal Fat Oxidation Rate in Overweight and Obese Young Adults","Inclusion Criteria:\n\n* Body mass index ≥ 25 kg\u002Fm2\n* Energy expenditure \\\u003C 600 METs a week\n* Acceptance of informed consent\n\nExclusion Criteria:\n\n* ≥100 mL of alcohol consumption per week\n* Have limitations to perform regular physical activity\n* Have a chronic non-communicable disease\n* Answer \"yes\" to any of the questions on the Physical Activity Readiness-Questionnaire for Everyone (PAR-Q+), which represents a health risk.","25 Years",{"count":292,"type":20},52,"1 Day","OBSERVATIONAL","Overweight and obesity are defined as an excessive accumulation of body fat that affects health. According to data from the World Health Organization (WHO), in 2022, there were 2.5 billion adults aged 18 years and older who were overweight, of whom 890 million were obese. In other words, 43% of adults aged 18 years and older were overweight, and 16% of them were obese.\n\nOverweight and obesity are key risk factors for various chronic diseases such as diabetes, hypertension, cardiovascular disease, and even some types of cancer. There is evidence that mortality from cardiovascular disease, and the incidence of cancer and diabetes, varies according to the amount of physical activity. In the context of high levels of sedentary time, higher levels of moderate to vigorous physical activity are recommended. There are various ways to treat overweight and obesity, the main ones usually being lifestyle changes, such as following a healthy diet and regular physical activity, as well as following pharmacological treatments. In this project, the focus will be on the fat metabolism generated during moderate physical activity.\n\nThere are physical activity interventions aimed at increasing fat metabolism that may potentially reduce the symptoms of metabolic diseases such as obesity and type 2 diabetes. For this purpose, it is important to understand the factors that increase or decrease fat oxidation. Factors such as exercise intensity and duration are important to understand when determining maximum fat oxidation (FatMax).\n\nThe aim is to develop comprehensive research that will generate knowledge and evidence on health issues with social impact through the evaluation of commercial technologies and innovative actions that promote the prevention, treatment, and resolution of national health problems such as obesity.",[26],"2025-09-18",{"date":299,"type":37},"2025-09-19",{"date":301,"type":20},"2026-01-19",{"date":303,"type":20},"2026-12-04",{"name":305,"class":44},"Universidad Autonoma de Baja California",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":194,"enrollmentInfo":314,"targetDuration":4,"studyType":21,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":322,"leadSponsor":324,"locationsCount":75},"100606143","phase-1-studying-the-influence-of-leap2-on-integrated-endocrine-control-of-eating-during-semaglutide-treatment-100606143","NCT07171723","Studying the Influence of LEAP2 on Integrated Endocrine Control of Eating During Semaglutide Treatment","Effects of Antagonizing the Ghrelin Receptor in Individuals With Obesity on Treatment With Semaglutide","SILENCED","Inclusion Criteria:\n\n* Age between 18 and 65 years old\n* Body mass index (BMI) above ≥ 25 kg\u002Fm2\n* Ongoing semaglutide treatment with a stable dose of ≥ 1 mg once weekly for a minimum of 3 months prior to inclusion\n* Weight stability, defined as a maximum variation of ±3% between the highest and lowest recorded body weight during the 3 months prior to inclusion.\n* Informed oral and written consent\n\nExclusion Criteria:\n\n* Anaemia\n* Alanine aminotransferase (ALAT) \\> 2 times normal value\n* History of hepatobiliary and\u002For gastrointestinal disorder\n* Kidney disease (serum creatinine above normal range and\u002For urine albumin-creatinine ratio 30mg\u002Fg confirmed with two measurements)\n* Any ongoing medication that investigator evaluates would interfere with study participation\n* Any physical or psychological condition that investigators evaluate would interfere with study participation including any acute or chronic illnesses.\n* Regular tobacco smoking and\u002For use of other nicotine products\n* Glycated haemoglobin HbA1c \\> 48 and\u002For type 1 or type 2 diabetes medical treatment\n* Women of childbearing potential who are not using effective contraception\n* Pregnancy or breastfeeding",{"count":315,"type":20},24,[198,114],"This clinical study investigates how blocking the hunger-related ghrelin receptor affects appetite and metabolism in individuals with obesity who are treated with semaglutide (a GLP-1 receptor agonist). LEAP2, a naturally occurring hormone that inhibits the ghrelin receptor, is used as the investigational compound. The objective of the study is to clarify how the ghrelin system functions when appetite is suppressed by semaglutide treatment. Participants will receive either LEAP2 or placebo during two experimental visits in a randomized, double-blind, crossover design. The investigators will assess food intake, appetite sensations, glucose metabolism, and hormonal responses. By examining the interaction between semaglutide and ghrelin signaling, the study aims to improve understanding of how multiple appetite-regulating systems interact and whether additional hunger signals remain active during GLP-1 treatment. The findings may inform the development of future treatments for individuals with obesity.",[26],"2025-09-12",{"date":297,"type":37},{"date":180,"type":37},{"date":323,"type":20},"2026-02-01",{"name":325,"class":44},"University Hospital, Gentofte, Copenhagen",{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":15,"minAge":194,"maxAge":4,"enrollmentInfo":332,"targetDuration":293,"studyType":294,"phases":4,"briefSummary":334,"conditions":335,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":347,"locationsCount":75},"100606808","assessment-and-management-of-multiple-drug-use-in-elderly-chronic-disease-patients-100606808","NCT07180368","Assessment and Management of Multiple Drug Use in Elderly Chronic Disease Patients","Inclusion Criteria:\n\n* Patients aged 65 years or older with at least one chronic disease\n\nExclusion Criteria:\n\n* Patients without chronic diseases\n* Patients refused to participate in the study\n* Patients with unstable vital signs",{"count":333,"type":20},2000,"The purpose of this observational study is to understand the impact of polypharmacy on the prognosis of elderly patients with chronic diseases. The main