[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"overweight-or-obese\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:overweight-or-obese":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,81,111,133,160],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100632509","weight-loss-via-intelligent-guidance-in-patients-with-coronary-heart-disease-and-obesity-a-randomized-clinical-trial-100632509",false,"NCT07514611","Weight Loss Via Intelligent Guidance in Patients With Coronary Heart Disease and Obesity: a Randomized Clinical Trial","LIGHT-CHD","Inclusion Criteria:\n\n1. Age range: 18-65 years old .\n2. History of coronary heart disease confirmed by coronary angiography or coronary CTA, showing ≥50% stenosis in at least one major coronary artery (left main coronary artery, left anterior descending artery, left circumflex artery, right coronary artery); or a definite history of myocardial infarction, or prior coronary revascularization (PCI or CABG).\n3. BMI: Body Mass Index (BMI) ≥ 28 kg\u002Fm²\n4. Weight loss willingness: Has the intention to lose weight\n5. Smartphone proficiency: Able to use a smartphone.\n6. Daily living ability: Capable of performing basic activities of daily living independently.\n7. Informed consent: Voluntarily participates in the study, signs a written informed consent form, and is willing to cooperate with follow-up\n\nExclusion Criteria:\n\n1. Unstable angina pectoris or acute myocardial infarction occurring within the previous month;\n2. Comorbid endocrine or neurological diseases, cancer, or a history of bariatric surgery that affect body weight; or long-term use of medications that impact body weight;\n3. Comorbid diseases that affect exercise capacity, such as severe cardiopulmonary diseases or osteoarthritic conditions;\n4. Comorbid diseases that affect diet, such as severe mental disorders, bulimia or anorexia nervosa, or cognitive dysfunction;\n5. Significant liver or kidney dysfunction, defined as: glomerular filtration rate \\\u003C 60 ml\u002F(min·1.73m²) or undergoing dialysis; alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 3 times the upper limit of the normal range specified by the research center;\n6. Severe language, psychological, or physical disabilities that prevent participation in the protocol;\n7. Pregnant or lactating women, or individuals of childbearing potential who are unwilling\u002Funable to use effective contraceptive measures;\n8. Participation in other interventional clinical trials;\n9. Body weight change exceeding 5% within the past year;\n10. Patients with a habit of long-term high-intensity exercise(more than 2 sessions per week of high-intensity endurance training, or more than 3 sessions per week of moderate-intensity endurance training);\n11. Patients deemed unsuitable for participation in the study by the researchers.","ALL","18 Years","65 Years",{"count":20,"type":21},140,"ESTIMATED","INTERVENTIONAL",[24],"NA","Coronary Heart Disease (CHD) is an ischemic heart disease caused by coronary atherosclerosis, and it is the leading cause of death from cardiovascular diseases worldwide. Weight loss in obese patients can significantly improve metabolic indicators such as dyslipidemia and insulin resistance; therefore, weight loss may become a target for improving the prognosis of obese patients with coronary heart disease. This study is a multicenter, randomized controlled clinical trial aimed at evaluating the effect of software-based healthy weight loss guidance (personalized diet + exercise intervention) in obese patients with coronary heart disease. It is expected that 136 patients will be enrolled in hospitals including Guangdong Provincial People's Hospital, with a total study duration of 1 year.",[27,28],"CHD","Overweight or Obese",[27,30],"overweight or obese","RECRUITING","2026-05-08",{"date":34,"type":35},"2026-05-12","ACTUAL",{"date":37,"type":21},"2026-04-18",{"date":39,"type":21},"2028-12-31",{"name":41,"class":42},"Guangdong Provincial People's Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":65,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":43},"100619092","pistachio-snacking-and-metabolic-flexibility-100619092","NCT07340125","Pistachio Snacking and Metabolic Flexibility","Effects of Pistachio Snacking on Metabolic Flexibility in