[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600063":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":53,"locations":63,"responsibleParty":83,"collaborators":35,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":35,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":35,"studyType":98,"phases":99,"briefSummary":102,"conditions":103,"keywords":108,"overallStatus":65,"whyStopped":35,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"AgelessRx","INDUSTRY",[8,15,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin + LDN","EXPERIMENTAL","Month 1: 500mg\u002Fd MET, reduce Wegovy (or equivalent) to 1.7mg\u002Fwk or Ozempic (or equivalent) to 1.0mg\u002Fwk, add LDN 1.5mg b.i.d.\n\nMonth 2: Increase MET to 1000mg\u002Fd, reduce Wegovy (or equivalent) to 1.0mg\u002Fwk or Ozempic (or equivalent) to 0.5mg\u002Fwk, increase LDN to 3mg b.i.d.\n\nMonth 3: Increase MET to 1500mg\u002Fd, reduce Wegovy (or equivalent) to 0.5mg\u002Fwk or Ozempic (or equivalent) to 0.25mg\u002Fwk, increase LDN to 4.5mg b.i.d.\n\nMonths 4-12: increase MET to 2000mg\u002Fd, stop Wegovy (or equivalent) or Ozempic (or equivalent) entirely, continue LDN 4.5mg b.i.d.",[13,14],"Drug: Metformin","Drug: Naltrexone",{"label":16,"type":10,"description":17,"interventionNames":18},"Metformin","Month 1: 500mg\u002Fd MET, reduce Wegovy (or equivalent) to 1.7mg\u002Fwk or Ozempic (or equivalent) to 1.0mg\u002Fwk\n\nMonth 2: Increase MET to 1000mg\u002Fd, reduce Wegovy (or equivalent) to 1.0mg\u002Fwk or Ozempic (or equivalent) to 0.5mg\u002Fwk\n\nMonth 3: Increase MET to 1500mg\u002Fd, reduce Wegovy (or equivalent) to 0.5mg\u002Fwk or Ozempic (or equivalent) to 0.25mg\u002Fwk\n\nMonths 4-12: increase MET to 2000mg\u002Fd, stop Wegovy (or equivalent) or Ozempic (or equivalent) entirely",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"Metformin + Rapamycin","Month 1: 500mg\u002Fd MET, reduce Wegovy (or equivalent) to 1.7mg\u002Fwk or Ozempic (or equivalent) to 1.0mg\u002Fwk, add 1mg\u002Fwk rapamycin\n\nMonth 2: Increase MET to 1000mg\u002Fd, reduce Wegovy (or equivalent) to 1.0mg\u002Fwk or Ozempic (or equivalent) to 0.5mg\u002Fwk, increase rapamycin to 2mg\u002Fwk\n\nMonth 3: Increase MET to 1500mg\u002Fd, reduce Wegovy (or equivalent) to 0.5mg\u002Fwk or Ozempic (or equivalent) to 0.25mg\u002Fwk, increase rapamycin to 4mg\u002Fwk\n\nMonths 4-12: increase MET to 2000mg\u002Fd, stop Wegovy (or equivalent) or Ozempic (or equivalent) entirely, increase rapamycin to 6mg\u002Fwk",[13,23],"Drug: Rapamycin",{"label":25,"type":26,"description":27,"interventionNames":28},"Placebo (Vitamin C)","PLACEBO_COMPARATOR","Month 1: 250mg\u002Fd Vitamin C, reduce Wegovy (or equivalent) to 1.7mg\u002Fwk or Ozempic (or equivalent) to 1.0mg\u002Fwk\n\nMonth 2: Increase Vitamin C to 500mg\u002Fd, reduce Wegovy (or equivalent) to 1.0mg\u002Fwk or Ozempic (or equivalent) to 0.5mg\u002Fwk\n\nMonth 3: Increase Vitamin C to 750mg\u002Fd, reduce Wegovy (or equivalent) to 0.5mg\u002Fwk or Ozempic (or equivalent) to 0.25mg\u002Fwk\n\nMonths 4-12: increase Vitamin C to 1000mg\u002Fd, stop Wegovy (or equivalent) or Ozempic (or equivalent) entirely",[29],"Dietary Supplement: Vitamin C",[31,36,40,44],{"type":32,"name":16,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Increasing doses from 500mg\u002Fd to 2000mg\u002Fd metformin",[16,9,20],null,{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Rapamycin","Increasing doses from 1mg\u002Fwk to 6mg\u002Fwk rapamycin",[20],{"type":32,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Naltrexone","Increasing doses from 1.5mg b.i.d. to 4.5mg b.i.d. low-dose naltrexone",[9],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":35},"DIETARY_SUPPLEMENT","Vitamin C","Placebo control - increasing doses from 250mg\u002Fd to 1000mg\u002Fd vitamin C (ascorbic acid)",[25],[50],{"name":51,"affiliation":5,"role":52},"Stefanie Morgan, PhD","PRINCIPAL_INVESTIGATOR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":35,"email":58},"Sajad