research question it aims to address is:\n\nDoes polypharmacy affect the prognosis of elderly patients with chronic diseases? Elderly patients with chronic diseases will be asked to complete online survey questions regarding their disease prognosis over a 2-year period.",[336,337,175,145,338,339,26,340,341],"Coronary Artery Disease","Diabete Mellitus","Heart Failure","Hyperlipidemia","Chronic Obstructive Pulmonary Disease (COPD)","Stroke","2025-09-11",{"date":297,"type":37},{"date":345,"type":37},"2024-10-01",{"date":280,"type":20},{"name":348,"class":44},"Xijing Hospital",{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":15,"minAge":357,"maxAge":16,"enrollmentInfo":358,"targetDuration":4,"studyType":21,"phases":360,"briefSummary":361,"conditions":362,"keywords":363,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":75},"100605163","effectiveness-of-a-family-support-model-for-prevention-and-management-of-overweight-and-obesity-in-children-6-12-years-100605163","NCT07158944","Effectiveness of a Family Support Model for Prevention and Management of Overweight and Obesity in Children 6-12 Years","A Coherent Family Support Model (Co-Fam) for Prevention and Management of Childhood Obesity: Protocol for a Hybrid Type 2 Effectiveness-implementation Trial","Co-Fam","Inclusion Criteria:\n\n* A parent of a child between 6-12 years of age.\n* The child attends a school providing the Healthy School Start program.\n* The child has been diagnosed with overweight (age standardized BMI of 25 or above) or obesity (age standardized BMI of 30 or above) by a health care personnel.\n\nExclusion Criteria:\n\n\\- If parents are unable to understand and\u002For communicate in easy Swedish.","6 Years",{"count":359,"type":20},126,[23],"The study will evaluate a coherent model of family support including school health care, primary health care and pediatric clinics. The model combines two evidence based programs: the universal \"A Healthy School Start\" provided to all children and their families during grade 1 and the targeted parental support program \"More and Less\" provided to parents of children with overweight or obesity.\n\nThe hypothesis is that combining the Healthy School Start and More and Less programs in a coherent model will increase the collaboration between regional and municipal stakeholders, ensure early identification of families in need, ultimately improving prevention and treatment of childhood overweight and obesity. The aim of this study is to evaluate the implementation of a coherent model of family support provided through school and primary health care.",[26],[364,365,366,367],"Prevention","Obesity treatment","Parental support","Children",{"date":369,"type":37},"2025-09-17",{"date":371,"type":20},"2025-09",{"date":373,"type":20},"2028-12",{"name":375,"class":44},"Karolinska Institutet",{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":193,"sex":15,"minAge":110,"maxAge":169,"enrollmentInfo":384,"targetDuration":4,"studyType":21,"phases":386,"briefSummary":387,"conditions":388,"keywords":391,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":402,"leadSponsor":404,"locationsCount":75},"100606110","precise-eating-time-to-improve-glycemic-control-and-cardiometabolic-health-in-prediabetes-and-diabetes-100606110","NCT07171281","Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes and Diabetes","Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes and Diabetes: the GLYCOTIME Trial","GLYCOTIME","Inclusion Criteria:\n\n* Overweight or obesity (BMI 25-40 kg\u002Fm²)\n* Healthy glucose metabolism (fasting glucose \\\u003C100 mg\u002Fdl and glucose after 2 hours OGTT \\\u003C140 mg\u002Fdl)\n* OR impaired glucose metabolism (fasting glucose 100-125 mg\u002Fdl and\u002For glucose after 2 hours OGTT 140-199 mg\u002Fdl and\u002For HbA1c 5.7-6.4%)\n* OR type 2 diabetes (according to existing medical diagnosis or fasting glucose \\>126 mg\u002Fdl and\u002For glucose after 2 hours OGTT \\>200 mg\u002Fdl and\u002For HbA1c ≥6.5%)\n* Daily eating window ≥12 hours\n\nExclusion Criteria:\n\n* Weight changes \\> 5% within past 3 months\n* Shift work\n* Traveling across more than one time zone within one month prior to the study\n* Pregnancy and breastfeeding\n* Eating disorders, food intolerance\u002Fallergy to ingredients in the diet product, vegan diet, practicing time-restricted eating\n* Severe chronic illnesses or other conditions that are incompatible with the planned intervention and examination program (e.g. type 1 diabetes, recent cardiovascular event, malabsorption, cancer in the last two years, etc.)\n* Treatment with insulin, sulfonylureas, and GLP-1 receptor agonists, steroid use (oral, cutaneous, or parenteral), regular intake of melatonin, anticoagulation treatment that cannot be paused\n* Extreme early and extreme late chronotypes",{"count":385,"type":20},30,[23],"The objective of this study is to investigate the impact of hypocaloric time-restricted eating (TRE) at different day times (early versus late TRE) on glucose metabolism and other cardiometabolic parameters in individuals with overweight and with normal, or impaired glucose metabolism (prediabetes and type 2 diabetes). In addition, the study aims to elucidate the molecular mechanisms underlying these effects.",[389,390,26],"Prediabetes","Type 2 Diabetes",[392,389,390,393,394,395,60,396,397,398],"Time-restricted eating","Chrononutrition","Glucose metabolism","Overweight","Continuous glucose monitoring","TRE","Prevention and treatment of type 2 diabetes","2025-09-10",{"date":319,"type":37},{"date":299,"type":20},{"date":403,"type":20},"2028-02-28",{"name":405,"class":44},"German Institute of Human Nutrition",{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":194,"enrollmentInfo":414,"targetDuration":4,"studyType":294,"phases":4,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":75},"100596224","behavioral-therapy-and-glp-1-analogue-effects-on-binge-eating-weight-and-coping-in-obesity-100596224","NCT07042672","Behavioral Therapy and GLP-1 Analogue Effects on Binge Eating, Weight, and Coping in Obesity","Behavioral Therapy With and Without GLP-1 Analogue in Patients With Morbid Obesity and Binge Eating Disorder: A Clinical Prospective Observational Study on Body Weight, Binge Eating Behavior, and Harmful Coping Strategies","BETTER-GLP1","Inclusion criteria\n\n1. Severe obesity defined as BMI \\>40 kg\u002Fm2 or 35 kg\u002Fm2 with obesity-related comorbidities: coronary artery disease, heart failure, hypertension, atrial fibrillation, cerebral stroke, venous thromboembolism, obstructive sleep apnea, obesity hypoventilation syndrome, type 2 diabetes mellitus, non-alcoholic fatty liver disease, dyslipidemia, osteoarthritis and polecystic ovary syndrome\n2. Age between 18 to 65 years\n3. Diagnosis of BED according to DSM-5 criteria\n4. Willingness to participate and provide informed consent\n5. Able to understand and communicate in Norwegian\n\nExclusion criteria\n\n1. Pregnant or lactating women, as well as women planning pregnancy within one year.