Healthy Overweight and Obese Adults","Inclusion Criteria:\n\n* Males and Females\n* Age: 25-45 years\n* Overweight or obese (BMI=25.0-34.9 kg\u002Fm²)\n* Poor sleep quality (Pittsburgh Sleep Quality Index ≥ 5)\n* Healthy (no diagnosed metabolic, cardiovascular, sleep, or other health condition that may significantly alter metabolism, sleep, or ability to participate in the exercise test)\n* Not meeting weekly physical activity recommendations (\\\u003C150 min moderate-intensity exercise, \\\u003C75 minutes of vigorous-intensity exercise, and \\\u003C2 days of strength training)\n* Not following a diet that is restrictive or eliminates certain food group\u002Ftypes\n\nExclusion Criteria:\n\n* Allergies to nuts, especially tree nuts\n* Has a pacemaker\n* Following a diet that is restrictive or eliminates certain food group\u002Ftypes\n* Self-repoted health or disease state that may influence study outcomes, including known metabolic or endocrine disorder (e.g. prediabetes, type 1 or type 2 diabetes, or polycystic ovary syndrome), cardiovascular diseases, neuromuscular disorders, musculoskeletal disorders; current or recent history of cancer\u002Fcancer treatment (within the past year)\n* History of gastrointestinal surgery, hysterectomy\n* For women: pregnant or thinking of becoming pregnant during the time of participation, pregnant within the last year, currently breastfeeding, or known to be perimenopausal",true,"25 Years","45 Years",{"count":55,"type":21},60,[24],"The purpose of this study is to evaluate the effects of pistachio snacking on metabolic flexibility (at rest, during exercise, and in post-exercise recovery) in healthy overweight and obese adults. Secondary goals include evaluating effects on changes in diet quality, sleep characteristics, physical activity, and hormonal health in women. In randomized order, participants will complete four days of pistachio snacking and four days of normal dietary habits (control). For both conditions, primary outcomes of resting substrate metabolism, metabolic flexibility during exercise, and post-exercise substrate metabolism will be measured pre-post intervention via indirect calorimetry. Secondary outcome of diet quality (kcal, carb, fat, protein) will be measured pre-post intervention via diet log. Exploratory outcomes of daily physical activity (steps, intensity), nightly sleep characteristics (quantity, quality, latency, efficiency), and daytime sleepiness and hunger.",[59,60,28,61,62,63,64],"Overweight (BMI > 25)","Obese But Otherwise Healthy Participants","Obese Patients (BMI ≥ 30 kg\u002Fm²)","Poor Sleep Quality","Healthy Participants","Physically Inactive",[66,67,68,69,70,71],"Pistachio","Tree Nuts","metabolic flexibility","metabolism","diet quality","snacking","2026-01-05",{"date":74,"type":35},"2026-01-14",{"date":76,"type":35},"2025-09-01",{"date":78,"type":21},"2026-12-31",{"name":80,"class":42},"University of South Carolina",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":43},"100615431","phase-2-tirzepatide-combined-with-cognitive-behavioural-therapy-cbt-for-adults-with-alcohol-use-disorder-aud-and-overweightobesity-oob-100615431","NCT07292519","Tirzepatide Combined With Cognitive-Behavioural Therapy (CBT) for Adults With Alcohol Use Disorder (AUD) and Overweight\u002FObesity (OOB)","Inclusion Criteria:\n\n1. Aged 21 to 75 years\n2. Meet DSM-5 criteria for alcohol use disorder (AUD) with at least moderate severity (≥4 symptoms in the past year)\n3. Have an average daily alcohol consumption of:\n\n   * ≥60g ethanol\u002Fday for men\n   * ≥40g ethanol\u002Fday for women (based on the 28 days prior to the baseline visit)\n4. Body mass index (BMI) ≥27 kg\u002Fm²\n5. Currently motivated to reduce or stop drinking but not engaged in formal AUD treatment\n6. Able and willing to attend weekly clinic visits and complete all study procedures\n7. Fluent in English and able to provide informed consent\n8. Stable housing situation (not transient or homeless)\n\nExclusion Criteria:\n\n1. Past-year DSM-5 diagnosis of another substance use disorder (except nicotine or mild cannabis use disorder)\n2. Recent (past 30 days) self-reported illicit drug use (excluding cannabis), or a positive urine drug screen for non-cannabis substances\n3. History of significant alcohol withdrawal, defined