[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"overweight-andor-obesity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:overweight-andor-obesity":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,51,89,119,146,169,196,224,247,284,312,344,370,412],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100644749","phase-1-semaglutide-delivered-epi-intradermally-by-microarray-patch-vx-201-versus-subcutaneous-administration-in-healthy-overweight-and-obese-participants-100644749",false,"NCT07673900","Semaglutide Delivered Epi-Intradermally by Microarray Patch (VX-201) Versus Subcutaneous Administration in Healthy Overweight and Obese Participants","A Randomized, Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Epi\u002FIntra-dermally Administered Semaglutide (VX-201) Compared to Subcutaneous Administration in Healthy Overweight and Obese Participants: Single and Multiple Dose Assessment","Inclusion Criteria:\n\n* To be eligible for study participation, all subjects must meet all the following inclusion criteria:\n\n  1. Medically healthy with no clinically significant medical history, vital sign, or coagulation results at Screening; chemistry, hematology, or urinalysis at Screening and Day -1 (SAD)\u002FDay 0 (MD) as deemed by the Investigator\n  2. Age 18 to 60 years, inclusive, at the time of Screening\n  3. Body mass index ≥25 to \\\u003C35 kg\u002Fm2 if participating in the SAD phase or ≥27 to \\\u003C40 kg\u002Fm2 if participating in the MD phase, at the time of Screening\n  4. Must be able to communicate well with the Investigator, understand and comply with the requirements of the study (including required confinement periods), and understand and provide written consent\n\nExclusion Criteria:\n\nAll subjects meeting any of the following criteria will be excluded from this study:\n\n1. Any disorder which in the investigator's opinion might jeopardize the subject's safety, evaluation of results, or compliance with the protocol\n2. Any of the following obesity or glycemia-related history:\n\n   1. Treatment with a GLP-1 receptor agonist within 90 days before screening\n   2. Treatment with any medication for the indication of obesity within the past 90 days before screening\n   3. A self-reported change in body weight \\> 5 kg (11 lb) within 90 days before screening irrespective of medical records.\n   4. Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device\n   5. HbA1c ≥ 6.5% as measured at screening\n   6. History of type 1 or type 2 diabetes mellitus\n3. Have a history of heart block, or a pulse rate (PR) interval \\>200 milliseconds (msec), or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study\n4. Have a significant history of or current cardiovascular (myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study medication, or interfering with the interpretation of data\n5. Estimated glomerular filtration rate \\\u003C80 mL\u002Fmin as determined by the Mosteller body surface area correction equation at Screening\n6. Have a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2\n7. Presence of acute pancreatitis within the past 90 days prior to the day of screening or history or presence of chronic pancreatitis\n8. Active malignancy or history of malignancy of any organ system (other than localized squamous cell or basal cell carcinoma of the skin that have been excised or resolved), treated or untreated, within the past 5 years\n9. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method\n10. Any prescription medications (except for hormonal contraception associated with inhibition of ovulation as described Exclusion 9) within 14 days of Screening\n11. Previously participated in another dose level group in the study\n12. Known hypersensitivity to semaglutide\n13. Known or suspected alcohol or drugs\u002Fchemical substance abuse within one year prior to the day of screening, or positive drug or alcohol screen results at Screening or Day-1\n14. Positive result for human immunodeficiency virus (HIV) or presence of actively replicating viral hepatitis due to hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at Screening\n15. Excessive tattoos, skin blemishes, or excessive hair near patch administration site\n16. Participation in any clinical study with an investigational or approved drug\u002Fdevice within 30 days or 5 half-lives (whichever is longer) before Screening or is planning to participate in another clinical study while enrolled in this study\n17. Donated or lost \\>200 mL of blood within 60 days before Day -1, donated plasma within 7 days before Day -1, or plans to donate blood or plasma during the study\n18. Is directly affiliated with the study at the study site or is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the study site, or is employed by Terrestrial Bio (that is an employee, temporary contract worker, or designee responsible for the conduct of the study) or is an immediate family member of an employee of Terrestrial Bio","ALL","18 Years","60 Years",{"count":20,"type":21},62,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","VX-201-101 is a first-in-human Phase 1 clinical study evaluating VX-201, a needle-free microneedle (MN) array patch (MAP) that delivers semaglutide through the skin as an alternative to subcutaneous (SC) injection.",[27],"Overweight and\u002For Obesity",[29,30,31,32,33,34,35,36,37],"first in human","Phase 1","randomized","single ascending dose","multiple dose","open label","pharmacokinetics","microarray patch","semaglutide","RECRUITING","2026-06-24",{"date":41,"type":42},"2026-06-29","ACTUAL",{"date":44,"type":42},"2026-06-15",{"date":46,"type":21},"2027-05-18",{"name":48,"class":49},"Terrestrial Bio, Inc.","INDUSTRY",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100639041","phase-3-a-study-to-learn-about-the-study-medicine-called-berobenatide-pf-08653944-in-people-with-overweight-or-obesity-100639041","NCT07595549","A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity","A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF-08653944 IN ADULTS WITH OVERWEIGHT OR OBESITY (VESPER-6)","Inclusion Criteria:\n\n* Aged ≥18 years.