\n2. Current use medications with major effects on appetite regulation or weight (including, but not limited to systemic glucocorticoids and antipsychotic medication)\n3. Renal failure with estimated glomerular filtration rate less than 30 mL\u002Fmin\u002F1,73m2\n4. Liver failure with either ASAT and\u002For ALAT 5 times upper reference limit, or ALP and\u002For GT more than 3 times upper reference limit, or clinical signs of liver decompensation\n5. Active cancer\n6. Previous medullary thyroid cancer\n7. Previous pancreatitis\n8. Active substance abuse (but previous drug abuse accepted)\n9. Medical or psychological treatment within the specialized health care service for eating disorders within the last 6 months.\n10. Ongoing severe psychiatric disease that makes them unable to follow the lifestyle treatment program\n11. Any illness or prior treatment that in the opinion of the investigator would jeopardize the patient's participation in the study or impact integrity and\u002For quality of study data.\n12. Previous bariatric surgery\n13. Use of appetite suppressing drugs (e.g., GLP-1 analogues and\u002For naltrexone\u002Fbupropion) within the last 6 months\n14. Participation in another clinical study involving an investigational medicinal product within 1 month prior to study inclusion",{"count":415,"type":20},80,"This study is a clinical, longitudinal, non-randomized, prospective observational study that seeks to compare the treatment effects and safety of using GLP-1 analogues versus not using appetite suppressants during a lifestyle treatment program that includes individual consultations every fourth month and 10 weeks of CBT-E group therapy in patients with both obesity and BED.\n\nThe primary objective of this study is to evaluate the impact on BED symptomatology, while the secondary objectives include examining the potential adoption of alternative harmful coping mechanisms. Additionally, the study will assess psychological well-being and weight changes and their consequent influence on obesity-associated comorbid conditions.\n\nAdult patients with coexisting obesity and BED presenting at the Obesity clinic at Haukeland University Hospital, Bergen, Norway, will be included Patients will be divided into two groups: Group-GLP1 (n = 40), who will use GLP-1 analogues, and Group-NoMED (n = 40), who will not use appetite suppressants. Both groups will otherwise follow the routine standardized patient care pathway with follow-up controls every four months and participation in CBT group therapy sessions.\n\nChanges in symptoms of BED, alternative harmful coping strategies and mental health will be recorded at baseline and 12 months using patient-reported questionnaires, as well as anthropometric and biochemical data.",[418,419,420,421,120,422,26],"Binge Eating Disorder Associated With Obesity","Binge Eating Disorder","Eating Disorder Binge","Eating Disorders","CBT","2025-09-09",{"date":425,"type":37},"2025-09-15",{"date":427,"type":37},"2025-07-01",{"date":429,"type":20},"2028-12-31",{"name":431,"class":44},"Haukeland University Hospital",{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":15,"minAge":438,"maxAge":439,"enrollmentInfo":440,"targetDuration":4,"studyType":21,"phases":442,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":450,"leadSponsor":452,"locationsCount":4},"100605213","the-impact-of-a-weight-reduction-intervention-on-clinical-outcomes-in-patients-with-obesity-and-copd-100605213","NCT07159594","The Impact of a Weight Reduction Intervention on Clinical Outcomes in Patients With Obesity and COPD","Inclusion Criteria:\n\n* Individuals with COPD, defined by the GOLD criteria, with a forced expiratory volume in one second (FEV1) \\\u003C 80% of predicted and a forced expiratory ratio of \\\u003C70, with a BMI ≥ 30 kg\u002Fm2\n\nExclusion Criteria:\n\n* patients with untreated cardiac disease, renal or hepatic failure, active cancer treatment, diabetes mellitus with prescribed insulin or patients with reported unintentional weight loss in the previous three months, or physical impairment that might affect the exercise capacity.","40 Years","80 Years",{"count":441,"type":20},70,[23],"Obesity and COPD are increasingly common and often coexist, worsening health outcomes such as reduced lung function, exercise capacity, and increased systemic inflammation. While COPD was historically associated with underweight, obesity is now more prevalent among these patients and poses new challenges. Despite some evidence that weight loss may improve lung function, comprehensive interventions have not been fully studied.\n\nThe TRIO-COPD study aims to evaluate a 20-week program combining energy restriction, adequate protein intake, and structured exercise in COPD patients with obesity. The study will assess:\n\nPrimary outcome:\n\n-Exercise capacity (6-minute walking test).\n\nSecondary outcomes:\n\n-Lung function (spirometry and lung volumes), -symptoms ( assessed via questionnaires), body composition (fat mass, fat-free mass, waist circumference), and inflammatory markers (e.g., IL-6, CRP, CC16).\n\nA subgroup will also undergo sputum analysis.