by:\n\n   * History of seizure, delirium tremens, or\n   * Hospitalisation for withdrawal, or\n   * CIWA-Ar score \\>9, or\n   * PAWS score \\>4 at screening\n4. Currently engaged in pharmacological or behavioral treatment for AUD, or prior engagement within the past 3 months\n5. History or current diagnosis of:\n\n   * Type 1 or Type 2 diabetes\n   * Diabetic complications (e.g. retinopathy)\n   * HbA1c ≥6.5% at screening\n6. Significant psychiatric illness, including:\n\n   * Current active suicidal ideation (per C-SSRS)\n   * Lifetime history of psychosis or bipolar disorder\n   * Unstable depression or anxiety interfering with daily functioning\n7. Chronic or acute pancreatitis\n8. Significant liver disease or abnormal liver function tests (ALT, AST, ALP, bilirubin \\>3× ULN)\n9. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type I\u002FII\n10. Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\n11. Recent significant weight loss (\\>5% of body weight in past 30 days)\n12. Use of any weight loss medication (e.g., orlistat, bupropion-naltrexone) or AUD medication (e.g., naltrexone, acamprosate, topiramate, varenicline) in the past 3 months\n13. Use of tirzepatide or any GLP-1 receptor agonist in the past 6 months\n14. Pregnant or breastfeeding, or not using effective contraception (females of childbearing potential)\n15. Inability to attend weekly visits due to work\u002Ftravel\u002Fschedule conflicts\n16. Participation in another clinical trial involving an investigational product\n17. Shared household with a current or past participant in this trial\n18. Scheduled for surgery requiring anaesthesia within 90 days of enrolment that would interfere with participation or follow-up\n19. History of muscle wasting, bone disorders (e.g. sarcopenia)\n20. Active gastrointestinal conditions that could interfere with treatment (e.g., severe GERD)\n21. Uncontrolled hypertension, recent heart attack or stroke (within 6 months)\n\n    Extra Exclusion criteria for Those Participants Agreeing to Participate in Neuroimaging \\& Psychophysiology Tasks:\n22. Presence of any MRI-incompatible metal implants or devices, including pacemakers, aneurysm clips, insulin pumps, or cochlear implants\n23. History of brain surgery or penetrating head trauma\n24. Prior occupation as a machinist, welder, or metal worker (due to risk of metal fragments)\n25. Non-removable piercings or dental hardware that would interfere with MRI\n26. History of claustrophobia likely to interfere with scanning compliance aa. Neurological disorders (e.g., epilepsy, multiple sclerosis) likely to confound neuroimaging data bb. Inability to lie still or tolerate MRI procedures cc. Patient weighting over 159kg (MRI scan limit) dd. Any other condition or medication judged by the investigator to preclude safe participation","21 Years","75 Years",{"count":90,"type":21},46,[92],"PHASE2","The investigators approach is to conduct a Phase II Double-Blind randomised controlled trial with individuals with co-occurring Alcohol Use Disorder and overweight\u002Fobesity (AUD-OOB) to receive either a sub-cutaneous injection of Tirzepatide (2.5 mg for 4 weeks followed by 5 mg for 4 weeks) or visually matched sham saline injection, in combination with a structured behavioural intervention (Take Control CBT Module). The primary aim of the study is evaluate the efficacy of the intervention on the number of heavy drinking days (defined as 5+ standard drinks for men, 4+ standard drinks for women) during the final month of treatment (weeks 5 to 8) compared to baseline. The secondary aim of the study is to assess treatment effects on alcohol related (e.g. number drinks consumed per day, abstinent days) and cardio-metabolic outcomes (e.g. body weight in kg, waist circumference, blood pressure, HbA1c, total cholesterol etc...), and summarise safety outcomes associated with use (e.g. frequency and severity of side effects, number of serious adverse events, treatment related discontinuations). The study will also include neurobiological assessments such as functional magnetic resonance imaging (fMRI) and lab-based psychophysiology to assess the impact of tirzepatide on change in brain activity and autonomic responses to alcohol and food cues.",[95,28,96],"Alcohol Use Disorder (AUD)","Comorbidities and