\n* BMI of: ≥30 kg\u002Fm2 or ≥27.0 kg\u002Fm2 to \\\u003C30.0 kg\u002Fm2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.\n\nExclusion Criteria:\n\n* Have a self-reported body weight change greater than 5% within 90 days prior to Screening.\n* Diagnosis of type 1 diabetes or any other form of diabetes other than T2D.\n* History of acute or chronic pancreatitis.\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).",{"count":59,"type":21},954,[61],"PHASE3","The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes.\n\nAbout 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe.\n\nPeople will take part in this study for about 20 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.",[64,27,65],"Obesity","Overweight",[67,68,69,70,71,72,73,74,65,64,75,76,77,78],"Overnutrition","Nutrition Disorders","Diabetes Mellitus, Type 2","Type 2 Diabetes","Body Weight","Diabetes Mellitus","Glucose Metabolism Disorders","Endocrine System Diseases","Nutritional and Metabolic Diseases","Signs and Symptoms","Pathological Conditions, Signs and Symptoms","Metabolic Diseases","2026-06-18",{"date":81,"type":42},"2026-06-23",{"date":83,"type":42},"2026-06-10",{"date":85,"type":21},"2028-06-21",{"name":87,"class":49},"Pfizer",9,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":50},"100642138","brief-inhibitory-training-for-eating---intervention-100642138","NCT07592728","Brief Inhibitory Training for Eating - Intervention","Inhibitory Control Training for Adolescents","BITE-I","Inclusion Criteria:\n\n* 14-17 years old\n* Have overweight or obesity (BMI-z≥85th percentile)\n* Have a smartphone\n* Can read and speak English\n* Interest in improving one's diet.\n\nExclusion Criteria:\n\n* Not currently in eating disorder or weight loss treatment or receiving pharmacological\u002Fsurgical treatment for obesity in the past four weeks\n* Not meeting criteria for atypical anorexia nervosa or bulimia nervosa","14 Years","17 Years",{"count":100,"type":21},36,[102],"NA","The purpose of this study is to conduct a proof-of-concept intervention of daily inhibitory control (IC) training.\n\nAim 1 is to examine the feasibility, acceptability, and barriers of an IC training EMI in adolescents' daily life.\n\nAim 2 is to evaluate the efficacy of IC training for modifying the hypothesized intervention mechanism: food-related IC and eating regulation.\n\nIn the study, participants will:\n\nComplete questionnaires and cognitive tasks Receive a short nutrition education Complete three weeks of daily brain games on your phone",[27],[106,107,108,109],"obesity","adolescent","nutrition","eating behavior",{"date":111,"type":42},"2026-06-17",{"date":113,"type":42},"2026-05-01",{"date":115,"type":21},"2027-03-10",{"name":117,"class":118},"George Mason University","OTHER",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100642828","phase-2-a-study-of-pf-08653945-and-pf-08653944-in-adults-with-overweight-or-obesity-solis-1-100642828","NCT07575932","A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity (SOLIS-1)","A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, DOSE RANGING, DOSE-FINDING, UMBRELLA STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08653945 AND PF-08653944, ALONE OR IN COMBINATION, IN ADULTS WITH OVERWEIGHT OR OBESITY (SOLIS-1)","SOLIS-1","Inclusion Criteria:\n\nEligible participants for this study include:\n\n* adults aged 18 years or older with\n* obesity (BMI of 30.0 kg\u002Fm2 to 50.0 kg\u002Fm2) or with\n* overweight (BMI of 27.0 kg\u002Fm2 to \\\u003C30.0 kg\u002Fm2) who also have at least 1 prespecified weight-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, or obstructive sleep apnea), at the screening visit.\n\nExclusion Criteria:\n\nParticipants who are not eligible include those with diabetes mellitus, a body weight change of \\>5% or use of weight loss medications in the 12 weeks prior to screening, a history of or plan for surgical treatment for obesity, and those who are unable or unwilling to comply with contraceptive requirements or are pregnant or lactating.",{"count":128,"type":21},872,[130],"PHASE2","This study is being done to learn about the safety and effects of the study drugs, PF-08653945 and PF-08653944, when given alone or together for weight loss, compared to a placebo (a dummy drug that has no active ingredient in it).",[65,64,27,133,67,68,75,71],"Overweight or Obesity",[67,68,75,71,64,65,135,136,137],"GLP-1RA","Amylin","DACRA","2026-06-09",{"date":83,"type":42},{"date":141,"type":42},"2026-05-11",{"date":143,"type":21},"2028-01-05",{"name":87,"class":49},48,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},"100623747","phase-3-a-study-to-learn-about-the-study-medicine-pf-08653944-in-people-with-obesity-or-overweight-and-type-2-diabetes-t2d-100623747","NCT07400653","A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)","EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY-BIASED ULTRA LONG-ACTING GLP-1RA, IN PEOPLE WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES: A PHASE 3, MULTI-CENTER RANDOMIZED PLACEBO-CONTROLLED TRIAL (VESPER-5)","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form (ICF)\n* Male or female adults, aged ≥18 years\n* Have a BMI at Screening of ≥27.0 kg\u002Fm2\n* Have T2DM for at least 6 months before Screening based on participant reported history or documentation of the disease diagnostic criteria\n* Have HbA1c value between ≥6.5% (48 mmol\u002Fmol) and ≤10.0% (86.0 mmol\u002Fmol) at Screening with stable therapy for at least 90 days prior to Screening\u002FVisit 1. T2DM may be treated with:\n\n  --Diet and exercise alone or in combination with: Any oral antidiabetic therapy per local labeling EXCEPT DPP-4 inhibitors. Participant may NOT be on GLP-1 agonists or insulin\n* Participants must be motivated and willing to:\n\n  * Self-inject study medication (or be aided by caregiver if needed),\n  * Perform finger-stick glucose monitoring as required.