[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599977":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":39,"locations":45,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GLP-1 RA","ACTIVE_COMPARATOR","Participants in this group will receive semaglutide therapy along with diet behavior counseling for 52 weeks",[13],"Drug: Semaglutide",{"label":15,"type":16,"description":17,"interventionNames":18},"GLP-1 RA + Exercise","EXPERIMENTAL","Participants in this group will receive semaglutide therapy along with diet behavior counseling and exercise training for 52 weeks.",[19,13],"Behavioral: Exercise training",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Exercise training","Participants will perform supervised exercise training sessions 3 days per week and unsupervised at-home sessions 2-3 days per week.",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Semaglutide","semaglutide 2.4 mg subcutaneous per week or max tolerated dose and diet behavior counseling",[9,15],[33,36],{"name":34,"affiliation":5,"role":35},"Joseph W Beals, PhD","STUDY_DIRECTOR",{"name":37,"affiliation":5,"role":38},"Samuel Klein, MD","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Coordinator","CONTACT","314-273-1879","NutritionResearch@wustl.edu",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","St Louis","Missouri","63110","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-90.19789,38.62727,{"lat":57,"lon":56},[60],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":26},{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100599977","glucagon-like-peptide-1-glp-1-receptor-agonist-therapy-and-exercise-training-in-people-with-obesity-100599977",false,"NCT07091500","Glucagon-like Peptide 1 (GLP-1) Receptor Agonist Therapy and Exercise Training in People With Obesity","Effect of GLP-1 Receptor Agonist Therapy With and Without Exercise Training on Muscle Mass and Physical Function in People With Obesity","Inclusion Criteria:\n\n* i) obesity (Body Mass Index ≥ 30 kg\u002Fm2)\n* ii) decreased physical function (Modified Physical Performance Test score 17 to 31)\n* iii) approval of their primary physician to participate in this study.\n\nExclusion Criteria:\n\n* i) unstable weight (\\>4% change during the last 2 months before entering the study)\n* ii) ≥150 min per week of structured exercise (e.g., jogging, activities that cause heavy breathing and sweating)\n* iii) diabetes\n* iv) significant cardiopulmonary disease (heart failure, angina, uncontrolled hypertension, chronic obstructive pulmonary disease) or other organ dysfunction (e.g., renal insufficiency \\[eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2\\])\n* v) therapy with a GLP-1 or other weight loss medications\n* vi) clinically significant gastric emptying abnormality or chronically take drugs that directly affect gastrointestinal motility\n* vii) history of chronic or acute pancreatitis\n* viii) thyroid-stimulating hormone (TSH) \\>1.5X the upper limit of normal (patients receiving treatment for hypothyroidism may be included provided their thyroid hormone replacement dose has been stable for at least 3 months)\n* ix) history of significantly active or unstable Major Depressive Disorder or other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 months that would interfere with study participation\n* x) acute or chronic hepatitis, or other liver disease other than Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD)\n* xi) family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2\n* xii) history of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years\n* xiii) tobacco use, excessive alcohol intake (≥3 drinks\u002Fday for men and ≥2 drinks\u002Fday for women) or active substance abuse with illegal drugs by self-report, or regular marijuana use within 3 months of enrollment and unwilling to abstain from marijuana during the trial\n* xiv) Use of medications that are known to affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued for this study\n* xv) have had bariatric surgery or plan to have endoscopic or bariatric surgery therapy for obesity\n* xvi) anemia (Hgb \\\u003C10 g\u002FdL)\n* xvii) Conditions that render subject unable to complete all testing procedures (e.g., severe ambulatory impairments, limb amputations, or metal implants that interfere with imaging procedures; coagulation disorders)\n* xii) history of seizure disorder\n* xix) Female who is pregnant, breast-feeding or intends to become pregnant\n* xx) allergy or hypersensitivity to GLP-1 RA medications\n* xxi) unable to grant voluntary informed consent\n* xxii) unable or unwilling to follow the study protocol or who, for any reason, the research team considers the participant is not an appropriate candidate for the study","ALL","50 Years","75 Years",{"count":74,"type":75},40,"ESTIMATED","INTERVENTIONAL",[78],"NA","The use of glucagon-like peptide receptor agonists (GLP-1 RAs) may have clinically important effects on skeletal muscle mass (SMM), and physical function. The effects of exercise training in conjunction with GLP-1 RA therapy on these outcomes has not been studied. Additionally, most people treated with GLP-1-based weight loss medications stop taking these medications within 1 year of initiating treatment. This is an important clinical concern because weight regain can occur after weight loss pharmacotherapy is stopped and the impact of stopping GLP-1 RA therapy on physical and metabolic function has not been studied.\n\nIn this study, the investigators will conduct a 2-year randomized clinical trial to evaluate body composition, muscle physical and metabolic function, and muscle strength in response to GLP-1 RA therapy, with or without exercise training, and subsequent treatment cessation on muscle-related outcomes.",[81,82],"Obesity","Skeletal Muscle","2025-09-22",{"date":85,"type":86},"2025-09-23","ACTUAL",{"date":88,"type":86},"2025-08-11",{"date":90,"type":75},"2029-08-01",{"name":5,"class":6},1]