Coexisting Conditions",[95,28,98,99,100],"Concurrent Treatment of AUD and overweight\u002Fobesity","Tirzepatide","Phase II Double-blind RCT","NOT_YET_RECRUITING","2025-12-15",{"date":104,"type":35},"2025-12-18",{"date":106,"type":21},"2026-01-15",{"date":108,"type":21},"2028-01-15",{"name":110,"class":42},"South West Sydney Local Health District",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":88,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":43},"100595757","phase-2-phase-ii-study-of-thdbh120-injection-in-overweight-or-obese-subjects-100595757","NCT07036601","Phase II Study of THDBH120 Injection in Overweight or Obese Subjects","A Multicenter, Randomized, Double-blind, Placebo-Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of THDBH120 Injection in Overweight or Obese Subjects","Inclusion Criteria:\n\n* Male or female patients 18 to 75 years of age, inclusive;\n* Have a BMI ≥ 28 kg\u002Fm² or 24 ≤BMI\\\u003C 28.0 kg\u002Fm² with at least 1 weight-related comorbidity at screening: prediabetes, hypertension, metabolic-associated fatty liver disease, dyslipidemia, weight-bearing joint pain, or obstructive sleep apnea syndrome;\n* Diet and exercise control for at least 3 months before screening visit, and less than 5% self-reported change within the last 3 months.\n\nExclusion Criteria:\n\n* History of diabetes;\n* History of obesity attributable to endocrine diseases, monogenic mutations, or drug-induced causes, such as hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism; or weight gain resulting from increased non-fat mass (e.g., edema);\n* Presence of uncontrolled hypertension at screening: systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg;\n* A 12-lead electrocardiogram (ECG) shows any of the following at screening: heart rate \\\u003C50 bpm or \\>100 bpm; QTcF prolongation (QT interval corrected by Fridericia's formula: QTc = QT\u002FRR\\^0.33; \\>450 ms for males, \\>470 ms for females); PR interval \\>200 ms; presence of long QT syndrome; second- or third-degree atrioventricular block; left bundle branch block; complete right bundle branch block; Wolff-Parkinson-White syndrome; or any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the clinical trial.",{"count":119,"type":21},276,[92],"To assess the efficacy and safety of THDBH120 injection compared with placebo in weight reduction in overweight or obese subjects after 26 weeks of treatment.",[28],"2025-06-16",{"date":125,"type":35},"2025-06-25",{"date":127,"type":35},"2025-01-06",{"date":129,"type":21},"2026-03-11",{"name":131,"class":132},"Tonghua Dongbao Pharmaceutical Co.,Ltd","INDUSTRY",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":51,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":156,"leadSponsor":158,"locationsCount":4},"100592438","phase-2-a-trial-with-emp16-in-preparation-for-late-phase-studies-100592438","NCT06993428","A Trial With EMP16 in Preparation for Late Phase Studies","A PilOt Dose-escalation Trial With EMP16 in Preparation for Phase III - the POEM Trial","POEM","Inclusion Criteria:\n\n* Willing and able to give written informed consent for participation in the trial.\n* Have experienced GI tolerability issues (defined as the occurrence of oily spotting, faecal incontinence and\u002For moderate\u002Fsevere diarrhoea as reported by the participant) in previous trials using EMP16 or have experienced corresponding GI tolerability issues using conventional orlistat, either in clinical trials or regular clinical treatment of obesity.\n* Males or females aged ≥18 years.\n* At the time of the screening visit, BMI ≥ 30 or ≥ 27 kg\u002Fm² in the presence of other risk factors based on participant interview e.g., hypertension (either or not treated with antihypertensive agents), glucose dysregulation (defined as elevated fasting glucose ≥6.1 mmol\u002FL or HbA1c \\>42mmol\u002Fmol), T2DM that is treated with lifestyle changes (no medication allowed), and\u002For dyslipidaemia (either or not treated with antihyperlipidemic agents). If indicated, plasma\u002Fserum total cholesterol, LDL, high-density lipoprotein (HDL), and\u002For triglycerides (TG) can be measured to verify eligibility as judged by the Investigator.\n* No clinically significant abnormalities regarding physical examination, vital signs, electrocardiogram (ECG), and laboratory values at the time of the screening visit, as judged by the Investigator.