\n* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.\n\nExclusion Criteria:\n\n* Female who is breastfeeding, or who is pregnant\n* Unwilling or unable to follow contraceptive requirements\n* Diagnosis of Type 1 diabetes, or any other types of diabetes except T2DM.\n* Severe hypoglycemia and\u002For hypoglycemia unawareness within the 6 months prior to Screening\n* Poorly controlled hypertension\n* Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \\>1 year prior to screening)\n* Have taken within 3 months prior to randomization, medications (prescribed or over-the counter) intended to promote weight loss\n* Are receiving or have received within 3 months prior to screening chronic (\\>2 weeks or 14 days) systemic glucocorticoid therapy",{"count":154,"type":21},999,[61],"The purpose of this clinical study is to learn about the safety and effects of the study medicine to help adults with obesity or overweight and type 2 diabetes lose weight. Being overweight or obese means carrying too much body weight. Type 2 diabetes is a condition where there is too much sugar in the blood.\n\nThe study medicine is given by a shot under the skin in the belly area. The participants will be trained to do this at home once every week.\n\nAbout 660 out of 1000 adults will also receive the study medicine and about 330 out of 1000 adults will receive placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help us assess if the study medicine is safe and effective.\n\nPeople will take part in this study for about 21 months. During this time, they will have about 14 study visits at the site and 5 over the phone.",[64,27,65,158,70],"Diabetes, Type 2",[67,68,75,71,76,77,72,73,78,74,65,64,69],"2026-05-14",{"date":162,"type":42},"2026-05-18",{"date":164,"type":42},"2026-02-24",{"date":166,"type":21},"2028-05-16",{"name":87,"class":49},183,{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":181,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":50},"100638474","optimization-of-dietary-adherence-in-a-mobile-weight-loss-intervention-100638474","NCT07582536","Optimization of Dietary Adherence in a Mobile Weight Loss Intervention","Optimizing Dietary Adherence in a Mobile Behavioral Weight Loss Intervention for Adults","Inclusion Criteria:\n\n* BMI 25-50 kg\u002Fm2 at baseline\n* Own a smartphone with an active data and text messaging plan\n* English-speaking and writing\n* Willing to be randomized to any of the additional treatment components\n\nExclusion Criteria:\n\n* Lost 5% or more of body weight (and kept it off) in the last 3 months\n* Past diagnosis of or receiving treatment for a clinically diagnosed eating disorder (anorexia nervosa or bulimia nervosa)\n* Current symptoms of alcohol or substance dependence\n* Currently pregnant, pregnant within the past 6 months, currently breastfeeding, or planning to become pregnant within the next 6 months\n* Untreated thyroid disease or any changes (type or dose) in thyroid medication in the last 6 months\n* Hospitalization for depression or other psychiatric disorders within the past 12 months\n* History of psychotic disorder or bipolar disorder\n* Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study\n* Currently using prescription medications with known effects on appetite or weight (e.g., oral steroids, weight loss medications), except individuals on a stable dose of SSRIs for 3 months\n* Current use of bone acting medications (e.g., raloxifene, calcitonin, parathyroid hormone during the past year, PTH-analogues \\[e.g., teriparatide, abaloparatide\\], sclerostin inhibitors (romosozumbab), RANK ligand inhibitors (denosumab) or bisphosphonates during the last two years\n* Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4)\n* Report a health condition for which the program's dietary and physical activity recommendations would be unsafe, including hospitalization for heart failure, myocardial infarction or stroke in the past year, chronic kidney disease stage IV or V, liver failure or cirrhosis, chronic obstructive pulmonary disease on oxygen or requiring steroids, osteoporosis on medication, sarcopenia, history of fragility fractures, or dementia\n* Other health problems that may influence the ability to walk for physical activity or be associated with unintentional weight change, including current cancer diagnosis, cancer treatment within the past 5 years or tuberculosis\n* Previous surgical procedure for weight loss or planned weight loss surgery in the next year\n* Another member of the household is a participant or staff member on this trial\n* Ability to provide consent (4 items adapted from the UBACC \\[University of California, San Diego Brief Assessment of Capacity to Consent\\])\n* Reason to suspect that the participant would not adhere to the study intervention\n* Does not live in the United States\n* Cannot have participated in a research study conducted by UNC Weight Research Program in the past 2 years\n\nIndividuals endorsing joint problems, current treatment for hypertension or hyperlipidemia, or osteoporosis diagnosis not on medication will be required to obtain written physician consent to participate.",{"count":177,"type":21},580,[102],"The goal of this study is to test multiple individual treatment components added to a 6-month standard mobile behavioral weight loss program that are intended to help