Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT07092618
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2024-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D009271', 'term': 'Naltrexone'}, {'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2024-12-18', 'studyFirstSubmitQcDate': '2025-07-28', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the effectiveness of metformin in maintaining GLP1-induced weight loss in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent)', 'timeFrame': '6 months', 'description': 'Participant weight will be self-reported every 4 weeks and will be compared against baseline weight as percent departure from baseline.\n\n1. Individuals that maintain the relative weight over the course of six months post-GLP-1 receptor agonist cessation\n2. Individuals that have less weight gain over the course of six months post-GLP-1 receptor agonist cessation using the combinatorial therapies than those who do not'}, {'measure': 'Evaluate the effectiveness of metformin + rapamycin in maintaining GLP1-induced weight loss in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Participant weight will be self-reported every 4 weeks and will be compared against baseline weight as percent departure from baseline.'}, {'measure': 'Evaluate the effectiveness of metformin + LDN in maintaining GLP1-induced weight loss in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Participant weight will be self-reported every 4 weeks and will be compared against baseline weight as percent departure from baseline.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the effectiveness of metformin on perceived metabolic health status in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent)', 'timeFrame': '6 months', 'description': 'Perceived metabolic health status will be assessed by the ISQ standardized questionnaire'}, {'measure': 'Evaluate the effectiveness of metformin on biological metabolic health in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent)', 'timeFrame': '6 months', 'description': 'Biological metabolic health will be assessed by a comprehensive metabolic blood panel, with each result reported in ng/dL and placed on a normalized scale identifying the upper and lower quartiles for healthy individuals'}, {'measure': 'Evaluate the effectiveness of metformin + rapamycin on perceived metabolic health status in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent)', 'timeFrame': '6 months', 'description': 'Perceived metabolic health status will be assessed by the ISQ standardized questionnaire'}, {'measure': 'Evaluate the effectiveness of metformin + rapamycin on biological metabolic health in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent)', 'timeFrame': '6 months', 'description': 'Biological metabolic health will be assessed by a comprehensive metabolic blood panel, with each result reported in ng/dL and placed on a normalized scale identifying the upper and lower quartiles for healthy individuals'}, {'measure': 'Evaluate the effectiveness of metformin + LDN on perceived metabolic health status in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent)', 'timeFrame': '6 months', 'description': 'Perceived metabolic health status will be assessed by the ISQ standardized questionnaire'}, {'measure': 'Evaluate the effectiveness of metformin + LDN on biological metabolic health in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent)', 'timeFrame': '6 months', 'description': 'Biological metabolic health will be assessed by a comprehensive metabolic blood panel, with each result reported in ng/dL and placed on a normalized scale identifying the upper and lower quartiles for healthy individuals'}, {'measure': 'Evaluate the effectiveness of metformin on mood-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Quality of life will be assessed by the PANAS standardized questionnaire'}, {'measure': 'Evaluate the effectiveness of metformin on physical health-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Quality of life will be assessed by the SF-36 standardized questionnaire'}, {'measure': 'Evaluate the effectiveness of metformin + rapamycin on mood-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Quality of life will be assessed by the PANAS standardized questionnaire'}, {'measure': 'Evaluate the effectiveness of metformin + rapamycin on physical health-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Quality of life will be assessed by the SF-36 standardized questionnaire'}, {'measure': 'Evaluate the effectiveness of metformin + LDN on mood-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Quality of life will be assessed by the PANAS standardized questionnaire'}, {'measure': 'Evaluate the effectiveness of metformin + LDN on physical health-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Quality of life will be assessed by the SF-36 standardized questionnaire'}, {'measure': 'Evaluate the effectiveness of metformin on tolerability of treatment in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Tolerability of treatment will be extrapolated from an extensive medical questionnaire sent to participants monthly and recorded throughout the trial'}, {'measure': 'Evaluate the effectiveness of metformin on long-term weight management practices in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Long-term weight management effectiveness will be assessed by reporting observed health changes as percent change in weight from baseline'}, {'measure': 'Evaluate the side effects of metformin in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Side effects will be monitored via an extensive medical questionnaire sent to participants monthly and recorded throughout the trial'}, {'measure': 'Evaluate the effectiveness of metformin + rapamycin on tolerability of treatment