\n* Adequate renal function: creatinine \\\u003C1.5 times the upper limit of normal (ULN).\n* Adequate hepatic function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) \\\u003C2.5 times ULN and bilirubin \\\u003C1.5 times ULN.\n\nExclusion Criteria:\n\n* Regular use of any obesity medication within 1 month prior to Day 1 at the discretion of the Investigator.\n* Participants who are pregnant, who are currently breastfeeding, who intend to become pregnant within the period of the trial, or who gave birth within the 6 months preceding the screening visit.\n* T2DM treated with medication.\n* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial or influence the results or the participant's ability to participate in the trial including but not limited to:\n\n  * GI problems\u002Fdiseases, e.g. inflammatory bowel diseases and irritable bowel syndrome (IBS).\n  * Cholestasis.\n  * Chronical malabsorption syndrome.\n  * History of severe allergic, cardiac or hepatic disease.\n  * Previous GI surgery that might influence GI function significantly, such as previous bariatric surgery, and previous gallbladder surgery as judged by the Investigator.\n  * Vitamin B12 deficiency or other signs of achlorhydria. Potential participants with well-treated chronic diseases (e.g., celiac disease and lactose intolerance) may be included in the trial at the discretion of the Investigator.\n* Any clinically significant illness, medical\u002Fsurgical procedure or trauma within 4 weeks of the first administration of IMP.\n* Any planned major surgery within the duration of the trial.\n* Any use of drugs altering glucose metabolism and drugs used for diabetes (A10A and A10B) or drugs that are affected by, or that affect, orlistat and acarbose, within 2 weeks prior to the first administration of IMP.\n* Regular use of prescribed or non-prescribed medication within 2 weeks prior to the first administration of IMP as judged by the Investigator. Patients who are on stable treatment with anti-depressants (e.g., selective serotonin re-uptake inhibitors \\[SSRI\\]) for at least 2 months can be included at the discretion of the Investigator.\n* Untreated high blood pressure (systolic blood pressure \\>160 mmHg and diastolic blood pressure \\>100 mmHg at the screening visit).\n* Known hypersensitivity to any of the test substances.\n* Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.\n* History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.\n* Presence or history of drug abuse and\u002For use of anabolic steroids, as judged by the Investigator.\n* Positive screening result for drugs of abuse or alcohol at the screening visit.\n* Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and\u002For human immunodeficiency virus (HIV).\n* Plasma donation within 1 month prior to screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening.\n* Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical trial that included drug treatment within 3 months of the first administration of IMP in this trial. Participants who consented and screened but were not dosed in previous studies are not excluded.\n* The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.",{"count":142,"type":21},39,[92],"The goal of this clinical trial is to explore the impact of dietary fibre supplement in the form of Vi-Siblin® S (ispaghula seed coats), together with advice on proper healthy diet, on tolerability during dose-escalation of EMP16 in preparation for upcoming Phase III trials. It will also learn about the safety of EMP16. The main questions it aims to answer are:\n\n* How does the combination of EMP16 plus Vi-Siblin® S compare with the combination of conventional orlistat plus placebo dietary fibre supplementation on tolerability during dose-escalation\n* What medical problems do participants have when taking EMP16 plus Vi-Siblin® S? Researchers will compare EMP16 combined with Vi-Siblin® S or conventional orlistat combined with placebo (a look-alike substance that contains no Vi-Siblin ® S) dietary fibre supplement.