participants follow dietary recommendations and meet their dietary goals more often. The four components to be studied include switching dietary tracking methods, receiving access to a goal planning tool, receiving additional personalized text messages, and receiving three sessions with a health coach. The study will identify the best combination of these additional treatments for improving total number of weeks in the program that participants meet their dietary goals.",[27],[182,183,184,185],"behavioral intervention","weight loss","mHealth intervention","dietary recommendations","NOT_YET_RECRUITING","2026-05-13",{"date":189,"type":42},"2026-05-15",{"date":191,"type":21},"2027-03",{"date":193,"type":21},"2029-10",{"name":195,"class":118},"UNC Lineberger Comprehensive Cancer Center",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":50},"100637739","effects-of-whole-body-high-intensity-interval-training-on-fitness-in-overweight-adults-100637739","NCT07582718","Effects of Whole-Body High-Intensity Interval Training on Fitness in Overweight Adults","Effects of a Whole-body High-intensity Interval Training on Cardiorespiratory Fitness, Musculoskeletal Fitness, Body Composition and Blood Parameters in Overweight Subjects","WB-HIIT","Inclusion Criteria:\n\n* Adults aged 18 to 55 years.\n* Body mass index (BMI) between 25 and 35 kg\u002Fm².\n* Able to provide written informed consent.\n* Able to safely participate in high-intensity interval training.\n* For participants with BMI \\> 30 kg\u002Fm²: medical clearance from their general practitioner.\n\nExclusion Criteria:\n\n* BMI \\\u003C 25 or \\> 35 kg\u002Fm².\n* Presence of any chronic medical condition other than overweight\u002Fobesity.\n* Known cardiovascular, metabolic, respiratory, or musculoskeletal disease that contraindicates high-intensity exercise.\n* Pregnancy.\n* Inability to perform exercise testing or complete the WB-HIIT program.\n* Any condition judged by investigators to interfere with participation or data interpretation.","55 Years",{"count":206,"type":21},40,[102],"This study aims to evaluate the effects of a supervised whole-body high-intensity interval training (WB-HIIT) program on physical fitness and health outcomes in adults with overweight and obesity. WB-HIIT is a practical and time-efficient training modality based on body-weight exercises performed at high intensity with short recovery intervals. It may offer an accessible approach for improving health in individuals with excess body weight.\n\nParticipants aged 18 to 55 years with a body mass index (BMI) between 25 and 35 kg\u002Fm² will take part in a supervised 10-week WB-HIIT program, performed in small groups and led by trained exercise professionals. Before and after the intervention, participants will undergo assessments including DXA-based body composition analysis, fasting blood sampling, muscular strength testing, a Chester step test, a maximal graded treadmill exercise test with gas-exchange analysis to determine VO₂peak, and functional evaluations (chair-stand, arm-curl, and 6-minute walk test). Physical activity and dietary intake will also be recorded.\n\nThe primary objective of the study is to assess whether WB-HIIT improves cardiorespiratory fitness (VO₂peak) in adults with overweight. Secondary objectives include evaluating changes in muscular strength, body composition, metabolic markers, and functional capacity.\n\nThe results may help determine whether an equipment-free WB-HIIT program can serve as an effective and accessible training approach for improving health and physical fitness in adults with overweight and obesity.",[27],[65,211,212,213,214,215,216],"Cardiorespiratory Fitness","Body Composition","Muscular Strength","Whole-Body HIIT","Body-Weight Exercise","Metabolic health",{"date":187,"type":42},{"date":219,"type":42},"2022-11-09",{"date":221,"type":21},"2026-06",{"name":223,"class":118},"Université Libre de Bruxelles",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":231,"sex":16,"minAge":17,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":50},"100632019","phase-1-a-study-to-learn-about-the-effect-of-study-medicine-called-pf-08653944-on-how-quickly-the-stomach-empties-its-content-in-healthy-adults-with-overweight-or-obesity-100632019","NCT07508241","A Study to Learn About the Effect of Study Medicine Called PF-08653944 on How Quickly the Stomach Empties Its Content in Healthy Adults With Overweight or Obesity","A PHASE 1, OPEN-LABEL, MULTIPLE DOSE STUDY TO INVESTIGATE THE IMPACT OF PF 08653944 ON GASTRIC EMPTYING IN ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY","Inclusion Criteria:\n\n* Adults ≥18 years at screening, male or female, generally healthy as determined by medical history, physical examination, laboratory tests, and ECG.\n* Body mass index (BMI) 27-45 kg\u002Fm² and body weight \\>50 kg (110 lb).\n* Participants with overweight or obesity\n\nExclusion Criteria:\n\n* History or presence of clinically significant medical conditions, including but not limited to:\n\n  --Cardiovascular, hepatic, renal, pulmonary, endocrine, hematologic, neurologic, gastrointestinal (including pancreatitis or gallbladder disease), or significant psychiatric disorders.\n* Any form of diabetes, HbA1c ≥6.5%, or fasting plasma glucose ≥126 mg\u002FdL.\n* Prior exposure to a GLP-1 receptor agonist within 90 days before first dose, or prior participation in a study with PF-08653944.",true,"99 Years",{"count":234,"type":21},20,[24],"This study looks at how a study medicine called PF-08653944 affects how quickly the stomach empties food after eating. It is being done in adults who are overweight or have obesity.\n\nParticipants will receive the study medicine for a short period, and doctors will measure how the medicine moves through the stomach and monitor safety. The goal is to better understand how this medicine works in the body and to check for any side effects.