\n\nThe study addresses a critical gap, aiming to determine whether structured weight reduction can improve COPD symptoms, reduce inflammation, and limit muscle loss-advancing understanding of obesity's impact on COPD and providing evidence for potential treatment guidelines.",[445,26],"COPD","2025-09-05",{"date":448,"type":37},"2025-09-08",{"date":180,"type":20},{"date":451,"type":20},"2028-06-30",{"name":453,"class":44},"Sahlgrenska University Hospital",{"id":455,"slug":456,"hasResults":11,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":11,"sex":15,"minAge":438,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":21,"phases":462,"briefSummary":463,"conditions":464,"keywords":469,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":475,"leadSponsor":477,"locationsCount":75},"100604666","the-resistant-starch-intervention-for-cognitive-enhancement-100604666","NCT07152483","The Resistant Starch Intervention for Cognitive Enhancement","The Resistant Starch Intervention for Cognitive Enhancement (RICE) in Individuals With High Genetic Risk","Inclusion Criteria:\n\n* Patients aged ≥ 40 years\n* meta-polygenic risk score (metaPRS) \\> 0.4\n* Montreal Cognitive Assessment (MoCA) score ≤ 26\n* Central obesity (waist circumference \\> 90 cm in males or \\> 80 cm in females) or body mass index (BMI) ≥ 28 kg\u002Fm²\n* Written informed consent available\n* Proficient in using smartphones\n* Willingness to complete all assessments and participate in follow-up\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to resistant starch\n* previously diagnosed dementia\n* Suspected dementia after clinical assessment by study physician at screening visit\n* Previous history of major head trauma and any intracranial surgery\n* Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions\n* Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement\n* Severe loss of vision, hearing, or communicative ability\n* Patients presenting a malignant disease with life expectancy \\\u003C 3 years\n* Participation in an ongoing investigational drug study\n* The participant or a first-degree relative is currently participating in another clinical trial involving nutritional intervention.\n\nExit Criteria:\n\n* Not meet the inclusion criteria\n* For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator\n* Any adverse or serious adverse events during the study period judged by Investigator",{"count":441,"type":20},[23],"The investigation will explore the potential effects of resistant starch The Resistant Starch Intervention for Cognitive Enhancement study aimed to evaluate the effect of high-resistant starch diet intervention in slowing cognitive decline among individuals at high genetic risk for cognitive impairment. Participants will be randomly assigned to either an intervention group receiving daily high-resistant starch food products or a control group receiving isoenergetic regular starch products. The investigation will validate the potential effects of resistant starch on cognitive function protection and explore the underlying mechanisms through comprehensive data collection, including standardized neuropsychological assessments, laboratory biomarkers derived from blood and fecal specimens, and multimodal magnetic resonance imaging.",[465,466,467,468,26],"Cognitive Impairment","Diet Interventions","Cognitive Decline","Genetic Risk Factors",[465,466,467,468,470],"Obesity &amp; Overweight","2025-08-26",{"date":473,"type":37},"2025-09-03",{"date":180,"type":20},{"date":476,"type":20},"2026-12-01",{"name":478,"class":44},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":480,"slug":481,"hasResults":11,"nctId":482,"briefTitle":483,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":11,"sex":15,"minAge":54,"maxAge":439,"enrollmentInfo":485,"targetDuration":4,"studyType":21,"phases":486,"briefSummary":487,"conditions":488,"keywords":489,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":75},"100603779","fueling-strong-hearts-for-a-strong-south-carolina-100603779","NCT07140952","Fueling Strong Hearts for a Strong South Carolina","Inclusion Criteria:\n\n1. age 45-80 years;\n2. a diagnosis of stroke at least 6 months prior;\n3. BMI \\> 25 kg\u002Fm2;\n4. ability to follow instructions, complete training, and to communicate exertion, pain, and distress;\n5. access to computer or smart phone with internet to participate in a virtual intervention; and\n6. provision of informed consent. Individuals who meet inclusion criteria must complete the Physical Activity Readiness Questionnaire (PARQ) and be cleared for participation by a study exercise physiologist\n\nExclusion Criteria:\n\n1. unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's;\n2. Alzheimer's or other dementias;\n3. life expectancy \\\u003C1 yr;\n4. history of DVT or pulmonary embolism within 6 months;\n5. severe hypertension with systolic \\>200 mmHg and diastolic \\>110 mmHg at rest;\n6. history of seizures or currently prescribed anti-seizure medications; or\n7. current enrollment in a rehabilitation trial to enhance physical or psychosocial recovery",{"count":19,"type":20},[23],"South Carolina is home to many survivors of stroke. After leaving the hospital and finishing therapies, stroke survivors often do not have the supports they need to fully recover. Many live with problems for a long time after their stroke, such as trouble walking or doing everyday tasks like cleaning, grocery shopping, or cooking. Research suggests that healthy habits, like moving more, eating well, and being at a healthy weight, can improve most of these disabilities. These habits can be hard to form alone though, especially in rural areas that may not have many healthy foods or places to exercise. Research-based programs can help people form healthy habits. These programs have not been tested in stroke survivors who have different needs though. The goal of this research project is to test StrongPeople StrongHearts, a health program, to see if it helps stroke survivors in South Carolina make better choices for their health and improve their quality of life. The program will be delivered online so that survivors in rural areas can be in the program. One group will also receive a weekly grocery box tailored to their needs to improve access to healthy foods. This study could help increase access to research-based programs for stroke survivors who do not have the supports they did soon after their stroke. This step is important for stroke survivors' long-term health and quality of life, the mission of the American Heart Association.",[341,26],[490,491],"Lifestyle Management","Virtual Intervention","2025-08-21",{"date":471,"type":37},{"date":495,"type":37},"2025-06-27",{"date":497,"type":20},"2028-03-31",{"name":499,"class":44},"Clemson University",{"id":501,"slug":502,"hasResults":11,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":508,"targetDuration":4,"studyType":21,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":517,"leadSponsor":519,"locationsCount":75},"100603001","the-mb-eat-smart-teen-study-100603001","NCT07130838","The MB-EAT Smart Teen Study","Effects of Application-Based Mindfulness and Eating Awareness Training on Disordered Eating in Youth With Obesity: The MB-EAT Study","MB-EAT","Inclusion Criteria:\n\n* Have access to a mobile\u002Ftablet device with internet access\n* Are aged 12-17.5 years\n* Are waitlisted or have recently been waitlised for treatment at CHAL at CHEO\n* Are willing and capable to sign consent\u002Fassent forms\n* Have the ability to complete the study in English\n\nExclusion Criteria:\n\n* Are currently enrolled in psychotherapy or a weight management program\n* Have previously been diagnosed with Bulimia Nervosa, purging subtype\n* Have previously been diagnosed with a condition that may impair cognition and neurodevelopment, particularly Fetal Alcohol Syndrome, Down Syndrome, Prader-Willi Syndrome, and Fragile X Syndrome\n* Have previously been diagnosed with ASD\n* Have had a concussion or brain injury in the past 6-months.",{"count":509,"type":20},170,[23],"This two-phase, double-blind, balanced, parallel-group randomized controlled trial evaluates the feasibility, usability, engagement, and clinical impact of an app-based adaptation of the Mindfulness-Based Eating Awareness Training (MB-EAT) program for adolescents living with obesity.