\n\nParticipants will:\n\n* Take EMP16 combined with Vi-Siblin® S or conventional orlistat combined with placebo every day for 39 days\n* Come to one screening visit and then visit the clinic 6 times for checkups and tests\n* Keep an electronic diary to record specific GI tolerability event (GITE) such as oily spotting, faecal incontinence (including flatulence with discharge) and diarrhoea",[28,146],"Obesity and Overweight",[148,149,150,151],"Obesity","Dose-escalation","EMP16","Overweight","2025-05-20",{"date":154,"type":35},"2025-05-28",{"date":152,"type":21},{"date":157,"type":21},"2025-07-29",{"name":159,"class":132},"Empros Pharma AB",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":51,"sex":16,"minAge":17,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":43},"100582172","phase-1-a-study-to-evaluate-mwn109-injection-in-healthy-subjects-100582172","NCT06859853","A Study to Evaluate MWN109 Injection in Healthy Subjects","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MWN109 Injection in Healthy Subjects","Inclusion Criteria:\n\n1. Males or females, of any race, aged 18 to 50 years (inclusive) at Screening.\n2. \\[Part A: SAD\\] BMI of 19.0 to 40.0 kg\u002Fm2 (inclusive). \\[Part B: MAD\\] BMI of 27.0 to 45.0 kg\u002Fm2 (inclusive) with a minimum body weight of 50.0 kg for females and 55.0 kg for males.\n3. History of stable body weight for 3 months (defined as change \\\u003C 5%).\n4. Resting heart rate (supine) ≥ 45 bpm and ≤ 90 bpm with a single 12-lead ECG at Screening.\n5. Females of childbearing potential and males will agree to use contraception as detailed further in the protocol.\n6. Male participants must agree to refrain from sperm donation and females should refrain from ova donation from D-1 until 4 months after the last administration.\n7. Able to comprehend and willing to sign an ICF and to abide by all study requirements and restrictions.\n\nExclusion Criteria:\n\n1. Significant history or clinical manifestation of any cardiovascular, metabolic, allergic, endocrine, renal, hepatic, gastrointestinal, hematological, pulmonary, respiratory, dermatological, neurological, gynecological, psychiatric, disorders as determined by the investigator (or designee).\n2. History of pheochromocytoma or has uncontrolled blood pressure, as defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.\n3. History of insulinoma or has an event of blood glucose \\\u003C 2.8 mmol\u002FL within 1 year prior to Screening, or with ≥ 3 times of hypoglycemia symptoms within 3 months prior to Screening.\n4. History of febrile illness within 7 days prior to the first dose of IP or participants with evidence of active infection.\n5. Any of the following:\n\n   1. QTcF \\> 450 msec regardless of gender , confirmed by repeat measurement.\n   2. QRS duration \\> 110 msec confirmed by repeat measurement.\n   3. PR interval \\> 220 msec confirmed by repeat measurement.\n   4. Findings which would make QTc measurements difficult or QTc data uninterpretable.\n   5. History of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).\n6. Known history or family history of thyroid C-cell tumor\u002Fcarcinoma, multiple endocrine neoplasia syndrome type 2 (MEN2), thyroid dysfunction or thyroid hormone abnormality.\n7. History of diabetes mellitus Type I or II or clinical evidence of diabetes (e.g., hemoglobin A1c ≥ 6.5%, fasting blood glucose ≥ 126 mg\u002FdL \\[7.0 mmol\u002FL\\]) at Screening, non-fasting glucose ≥ 200 mg\u002FdL (11.1 mmol\u002FL) at Screening, or use of any hypoglycemic drugs during Screening or within 3 months prior to Screening\n8. History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury and other high-risk factors that may lead to pancreatitis.\n9. With any of following laboratory abnormality:\n\n   1. Elevation in serum amylase or lipase (\\> 1.5 × upper limit of normal \\[ULN\\]).\n   2. Have serum AST or ALT \\> 2 × ULN or total bilirubin \\>1.5 × ULN.\n   3. Have serum TG ≥ 5.65 mmol\u002FL (500 mg\u002FdL) at screening\n   4. Estimated glomerular filtration rate (eGFR) \\\u003C 90 mL\u002Fmin\u002F1.73m2.\n10. History of clinically significant abnormal gastric emptying (e.g., gastric outlet obstruction, gastroparesis), severe chronic gastrointestinal diseases (e.g., having active ulcer within 6 months prior to Screening, active gastritis or esophagitis, or uncontrolled gastroesophageal reflux disease, irritable bowel disease or severe inflammatory bowel disease).