\n\nThe information from this study may help researchers plan future studies of this medicine.",[64,27,65,238],"Drug Interaction","2026-04-20",{"date":241,"type":42},"2026-04-23",{"date":243,"type":42},"2026-03-31",{"date":245,"type":21},"2027-01-27",{"name":87,"class":49},{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":231,"sex":255,"minAge":256,"maxAge":18,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":263,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":50},"100631491","effects-of-a-6-months-fiber--and-polyphenol-rich-diet-on-brain-inflammatory-processes-in-perimenopausal-women-living-with-overweight-or-obesity-100631491","NCT07501377","Effects of a 6-months Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Perimenopausal Women Living With Overweight or Obesity","Effects of a Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Obesity","INFLAME","Inclusion Criteria:\n\n* STRAW+10 -1 or -2\n* BMI \\> 25 or WHR \\>= 0.85\n* hsCRP \\> 1 mg\u002Fl\n* no MRI contra-indication\n* written informed consent\n\nExclusion Criteria:\n\n* occurrence of a clinically relevant psychiatric disease in the last 12 months (e.g., depression, substance abuse, eating disorder, schizophrenia)\n* type 1 diabetes\n* previous bariatric\u002Fgastric surgery\n* pregnancy or breastfeeding woman\n* severe untreated disease, cancer treatment last 12 months, any chronic gastric tract disease (IBS, Morbus Crohn, Heliobacter pylori Infection etc.) or any chronic inflammatory disease\n* Polycystic ovary syndrome, total ovarectomy\n* Intake of antibiotics in past 3 months, intake of inulin (\\>5g\u002Fday) or polyphenol supplementation (\\>50mg\u002Fday) in past 3 months","FEMALE","35 Years",{"count":258,"type":21},120,[102],"People living with obesity have a higher risk of late-life cognitive decline and developing dementia. In women, the risk of cognitive decline may further raise during the menopausal transition, a period of substantial hormonal and metabolic changes.\n\nRecent studies suggest that a healthy diet could help to prevent neurocognitive disorders by reducing inflammatory processes in the body and brain. Emerging evidence further indicates that the gut-brain axis and the intestinal microbiome play a crucial role in mediating this effect, through metabolic, immune, neuronal and vascular routes. Modifying the gut microbiota may thus counteract the heightened systemic inflammation seen in obesity and during menopausal transition to eventually benefit brain health.\n\nSpecifically, plant-based nutirents, such as fibre and polyphenols, have microbiome-changing, anti-inflammatory and neuroprotective properties that may slow brain aging and neuro-inflammation. However, evidence from human interventional studies and knowledge on the underlying mechanisms remain scarce.\n\nThis randomized controlled trial will therefore test whether altering gut bacteria through six months of daily intake of a personalized \"polybiotic\" dietary formula, compared to placebo, improves markers of brain health in women during the perimenopausal transition that are living with overweight or obesity. We plan to enroll 120 women aged 35-60 with overweight\u002Fobesity and elevated inflammatory blood markers, randomized to: intervention (7.5 or 15 g inulin, plus 200 mg resveratrol and 320 mg quercetin per day in powder form with main meals) or control (isocaloric maltodextrin). Exclusions include type 1 diabetes, current psychiatric\u002Fgastrointestinal disorders, and magentic resonance imaging (MRI) contraindications.\n\nBefore and after 26 weeks, participants will undergo brain MRI to assess inflammation-related brain markers, neuropsychological testing, anthropometric measurements, they will fill in a set of questionnaires and donate stool and blood. Gut bacteria will be profiled by next-generation sequencing; metabolites will be measured in blood and stool. The primary outcome is a proxy of neuroinflammation in the white matter assessed using diffusion-weighted MRI. Secondary analyses will examine blood-brain-barrier permeability and other functional and structural MRI measures, including MR spectoscropy. Mechanistic links among changes in inflammatory markers, microbiota composition, and short-chain fatty acids will be explored using path and network models.\n\nThis study may help to develop novel prevention and treatment strategies to mitigate obesity-related cognitive decline via the gut-brain axis.",[27,262],"Perimenopausal Women",[264,106,265,266,267,268,269,270,271,272,273,274],"neuroinflammation","overweight","menopausal transition","gut-brain axis","diet","diffusion-weighted MRI","cognitive decline","brain aging","MR spectroscopy","prevention","open science","2026-03-26",{"date":277,"type":42},"2026-03-30",{"date":279,"type":42},"2026-03-19",{"date":281,"type":21},"2030-12-31",{"name":283,"class":118},"Max Planck Institute for Human Cognitive and Brain Sciences",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":231,"sex":16,"minAge":291,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":294,"briefSummary":295,"conditions":296,"keywords":299,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":50},"100605242","family-based-nutrition-intervention-to-prevent-overweight-and-obesity-in-school-age-children-100605242","NCT07159971","Family-Based Nutrition Intervention to Prevent Overweight and Obesity in School-Age Children.","Family-based Intervention Model to Prevent Childhood Obesity Among Schoolage Children in Sonora, Mexico.","Inclusion Criteria:\n\n* Families of children between 5 and 9 years old.\n* Children without any medical or nutritional treatment for obesity.