\n\nMB-EAT, has been shown to reduce binge eating episodes, improve food-related self-control, and decrease depressive symptoms in adults with obesity. The app based program promotes mindful awareness and self-regulation in response to hunger and satiety cues, without caloric restriction.\n\nYouth aged 12-17.5 years who are waitlisted or have recently been waitlisted for treatment at the Centre for Healthy Active Living (CHAL) at the Children's Hospital of Eastern Ontario (CHEO) will be enrolled in a 4-week app-based MB-EAT program (Phase 1, n=10) to evaluate feasibility, usability, and engagement.\n\nPhase 2 is a 12-week randomized controlled trial with 160 participants who will be randomized to the experimental arm (app-based MB-EAT program; 60-90 minutes\u002Fweek) or an active comparator arm (app-based psychoeducation) to evaluate whether the MB-EAT program improves disinhibited eating. At the end of the intervention, 20 participants will be randomly selected for interviews to explore their experiences with the app.\n\nAdditional secondary outcomes in Phase 2 include depressive symptoms, anxiety symptoms, emotion regulation, dispositional mindfulness, food craving, mindful eating, body image, health-related quality of life, impact of weight on quality of life, internalized weight bias, food impulsivity, and food reinforcement.",[26],"2025-08-18",{"date":515,"type":37},"2025-08-19",{"date":98,"type":20},{"date":518,"type":20},"2028-04-01",{"name":520,"class":44},"Gary Goldfield",{"id":522,"slug":523,"hasResults":11,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":21,"phases":530,"briefSummary":532,"conditions":533,"keywords":537,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":543,"leadSponsor":545,"locationsCount":75},"100602293","phase-4-pharmacokinetics-of-methylphenidate-in-adult-patients-with-attention-deficit-hyperactivity-disorder-100602293","NCT07121621","PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit \u002FHyperactivity Disorder","PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit \u002FHyperactivity Disorder: Comparison Between Patients With and Without OBesity","PHACYLOB","Inclusion Criteria:\n\n* Adults aged 18 and over\n* Diagnosis of ADHD by a psychiatrist, based on DSM-5 criteria (ADHD mixed form, predominantly inattentive or predominantly hyperactive\u002Fimpulsive)\n* Treatment with methylphenidate LP (Ritaline) with a stable dosage for at least two weeks.\n* BMI inclusion criteria: (1) for obese group: BMI ≥ 30 kg\u002Fm2; (2) for non-obese group: BMI \\\u003C 30 kg\u002Fm2.\n* Participant affiliated to a social security scheme\n* Written consent signed by participant\n\nExclusion Criteria:\n\n* Contraindications to methylphenidate treatment\n* Treatment with an oral or nasal decongestant vasoconstrictor; association with a non-selective MAOI antidepressant.\n* Treatment with a proton pump inhibitor within the last 2 weeks.\n* Severe cognitive impairment (clinical evaluation)\n* Severe alcohol use disorder, i.e. at least 6 DSM-5 criteria for substance use disorder (clinical evaluation)\n* Known prior renal impairment\n* Pregnant or breast-feeding women\n* Female patients of childbearing age without at least one acceptable contraceptive method (see definition in Appendix 1)\n* Patients under legal protection\n* Inability of the patient to self-assess the intensity of ADHD symptoms",{"count":385,"type":20},[531],"PHASE4","PHACYLOB PHArmaCokinetics of methYLphenidate in adult patients with Attention-Deficit Hyperactivity Disorder (ADHD) : comparison between patients with and without OBesity.\n\nIts aim is to determine whether, for a comparable treatment dose, there are differences in the pharmacokinetic of methylphenidate between ADHD patients with obesitý and ADHD patients but without obesitý. More specifically, we will assess whether blood concentrations of methylphenidate (MPH; long acting form) are significantly higher or lower in either group at different times of the day.\n\nTo meet this objective, we are conducting this pharmacokinetic clinical trial with blood sampling and repeated clinical measurements just prior to MPH administration (= at T0) and then, at different times after administration, i.e. at times (T): T 30 minutes, T 1 hour, T2h, T3h, T4h, T6h, T8h after MPH administration. As far as MPH is concerned, this is the usual treatment. However, we may hypothesize that the distribution in the body may differ according to weight: hence the interest of this study",[534,535,536,26],"Attention Deficit Hyperactivity Disorder (ADHD)","Obesity (Body Mass Index &Amp;Amp;gt;30 kg\u002Fm2)","Methylphenidate",[536,534,60,538],"Pharmacokinetics","2025-08-12",{"date":541,"type":37},"2025-08-13",{"date":180,"type":20},{"date":544,"type":20},"2026-09-02",{"name":546,"class":44},"University Hospital, Tours",{"id":548,"slug":549,"hasResults":11,"nctId":550,"briefTitle":551,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":194,"enrollmentInfo":554,"targetDuration":4,"studyType":294,"phases":4,"briefSummary":556,"conditions":557,"keywords":558,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":569},"100602056","evaluation-of-the-care-provided-to-patients-who-underwent-bariatric-surgery-and-were-lost-to-follow-up-5-years-after-surgery-100602056","NCT07118540","Evaluation of the Care Provided to Patients Who Underwent Bariatric Surgery and Were Lost to Follow-up 5 Years After Surgery","OBEPER","Inclusion Criteria:\n\n* \\> Patients included in the OBESEPI cohort;\n\n  * Individuals who have received complete information about the organisation of the research and have not objected to their participation and the use of their data;\n  * Affiliation with a social security scheme.