\n11. Long-term use of drugs directly affecting the gastrointestinal motility (including but not limited to mosapride, cisapride) or gastrointestinal surgery within 12 weeks prior to Screening and are inappropriate for participation in this clinical study as assessed by the Investigator.\n12. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or human immunodeficiency virus (HIV-1 and HIV-2) antibodies and p24 antigen.\n13. Any history of severe psychiatric disorder such as major depressive disorder, bipolar disorder, and schizophrenia, or history of suicidal ideation, behavior or attempts or other psychiatric disorder (within 2 years of Screening).\n14. Any suicidal ideation as identified by endorsement of (answered yes to) any of the items numbered 1-5 on the Columbia Suicide Severity Rating Scale (C-SSRS), if applicable.\n15. History of alcoholism or drug\u002Fchemical abuse within 1 year prior to D-1.\n16. Alcohol consumption of \\> 21 units per week for males and \\> 14 units per week for females, on average. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1\u002F6 gill (25 mL) of spirits.\n17. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) during the Screening period.\n18. Daily use of more than 10 cigarettes\u002Fday (on average), or 2 cigars\u002Fday (on average), or equivalent use of any tobacco product within 6 weeks prior to Screening.\n19. Females of pregnant or lactating, or those with a positive pregnancy test at Screening.\n20. Intolerance to venipuncture for blood sampling or history of fainting at blood drawing or sight of blood, unless deemed acceptable by the Investigator (or designee).\n21. History of severe Types I-IV hypersensitivity reactions, anaphylaxis, cytokine release syndrome, atopic individuals, or allergic reactions to multiple drugs. If the Investigator is considering enrolling a participant with drug allergies, agreement with the Medical Monitor should be sought.\n22. History of or suspected allergy or hypersensitivity to the investigational product or its components\n23. Use or intend to use any prescription medications\u002Fproducts other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee).\n24. Use or intend to use slow-release medications\u002Fproducts considered to still be active within 14 days prior to D-1, unless deemed acceptable by the Investigator (or designee).\n25. Use or intend to use any nonprescription medications\u002Fproducts including vitamins, minerals, and phytotherapeutic\u002Fherbal\u002Fplant-derived preparations within 7 days prior to D-1, unless deemed acceptable by the Investigator (or designee).\n26. Participants with a history of infectious diseases (which may affect the ability of the participant to participate in the study at the discretion of the Investigator), severe trauma, or major surgical operation within 4 weeks prior to Screening.\n27. Have been vaccinated within 4 weeks prior to Screening or plan to have vaccination during the study.\n28. Donation of blood or massive blood loss (\\> 450 mL) OR receipt of blood products within 12 weeks prior to Screening.\n29. Participation in a clinical study involving administration of an investigational agent\u002Fdevice or vaccine (new chemical entity) or having received a biological product within 12 weeks prior to Screening.\n30. Poor peripheral venous access.\n31. Are investigative site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.\n32. The presence of clinically significant physical examination, vital sign, drug, or ECG findings at Screening or baseline or laboratory findings at Screening that, in the opinion of the Investigator or Medical Monitor, may interfere with any aspect of study conduct or interpretation of results.\n33. Any skin condition and\u002For tattoo that may interfere with the evaluation of safety at the injection site.\n34. Are deemed unsuitable by the Investigator (or designee) for any other reason.","50 Years",{"count":169,"type":21},72,[171],"PHASE1","This study is a Phase1, randomized, double-blinded, and placebo-controlled study. In each cohort, enrolled participants will be randomized to receive either placebo or MWN109.",[28],"2025-04-11",{"date":176,"type":35},"2025-04-15",{"date":178,"type":35},"2025-03-17",{"date":180,"type":21},"2025-11-25",{"name":182,"class":132},"Shanghai Minwei Biotechnology Co., Ltd"]