Zalzala, MD","CONTACT","(313) 355-8657","doctor@agelessrx.com",{"name":60,"role":56,"phone":61,"phoneExt":35,"email":62},"James Watson, MD","(805) 497-8411","jpfaber@ircm.org",[64],{"facility":5,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"RECRUITING","Chicago","Illinois","60605","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-87.65005,41.85003,{"lat":75,"lon":74},[78,82],{"name":79,"role":56,"phone":80,"phoneExt":35,"email":81},"Ashley Valdes, BS","650-272-3169","avaldes@agelessrx.com",{"name":51,"role":52,"phone":35,"phoneExt":35,"email":35},{"type":84,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100600063","phase-2-effectiveness-of-alternative-therapies-in-maintaining-weight-loss-achieved-by-glp-1-medications-post-cessation-100600063",false,"NCT07092618","Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation","Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation: A Randomized, Controlled Trial","Inclusion Criteria:\n\n* Existing AgelessRx patient\n* Adults (40 - 85 years of age)\n* Any sex\n* Any ethnicity\n* BMI ≥ 22 kg\u002Fm\\^2\n* Have been on GLP-1s (Wegovy, Ozempic, or a compounded form of GLP-1s) for at least three months before study initiation\n* Have lost at least 15 lbs during their GLP-1 use\n\nExclusion Criteria:\n\n* Individuals who are denied a longevity product by the AgelessRx medical team will not be asked to participate in any product specific test(s) or questionnaire(s)\n* History of bariatric surgery\n* Use of weight-loss medications other than GLP-1s within the past 6 months\n* Age \\\u003C40 years\n* Contraindications to naltrexone, metformin, or rapamycin\n* Significant psychiatric illness that may affect participation\n* Pregnant or breastfeeding individuals","ALL","40 Years","85 Years",{"count":96,"type":97},150,"ESTIMATED","INTERVENTIONAL",[100,101],"PHASE2","PHASE3","The goal of this randomized, controlled trial is to evaluate the effectiveness of alternative therapies (metformin alone, with rapamycin, and with low-dose naltrexone) in maintaining weight loss in patients weaning off GLP-1 medications.\n\nThe main questions it aims to answer are:\n\n* Whether the combination of metformin, with or without rapamycin or low-dose naltrexone, will be adequate to maintain the relative weight of individuals gradually discontinuing GLP-1 receptor agonist use.\n* Whether individuals discontinuing GLP-1 receptor agonist use who instead use a combination of metformin, with or without rapamycin or low-dose naltrexone, will experience less weight regain over the course of six months post-cessation than those who do not use any alternative medications.\n\nResearchers will compare the four groups: 1) control, 2) metformin, 3) metformin + rapamycin, and 4) metformin + low-dose naltrexone, to assess changes in the percentage of weight regain, metabolic indicators (e.g., HbA1c, lipid profile), and quality of life PROs, six months after cessation of GLP-1 therapy.\n\nParticipants will:\n\n* Administer the assigned intervention following a dosing and administration protocol provided by the study and medical team.\n* Complete a medical intake for overall health status, medical history and demographic information,\n* Complete patient-reported outcomes\u002Fsurveys and assessments\n* Complete blood work at baseline and every 16 weeks thereafter to measure CBC, CMP, and standard health biomarker panels (e.g., cholesterol, glucose, creatinine, sodium, potassium).\n* Share data from health wearables with the research team throughout the study to improve the accuracy of evaluating activity, sleep, heart rate, and other related healthspan measures.",[104,105,106,107],"Longevity","GLP-1","Geroscience","Aging",[104,107,109,105],"Healthy Aging","2025-07-28",{"date":112,"type":113},"2025-07-30","ACTUAL",{"date":115,"type":113},"2024-12-17",{"date":117,"type":97},"2025-08",{"name":5,"class":6},1]