\n\nExclusion Criteria:\n\n* \\>Patient who objects to participating in this research;\n\n  * Pregnant and breastfeeding women;\n  * Patients under legal guardianship or curatorship;\n  * Patients deprived of their liberty by a judicial or administrative decision.",{"count":555,"type":20},176,"In 2025, bariatric surgery combined with nutritional and psychological support is one of the most effective treatments for patients with morbid obesity. (2)(3)\n\nHowever, it causes various deficiencies, such as vitamin and iron deficiencies, which justify lifelong personalised vitamin supplementation and, consequently, lifelong medical supervision. The latest recommendations from the French National Authority for Health (Haute Autorité de Santé) clearly state that patients must commit to lifelong medical follow-up after bariatric surgery. (HAS, February 2024, R94). R94. Regular biological monitoring after bariatric surgery is recommended: three times in the first year and then once or twice a year thereafter.\n\nWithin the OBESEPI cohort (clinical trial number NCT02663388), which comprises patients who underwent surgery at Nancy University Hospital between 2013 and 2018, we observed that over 50% of patients were lost to follow-up five years after surgery.",[26],[30,559,31,560],"bariatric surgery","lost to follow-up","2025-08-07",{"date":539,"type":37},{"date":564,"type":37},"2025-06-01",{"date":566,"type":20},"2025-10-10",{"name":568,"class":44},"Central Hospital, Nancy, France",2,{"id":571,"slug":572,"hasResults":11,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":11,"sex":578,"minAge":110,"maxAge":579,"enrollmentInfo":580,"targetDuration":4,"studyType":21,"phases":582,"briefSummary":583,"conditions":584,"keywords":4,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":589,"leadSponsor":591,"locationsCount":75},"100602221","proof-of-concept-in-the-prevention-of-post-bariatric-sarcopenia-simulated-activation-of-the-gravitostat-100602221","NCT07120685","Proof of Concept in the Prevention of Post-bariatric Sarcopenia: Simulated Activation of the \"Gravitostat\"","Proof of Concept in the Prevention of Post-bariatric Sarcopenia: Simulated Activation of the \"Gravitostat\", Randomized Pilot Study","GRAVITOSARC","Inclusion Criteria:\n\n* Female participants\n* Aged between 18 and 60 years\n* Planned for bariatric surgery, such as sleeve gastrectomy\n* Able to give informed consent to participate in research\n* Affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Women weighing 170 kg or more\n* Inability to move around independently.\n* Participants with a spinal pathology.\n* Pregnant or breast-feeding women.\n* Inability to comply with protocol recommendations.\n* Adults under legal guardianship (curatorship, guardianship, deprivation of liberty, patients benefiting from a judicial protection measure or safeguard of justice).\n* Refusal to participate.","FEMALE","60 Years",{"count":581,"type":20},40,[23],"Due to its mechanical and metabolic functions, muscle loss leads to resistance to weight loss during caloric restriction, particularly in patients with obesity. The recent discovery of a \"gravitational\" homeostatic system, induced by an additional load to body weight, suggests the existence of a new weight control mechanism. Such a \"gravitostat\" would ensure a form of weight homeostasis mediated by afferent signals originating from osteocytes in response to gravity perception. This hypothesis, initially derived from animal studies, has more recently been tested in humans. It shows that \"activation of the gravitostat\" through artificial increases in body weight facilitates body weight reduction without affecting lean mass (LM). Therefore, this \"gravitostat\" could contribute to preserving LM despite the loss of fat mass , whereas its decline may compromise muscle mass and function after bariatric surgery, despite undeniable improvements in comorbidities.\n\nThe present study aims to reduce the \"metabolic load\" (i.e., decreasing insulin resistance and inflammation) to promote muscle protein anabolism, while maintaining the \"mechanical load\" (by preserving initial body weight during weight loss induced by bariatric surgery) in order to activate the \"gravitostat\" and preserve muscle mass and function.\n\nCurrently, there are no clear recommendations or strategies to prevent muscle loss in patients who have undergone bariatric surgery. This simple concept, applied during drastic muscle loss, should help improve muscle health.",[26,585],"Bariatric Surgery","2025-08-06",{"date":541,"type":37},{"date":371,"type":20},{"date":590,"type":20},"2027-11",{"name":592,"class":44},"University Hospital, Clermont-Ferrand",{"id":594,"slug":595,"hasResults":11,"nctId":596,"briefTitle":597,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":21,"phases":602,"briefSummary":603,"conditions":604,"keywords":610,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":75},"100602142","targeting-metabolic-syndrome-from-the-emergency-department-through-mixed-methods-pilot-trial-100602142","NCT07119658","Targeting Metabolic Syndrome From the Emergency Department Through Mixed-Methods: Pilot Trial","METS","Inclusion Criteria:\n\n* Ambulatory adults (18 years of age) presenting to the emergency department setting\n* BMI 30 kg\u002Fm2\n* Prior diagnosis of at least one additional comorbid component of metabolic syndrome: hypertension, hyperglycemia, dyslipidemia\n* Clinical plan for discharge\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Pregnant patients\n* Unable to safely ambulate (including patient or family perception of inability to safely ambulate)\n* Lack of access to smart phone\n* Unable or unwilling to wear Fitbit accelerometer device\n* Unable to obtain informed consent",{"count":601,"type":20},20,[23],"The objective of this study is to pilot a multifaceted, optimized intervention for metabolic syndrome (MetS) in emergency department patients to establish feasibility. Participants (n=20) will be randomized to intervention or control (usual care). The composite intervention will include an educational video outlining the adverse effects of MetS and the benefit of walking, a written exercise prescription with a defined goal of walking 150 minutes per week, a Fitbit accelerometer device, resources for healthy eating practices, periodic text message reminders, and an urgent referral to primary care and our health