\n* Children classified as normal weight, overweight, or obese based on WHO (Z-score: height for age and BMI for age).\n* Offspring of mothers aged between 18 and 45 years at delivery.\n* Term infants from normoevolutive pregnancies without maternal comorbidities.\n* Families who have a cell phone with internet access and an installed camera.\n\nExclusion Criteria:\n\n* Children who are currently suffering from a pathology that requires medication or special treatment\n* Mothers\u002FFathers\u002FGuardians who are currently suffering from a pathology that requires medication or special treatment.\n* Children who have a physical\u002Fmental impairment to perform physical activities.\n* Children from surrogate mothers who have presented at least 2 of the 11 DSM-5 criteria for substance use disorder (alcohol, tobacco, cannabis, or other illegal drugs) before or during the participating child's gestation.\n* Children from multiple pregnancies.\n* Parents who do not own a smartphone compatible with the app will be excluded from this study (i.e., version 5.0 or higher for Android).","5 Years","9 Years",{"count":206,"type":21},[102],"This proposal aims to enhance the well being of schoolchildren and their families through a mobile application and multidisciplinary intervention model grounded in authoritative parenting principles and social cognitive theory.",[27,297,298],"Children - Malnutrition","Preventing Malnutrition",[64,300,301,302,303],"Children","mHealth","Intervention","Family-base",{"date":305,"type":42},"2026-03-24",{"date":307,"type":42},"2025-06-30",{"date":309,"type":21},"2027-12-01",{"name":311,"class":118},"Claudia Teresa Tovar Palacio",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":320,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":324,"conditions":325,"keywords":329,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":343},"100611220","iwaist-trial-ercg-endoscopic-radial-compression-gastroplasty-vs-optimized-lifestyle-intervention-for-weight-loss-100611220","NCT07237750","iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss","iWAIST Trial: A Multicenter, Single-Blind, Randomized, Sham-Controlled Trial of Endoscopic Radial Compression Gastroplasty (ERCG) Plus Optimized Lifestyle Intervention for Weight Management in Chinese Adults With Overweight or Mild-to-Moderate Obesity","iWAIST-RCT","Inclusion Criteria:\n\n* Asian adults aged 18-65 years.\n* BMI 24.0-37.4kg\u002Fm²(Chinese standard)。\n* Failed prior conservative weight loss attempts ≥2 months。\n* Willingness to comply with follow-up.\n* Provided written informed consent.\n\nExclusion Criteria:\n\n* Prior gastrointestinal surgery with clinically relevant sequelae.\n* Active or clinically significant gastrointestinal disease, including inflammatory conditions (e.g., esophagitis, Barrett's esophagus, Crohn's disease), peptic ulcer disease (gastric\u002Fduodenal ulcer), or neoplastic lesions.\n* Any condition associated with an increased risk of upper gastrointestinal bleeding.\n* Hiatal hernia \\>2 cm or severe\u002Frefractory gastroesophageal reflux disease (GERD); acid reflux requiring ≥2 medications for symptom control.\n* Esophageal\u002Fpharyngeal structural abnormalities that may impede endoscope passage (e.g., stricture, diverticulum).\n* Achalasia or other severe esophageal motility disorder.\n* Severe coagulopathy.\n* Insulin-dependent diabetes mellitus.\n* Chronic abdominal pain.\n* Gastrointestinal motility disorder (e.g., gastroparesis).\n* Hepatic impairment or cirrhosis.\n* Severe or uncontrolled psychiatric illness.\n* Alcohol abuse or substance dependence.\n* Unwilling to participate in a physician-supervised diet\u002Fbehavior modification program and\u002For unwilling to comply with routine follow-up.\n* Daily regular use of NSAIDs, anticoagulants, or other gastric-irritating medications.\n* Unable or unwilling to take proton pump inhibitor (PPI) therapy as prescribed during the treatment period.\n* Known or suspected hypersensitivity to any material\u002Fcomponent of the study system.\n* Pregnant or breastfeeding.\n* Severe cardiopulmonary disease or other serious systemic\u002Forganic disease.\n* Positive Helicobacter pylori (H. pylori) test.\n* Use of time-critical medications potentially affected by altered gastric emptying (e.g., antiepileptics, antiarrhythmics).\n* Current systemic corticosteroids, immunosuppressants, or opioid analgesics.\n* Use of any weight-loss medication within the past 3 months or current use.\n* Prior use of any intragastric device.\n* Participation in a weight-affecting clinical trial within the past 6 months.\n* Symptomatic congestive heart failure, clinically significant arrhythmia, or unstable coronary artery disease.\n* Clinically significant respiratory disease.\n* Autoimmune connective tissue disease.\n* Life expectancy \\\u003C1 year or severe renal\u002Fhepatic\u002Fpulmonary or other serious medical illness.\n* Known genetic or endocrine cause of obesity (e.g., hypothyroidism, Prader-Willi syndrome) or other endocrine disease known to affect body weight.