system's Healthy Me clinic for follow-up visit. Investigators hypothesize that this approach will change patient understanding and motivation to increase physical activity and healthy eating habits.",[145,605,606,607,26,608,339,609],"Hyperglycemia","Dyslipidemia","Metabolic Syndrome","Diabetes","Emergency Medicine",[607,611],"Emergency Department","2025-08-05",{"date":541,"type":37},{"date":615,"type":37},"2025-07-08",{"date":617,"type":20},"2026-07",{"name":619,"class":44},"Indiana University",{"id":621,"slug":622,"hasResults":11,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":4,"eligibilityCriteria":626,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":194,"enrollmentInfo":627,"targetDuration":4,"studyType":21,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":75},"100601459","phase-1-phase-ib-clinical-study-on-the-efficacy-and-safety-of-mdr-001-in-patients-who-are-obesity-or-overweight-100601459","NCT07110766","Phase Ib Clinical Study on the Efficacy and Safety of MDR-001 in Patients Who Are Obesity or Overweight","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ib Clinical Study to Evaluate the Efficacy and Safety of Small Molecule MDR-001 Tablets Administered Orally for 12 Weeks Treatment in Overweight or Obesity Participants","Inclusion Criteria:\n\n* Have given written informed consent to participate in this study.\n* Chinese male or female participants who are aged 18-65 (inclusive) years at the time of signing the ICF.\n* Participants who are obesity (BMI ≥ 28.0 kg\u002Fm2), or overweight (24.0 kg\u002Fm2 ≤ BMI \\\u003C 28.0 kg\u002Fm2) with at least one of the following weight-related comorbidities at screening:\n\n  1. Pre-diabetes: 6.1 mmol\u002FL (110 mg\u002FdL) ≤ FPG \\\u003C 7.0 mmol\u002FL (126 mg\u002FdL), and\u002For 5.7% ≤ HbA1c \\\u003C 6.5%.\n  2. Hypertension: Medically documented history of hypertension, or newly diagnosis of hypertension at screening (systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg, measured at least 3 times on different days).\n  3. Dyslipidemia: Medically documented history of dyslipidemia (with or without medication), or at screening TC ≥ 5.2 mmol\u002FL (200 mg\u002Fdl), and\u002For LDL-C ≥ 3.4 mmol\u002FL (130 mg\u002Fdl), and\u002For HDL-C \\\u003C 1.0 mmol\u002FL (40 mg\u002Fdl), and\u002For TG ≥ 1.7 mmol\u002FL (150 mg\u002Fdl).\n  4. Fatty liver disease: Evidence of fatty liver confirmed by imaging within 3 months prior to screening or newly diagnosed at screening.\n  5. Obstructive sleep apnea syndrome.\n  6. Complaint of weight-bearing joint pain (during or within 3 months prior to screening).\n* Participants had a stable weight maintenance during the 3 months of dietary and physical activity prior to screening (participant-reported data acceptable) and no more than 5% weight fluctuation, which is calculated as: (maximum weight - minimum weight during the 3 months of dietary and exercise control prior to screening)\u002Fmaximum weight \\*100%.\n* Female participants of childbearing potential (including female partners of male participants) who have no plans to father a child or donate sperm from screening until 6 months after the last dose, and are willing to use at least one effective contraception.\n* Participants who well understand the study objectives, can communicate well with the investigator and to understand and comply with the requirements of this study, such as following the protocol medication and lifestyle intervention.\n\nExclusion Criteria:\n\n* Obesity secondary to underlying medical conditions or drug therapy, including but not limited to hypercortisolism (e.g., Cushing's syndrome), polycystic ovary syndrome, or obesity due to pituitary\u002Fhypothalamic damage; OR weight increase attributable to elevated non-fat mass (e.g., edema) at screening or randomization.\n* Have diabetes mellitus (including type 1 diabetes, type 2 diabetes, diabetes secondary to pancreatic injury, or other types of diabetes) or diagnosed with type 2 diabetes at screening\u002Frandomization, defined as HbA1c ≥ 6.5%, and\u002For fasting plasma glucose ≥ 7.0 mmol\u002FL (126 mg\u002FdL), and\u002For random plasma glucose ≥ 11.1 mmol\u002FL (200 mg\u002FdL).\n* One or more episodes of unexplained hypoglycemic events within 3 months prior to screening, defined as FPG \\\u003C 2.8 mmol\u002FL (50 mg\u002FdL) and\u002For presence of clinically significant hypoglycemic symptoms (symptoms of sympathetic activation \\[e.g., palpitations, anxiety, sweating, dizziness, hand tremble, hunger, etc.\\] and neuroglycopenic symptoms \\[e.g., altered consciousness, cognitive impairment, convulsions, and coma\\]).\n* History of psychiatric disorders, addictive disorders, or other conditions that may compromise the subject's ability to provide informed consent; OR history of unstable anxiety and\u002For depression that, in the investigator's judgment, remains clinically significant.\n* Have any lifetime history of a suicidal attempt or suicidal behavior.\n* History of major cardiovascular or cerebrovascular disease within 6 months prior to screening, defined as:\n\n  1. Acute myocardial infarction (MI), percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), heart valve repair\u002Freplacement, unstable angina, hemorrhagic stroke (stroke), ischemic stroke (including transient ischemic attack \\[TIA\\]).\n  2. Congestive heart failure of New York Heart Association (NYHA) class III or IV.\n* History of cardiac arrhythmias, including torsades de pointes, ventricular tachycardia, or second- or third-degree atrioventricular block.\n* Have a family or personal history of long QT syndrome, or family history of sudden death in first-degree relatives (parent, child, sibling) before the age of 40 years, and\u002For personal history of unexplained syncope within 1 year prior to screening.\n* History of gout within 6 months prior to screening.\n* History of proliferative retinal disease or maculopathy.\n* History of malignancy within 5 years prior to screening (except cured basal cell carcinoma of skin and cervical carcinoma in situ) or newly diagnosed malignancy at screening.\n* Have a family or personal history (parents, children, and siblings) of medullary thyroid cancer (MTC) or Multiple Endocrine Neoplasia Syndrome Type 2 (MEN2).\n* Abnormal thyroid function tests at screening (thyroid-stimulating hormone \\[TSH\\] \\> 6 mIU\u002FL or \\\u003C 0.4 mIU\u002FL) not adequately controlled by stable medication doses (defined as stable dosage for ≥3 months), untreated subclinical hypothyroidism (TSH \\\u003C10.0 mIU\u002FL with normal free T3 \\[FT3\\] and free T4 \\[FT4\\] levels) is permitted.