\n* Eating disorder (e.g., night eating syndrome, bulimia nervosa, binge eating disorder, compulsive eating).","65 Years",{"count":322,"type":21},216,[102],"Obesity and overweight are rising in Chinese populations, where metabolic risks begin at lower BMI thresholds than in Western cohorts. Many individuals with overweight or mild-to-moderate obesity are ineligible or unwilling to undergo bariatric surgery due to invasiveness and risk. Endoscopic bariatric and metabolic therapies offer minimally invasive alternatives but vary in complexity, cost, and safety profiles. Investigators developed a sutureless endoscopic procedure, Endoscopic Radial Compression Gastroplasty (ERCG), which reduces gastric volume by apposing gastric walls using a clip-and-loop system. This randomized controlled trial evaluates the efficacy and safety of ERCG versus an optimized lifestyle intervention in Asian adults with BMI 24.0-37.4 kg\u002Fm² who have not succeeded with conservative measures. Preliminary studies suggest ERCG can achieve approximately 12% total body weight loss (TBWL) at 3 months. The primary endpoint is percent TBWL at 3 months; secondary outcomes include changes in BMI, metabolic parameters, quality of life, and adverse events. Results are expected to inform the role of ERCG as a safe, effective, and scalable option between conservative care and bariatric surgery.",[27,326,327,328],"Metabolic Syndrome","Nonalcoholic Fatty Liver Disease","Chinese",[330,331,332,65,333,328,64],"Endoscopic gastroplasty","Endoscopic bariatric therapy","Weight loss","Gastric volume reduction","2026-03-11",{"date":336,"type":42},"2026-03-13",{"date":338,"type":42},"2026-03-01",{"date":340,"type":21},"2027-05-31",{"name":342,"class":118},"Liu Yan",2,{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":231,"sex":16,"minAge":17,"maxAge":320,"enrollmentInfo":351,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":50},"100611637","phase-1-a-phase-ibiia-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-oral-ecnoglutide-tablets-in-chinese-participants-with-overweight-or-obesity-100611637","NCT07243171","A Phase Ib\u002FIIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity","A Multicenter, Multiple-dose Escalation, Randomized, Double-blind, Placebo-controlled Phase Ib\u002FIIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity","Inclusion Criteria:\n\n1. At the time of informed consent, with BMI in the range of 24.0 to 35.0 kg\u002Fm2 (including the threshold), body weight \\>60.0 kg for male, and weight \\>50.0 kg for female;\n2. Self-declaration of body weight change \\\u003C5% within 3 months prior to informed consent ;\n\nExclusion Criteria:\n\n1. Diagnosis of overweight or obesity due to endocrine disorders , such as Cushing's syndrome;\n2. Diagnosis of other endocrine disorders with clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging shows TI-RADS≥ class 3), thyroid cancer, or personal or family history of type 2 multiple endocrine tumor syndrome (MEN2), etc.\n3. Diagnosis of cardiovascular or cerebrovascular diseases with clinical significance within 6 months prior to screening, including but not limited to acute stroke, acute coronary syndrome, heart failure, arrhythmia, etc.\n4. Diagnosis of severe gastrointestinal diseases, including but not limited to inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, dyspepsia, diabetic gastroparesis, diabetic diarrhea, clinical gastric emptying abnormalities (such as pyloric obstruction), etc.\n5. History of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period;\n6. HbA1c ≥6.5% or fasting blood glucose ≥7.0 mmol\u002FL, or OGTT 2-hour blood glucose ≥11.1 mmol\u002FL, at screening;\n7. Clinical laboratory test results with clinical significance",{"count":352,"type":21},84,[24,130],"The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral ecnoglutide tablets in Chinese participants with overweight or obesity",[27,356],"Weight Management",[358,359,106,265,360],"ecnoglutide","glucagon-like peptide-1 (GLP-1)","weight management","2026-01-27",{"date":363,"type":42},"2026-01-28",{"date":365,"type":42},"2025-11-18",{"date":367,"type":21},"2026-11-22",{"name":369,"class":49},"Hangzhou Sciwind Biosciences Co., Ltd.",{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":231,"sex":16,"minAge":378,"maxAge":379,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":382,"briefSummary":383,"conditions":384,"keywords":392,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":50},"100599548","norwegian-mental-illness-heart-health-study-100599548","NCT07085923","Norwegian Mental Illness Heart Health Study","Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness","NORMI-Heart","Inclusion Criteria:\n\n* Diagnosis of F20-29 (schizophrenia spectrum) or F31 (bipolar affective disorder)\n* Current use of antipsychotic medication (first- or second generation) or lithium\n* Body Mass Index \\> or = 27 kg\u002Fm\\^2\n\nExclusion Criteria:\n\nPsychiatric condition:\n\n* Inability to provide informed consent\\*\n* Acute psychiatric crisis\\*\n* Significant cognitive impairment\\* \\*These criteria will be evaluated and confirmed by the participant's primary mental health care provider before enrollment\n\nMedication initiated during the intervention period:\n\n* GLP-1 receptor agonists\n* Antihypertensive medication\n* Antidiabetic medication\n* Lipid-lowering medication\n\nAlcohol consumption:\n\n-More than 14 units per week (men) or more than 7 units per week (women)\n\nSomatic conditions:\n\n* Type 1 diabetes\n* Established cardiovascular disease\n* Body Mass Index (BMI) \\\u003C27 kg\u002Fm²\n* Pregnancy\n* Inability to perform physical exercise\n\nSomatic risk findings at baseline:\n\n* HbA1c \\>57 mmol\u002Fmol (7.4%)\n* LDL cholesterol \\>5.0 mmol\u002FL\n* Blood pressure \\>180\u002F100 mmHg\n* Active malignant disease","25 Years","70 Years",{"count":381,"type":21},70,[102],"Norwegian patients with severe mental illnesses (SMI), such as schizophrenia spectrum or bipolar disorder, lose on average 10 years of life compared to mentally healthy individuals. Much of this gap is due to heart disease. Unhealthy lifestyle habits, including poor diet and physical inactivity, contribute to higher levels of metabolic risk factors for heart disease in this population.\n\nThe goal of this clinical trial is to find out if a lifestyle program including dietary counselling and regular physical exercise can help people with SMI to improve their physical and mental health.