\n* History of significant gastrointestinal disease (e.g., active ulcer) or gastrointestinal surgery (except appendectomy, cholecystectomy, or other gastrointestinal endoscopic procedures judged by the investigator as having no significant effect on gastrointestinal motility) or clinically significant gastric emptying abnormality (e.g., pyloric obstruction, gastroparesis) within 6 months prior to screening.\n* History of gastrointestinal disorders (e.g., chronic diarrhea, constipation, hemorrhoidal bleeding-whether resolved or not) deemed clinically significant by the investigator, OR acute exacerbation of hemorrhoids within 3 months prior to screening.\n* History of acute or chronic pancreatitis, or serum amylase or lipase \\> 1.5 × upper limit of normal (ULN) at screening.\n* Previous acute or chronic hepatitis, or symptoms and signs of any other liver disease other than non-alcoholic fatty liver disease, or any of the following, as determined by laboratory tests at screening:\n\n  1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × ULN.\n  2. Blood total bilirubin (TBIL) ≥ 1.5 × ULN.\n  3. Alkaline phosphatase (ALP) ≥ 3 × ULN.\n* Symptomatic cholecystitis or biliary diseases within 1 year prior to screening, except those with documented resolution of biliary stones following treatment.\n* Hypersensitivity or suspected hypersensitivity to glucagon-like peptide 1 receptor agonist (GLP-1RA) drugs or excipients.\n* History of drug abuse or dependence prior to screening.\n* High alcohol consumption within 3 months prior to screening (defined as an average daily consumption of more than 25 g of pure alcohol \\[equivalent to 750 mL of beer or 250 mL of wine or 50 g of liquor\\]).\n* Have current or history of treatment with medications that may cause significant weight gain within 3 months prior to screening, including but not limited to:\n\n  1. Approved\u002Funapproved marketed weight-loss drugs: orlistat, sibutramine hydrochloride, phentermine, phentermine-topiramate, naltrexone-amfebutamone, tirzepatide, semaglutide, liraglutide, beinaglutide, phendimetrazine, methylamphetamine, etc.\n  2. Glucagon-like peptide 1 receptor (GLP-1R) agonists or GLP-1R\u002Fglucagon receptor (GCGR) agonists or glucose-dependent insulinotropic polypeptide receptor (GIPR)\u002FGLP-1R agonists or GIPR\u002FGLP-1R\u002FGCGR agonists or dipeptidyl peptidase 4 (DPP-4) inhibitors.\n* History of bariatric surgery (excluding acupuncture\u002Fcupping\u002Fcatgut embedding for bariatric surgery, liposuction, and abdominoplasty performed \\>1 year prior to screening) or plans to undergo bariatric surgery or acupuncture\u002Fcupping\u002Fcatgut embedding, liposuction, abdominoplasty during the study period.\n* Symptomatic cholecystitis or biliary diseases within 1 year prior to screening, except those with documented resolution of biliary stones following treatment.\n* Major or medium-sized surgery, or severe trauma or serious infection within 3 months prior to screening, which, as assessed by the investigator, would preclude trial participation, or planned surgery during the study period (excluding outpatient procedures deemed by the investigator to have no impact on subject safety or trial outcomes).\n* History of organ transplant.\n* Use of any drug or food known to potently or moderately inhibit or induce cytochrome P450 3A4 enzyme (CYP3A4) and\u002For inhibit P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study.\n* Uncontrolled hypertension at screening, defined as systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg (verified prior to randomization. Blood pressure measurement should be performed after ≥5 minutes of seated rest, initial measurement followed by a second measurement after ≥1 minute, the final value will be the arithmetic mean of the two measurements (rounded to the nearest integer). If the difference between the first two measurements is ≥5 mmHg for either SBP or DBP, a third measurement shall be taken after ≥1 minute, the final value will be the arithmetic mean of all three measurements (rounded to the nearest integer).\n* Positive hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody or syphilis antibody at screening.\n* If any of the following laboratory abnormalities are present at screening:\n\n  1. Blood calcitonin ≥ 50 ng\u002FL.\n  2. Estimated glomerular filtration rate (eGFR) ≤ 60 mL\u002Fmin\u002F1.73 m2, calculated according to the CKD-EPI formula, as shown in Appendix VIII.\n  3. Poorly controlled severe dyslipidemia with TG ≥ 5.65 mmol\u002FL (500 mg\u002FdL) despite the use of conventional lipid-lowering drugs.\n  4. Prothrombin time-international normalized ratio (INR) \\> 1.5 × ULN.\n  5. Hemoglobin \\\u003C 110 g\u002FL (female) or \\\u003C 120 g\u002FL (male).\n* QTcF \\> 450 ms for male or QTcF \\> 470 ms for female at screening, measured after rest at least 5 min (repeat the measurement once and take the mean value \\[rounded off to integer\\]; the interval between measurements is 2 min±60 s).\n* Currently participating in any other clinical study, or if received any investigational product or medical devices within ≤ 3 months or 5 half-lives (t1\u002F2) prior to screening, whichever is longer.\n* Donation or loss of ≥ 400 mL of blood or transfusion within 3 months prior to screening.\n* Female participants during pregnancy or lactation.\n* The investigator, site personnel, and\u002For their immediate family members directly related to the study. An immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.\n* Participants who may be unable to complete this study for other reasons, or have other conditions that, as assessed by the investigator, will make the participant unsuitable for participation in this study, for example, the participant refuses to use only the weight-loss drugs specified in the protocol during the study.",{"count":315,"type":20},[198],"This is a 12 weeks, multicenter, randomized, double-blind, placebo, parallel-controlled Phase Ib trail comparing the efficacy and safety of MDR-001 tablet versus placebo as an adjunct to a reduced calorie diet and increased physical activity in subjects with overweight or obesity, and to explore the optimal dose selection to support the subsequent Pivotal trial.",[26],"2025-07-31",{"date":633,"type":37},"2025-08-08",{"date":635,"type":20},"2025-08-09",{"date":637,"type":20},"2025-10-30",{"name":639,"class":185},"MindRank AI Ltd"]