\n\nThe main questions it aims to answer are:\n\n* Does adherence to a healthy lifestyle program lead to reduced estimated risk of heart disease?\n* Does it change lifestyle habits, body weight and composition, and metabolic risk markers over six months?\n* Can participants with severe mental illness complete a healthy lifestyle program, and do they find it acceptable?\n\nResearchers will compare two groups: one that receives the lifestyle program in addition to regular mental health care, and one that receives regular care only.\n\nDuring the six month program, participants in the lifestyle group will:\n\n* Meet with a clinical dietitian once a month for dietary counselling\n* Take part in group-based physical activity sessions once a month, and receive support to follow a personal training plan\n\nAround 70 adults will take part in the study. The results may help improve the way lifestyle support is offered to people living with severe mental illness and inform health care providers about strategies to improve physical health in this vulnerable group.",[385,386,387,388,389,27,390,391],"Cardio Vascular Disease","Metabolic Syndrome (MetS)","Severe Mental Disorder","Schizophrenia and Schizophrenia Spectrum Psychosis","Bipolar Disease Type I","CVD Risk Factors","Severe Mental Illness",[391,393,394,395,396,397,398,399,400,401,402],"Cardiovascular Disease","Lifestyle Intervention","Healthy Diet","Exercise","CVD-risk","Schizophrenia","Antipsychotic Medication","Bipolar Disorder","Non-pharmacological intervention","Clinical Dietitian","2025-09-26",{"date":405,"type":42},"2025-10-02",{"date":407,"type":42},"2025-09-16",{"date":409,"type":21},"2028-06-30",{"name":411,"class":118},"Madeleine Elisabeth Angelsen",{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":379,"enrollmentInfo":420,"targetDuration":4,"studyType":22,"phases":422,"briefSummary":423,"conditions":424,"keywords":426,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":50},"100598719","phase-3-dortdf3tc-compared-with-bicftctaf-in-art-nave-people-living-with-hiv-and-overweight-or-obesity-100598719","NCT07075146","DOR\u002FTDF\u002F3TC COmpared With BIC\u002FFTC\u002FTAF in ART-Naïve People Living With HIV and Overweight or Obesity","Doravirine\u002FLamivudine\u002FTenofovir Disoproxil Fumarate COmpared With Bictegravir\u002FEmtricitabine\u002FTenofovir Alafenamide in ART-Naïve People Living With HIV and Overweight or Obesity","COATL","Inclusion Criteria:\n\n1. Adults (≥18 years) with confirmed HIV diagnosis, ART-naïve\n2. Signed informed consent\n3. HIV-1 RNA ≥1000 copies\u002FmL\n4. No history of PrEP or PEP failure\n5. BMI ≥25 kg\u002Fm² and body fat \\>20%\n6. Stable treatment for dyslipidemia (if applicable)\n7. No planned medication changes affecting weight\n8. Willingness to adhere to assigned ART\n9. Recent HIV-1 RNA and CD4+ results\n10. GFR (CKD-EPItip) ≥60 mL\u002Fmin\n11. ALT and AST \\\u003C90 IU\u002FL\n12. Willingness to report dietary or physical activity changes during follow-up Non-Inclusion Criteria\n\n1\\. Uncontrolled diabetes 2. Recent changes in insulin or hypoglycemic drugs (\\\u003C3 months) 3. Active malignancy 4. History of bariatric surgery 5. Allergies to study drugs 6. Hepatitis B and\u002For C coinfection 7. GFR \\\u003C60 mL\u002Fmin (CKD-EPI) 8. Drug interactions with ART regimens 9. Recent (60 days) use of anorectic drugs 10. Recent (30 days) hospitalization for severe illness 11. Unstable hypothyroidism\n\nExclusion Criteria:\n\n1. Loss of social security coverage\n2. Newly discovered allergy to study drugs\n3. Withdrawal of consent\n4. Hepatitis B or C infection acquired during follow-up\n5. Use of psychiatric or thyroid medications without a stable dose for ≥12 weeks\n6. Initiation or discontinuation of medications affecting weight after enrollment\n7. Unplanned bariatric surgery",{"count":421,"type":21},306,[61],"Background:Historically, HIV infection was associated with significant weight loss. However, weight gain is now commonly observed after initiating antiretroviral therapy (ART), particularly in individuals underweight at baseline. It remains unclear whether this weight gain reflects a \"return to health\" or results from drug-related or metabolic effects, and whether it persists beyond immune restoration. Recent evidence indicates that ART regimens containing second-generation integrase strand transfer inhibitors (INSTIs), such as bictegravir combined with tenofovir alafenamide, are associated with greater weight gain compared to other antiretroviral combinations, raising concerns about potential long-term metabolic consequences.Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine\u002FLamivudine\u002FTenofovir Disoproxil Fumarate (DOR\u002F3TC\u002FTDF) compared with Bictegravir\u002FEmtricitabine\u002FTenofovir Alafenamide (BIC\u002FFTC\u002FTAF) in ART-naïve people living with HIV (PWH) who are overweight or obese.Materials and Methods:This open-label, randomized clinical trial, approved by the Ethics and Scientific Research Committee (No. 3502), will be conducted at the Infectious Diseases Hospital of the National Medical Center \"La Raza\" from May 2025 to May 2027. ART-naïve PWH, recently diagnosed, with no prior use of pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), who do not require hospitalization, and have a body mass index (BMI) ≥25 kg\u002Fm² and body fat \\>20%, will be invited to participate. Participants will provide written informed consent and be randomized 1:1 to receive either DOR\u002F3TC\u002FTDF or BIC\u002FFTC\u002FTAF.",[425,64,27],"HIV - Human Immunodeficiency Virus",[427,265,106,428,429],"HIV","Doravirine","Bictegravir","2025-08-19",{"date":432,"type":42},"2025-08-24",{"date":434,"type":42},"2025-05-05",{"date":436,"type":21},"2028-08-01",{"name":438,"class":439},"José Antonio Mata Marín","OTHER_GOV"]