in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Tolerability of treatment will be extrapolated from an extensive medical questionnaire sent to participants monthly and recorded throughout the trial'}, {'measure': 'Evaluate the effectiveness of metformin + rapamycin on long-term weight management practices in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Long-term weight management effectiveness will be assessed by reporting observed health changes as percent change in weight from baseline'}, {'measure': 'Evaluate the side effects of metformin + rapamycin in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Side effects will be monitored via an extensive medical questionnaire sent to participants monthly and recorded throughout the trial'}, {'measure': 'Evaluate the effectiveness of metformin + LDN on tolerability of treatment in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Tolerability of treatment will be extrapolated from an extensive medical questionnaire sent to participants monthly and recorded throughout the trial'}, {'measure': 'Evaluate the effectiveness of metformin + LDN on long-term weight management practices in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Long-term weight management effectiveness will be assessed by reporting observed health changes as percent change in weight from baseline'}, {'measure': 'Evaluate the side effects of metformin + LDN in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)', 'timeFrame': '6 months', 'description': 'Side effects will be monitored via an extensive medical questionnaire sent to participants monthly and recorded throughout the trial'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Longevity', 'Aging', 'Healthy Aging', 'GLP-1'], 'conditions': ['Longevity', 'GLP-1', 'Geroscience', 'Aging']}, 'descriptionModule': {'briefSummary': '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/surveys 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Existing AgelessRx patient\n* Adults (40 - 85 years of age)\n* Any sex\n* Any ethnicity\n* BMI ≥ 22 kg/m\\^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 \\<40 years\n* Contraindications to naltrexone, metformin, or rapamycin\n* Significant psychiatric illness that may affect participation\n* Pregnant or breastfeeding individuals'}, 'identificationModule': {'nctId': 'NCT07092618', 'briefTitle': 'Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation', 'organization': {'class': 'INDUSTRY', 'fullName': 'AgelessRx'}, 'officialTitle': 'Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation: A Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'ALRx009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin + LDN', 'description': 'Month 1: 500mg/d MET, reduce Wegovy (or equivalent) to 1.7mg/wk or Ozempic (or equivalent) to 1.0mg/wk, add LDN 1.5mg b.i.d.\n\nMonth 2: Increase MET to 1000mg/d, reduce Wegovy (or equivalent) to 1.0mg/wk or Ozempic (or equivalent) to 0.5mg/wk, increase LDN to 3mg b.i.d.\n\nMonth 3: Increase MET to 1500mg/d, reduce Wegovy (or equivalent) to 0.5mg/wk or Ozempic (or equivalent) to 0.25mg/wk, increase LDN to 4.5mg b.i.d.\n\nMonths 4-12: increase MET to 2000mg/d, stop Wegovy (or equivalent) or Ozempic (or equivalent) entirely, continue LDN 4.5mg b.i.d.', 'interventionNames': ['Drug: Metformin', 'Drug: Naltrexone']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin', 'description': 'Month 1: 500mg/d MET, reduce Wegovy (or equivalent) to 1.7mg/wk or Ozempic (or equivalent) to 1.0mg/wk\n\nMonth 2: Increase MET to 1000mg/d, reduce Wegovy (or equivalent) to 1.0mg/wk or Ozempic (or equivalent) to 0.5mg/wk\n\nMonth 3: Increase MET to 1500mg/d, reduce Wegovy (or equivalent) to 0.5mg/wk or Ozempic (or equivalent) to 0.25mg/wk\n\nMonths 4-12: increase MET to 2000mg/d, stop Wegovy (or equivalent) or Ozempic (or equivalent) entirely', 'interventionNames': ['Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin + Rapamycin', 'description': 'Month 1: 500mg/d MET, reduce Wegovy (or equivalent) to 1.7mg/wk or Ozempic (or equivalent) to 1.0mg/wk, add 1mg/wk rapamycin\n\nMonth 2: Increase MET to 1000mg/d, reduce Wegovy (or equivalent) to 1.0mg/wk or Ozempic (or equivalent) to 0.5mg/wk, increase rapamycin to 2mg/wk\n\nMonth 3: Increase MET to 1500mg/d, reduce Wegovy (or equivalent) to 0.5mg/wk or Ozempic (or equivalent) to 0.25mg/wk, increase rapamycin to 4mg/wk\n\nMonths 4-12: increase MET to 2000mg/d, stop Wegovy (or equivalent) or Ozempic (or equivalent) entirely, increase rapamycin to 6mg/wk', 'interventionNames': ['Drug: Metformin', 'Drug: Rapamycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Vitamin C)', 'description': 'Month 1: 250mg/d Vitamin C, reduce Wegovy (or equivalent) to 1.7mg/wk or Ozempic (or equivalent) to 1.0mg/wk\n\nMonth 2: Increase Vitamin C to 500mg/d, reduce Wegovy (or equivalent) to 1.0mg/wk or Ozempic (or equivalent) to 0.5mg/wk\n\nMonth 3: Increase Vitamin C to 750mg/d, reduce Wegovy (or equivalent) to 0.5mg/wk or Ozempic (or equivalent) to 0.25mg/wk\n\nMonths 4-12: increase Vitamin C to 1000mg/d, stop Wegovy (or equivalent) or Ozempic (or equivalent) entirely', 'interventionNames': ['Dietary Supplement: Vitamin C']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'Increasing doses from 500mg/d to 2000mg/d metformin', 'armGroupLabels': ['Metformin', 'Metformin + LDN', 'Metformin + Rapamycin']}, {'name': 'Rapamycin', 'type': 'DRUG', 'description': 'Increasing doses from 1mg/wk to 6mg/wk rapamycin', 'armGroupLabels': ['Metformin + Rapamycin']}, {'name': 'Naltrexone', 'type': 'DRUG', 'description': 'Increasing doses from 1.5mg b.i.d. to 4.5mg b.i.d. low-dose naltrexone', 'armGroupLabels': ['Metformin + LDN']}, {'name': 'Vitamin C', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo control - increasing doses from 250mg/d to 1000mg/d vitamin C (ascorbic acid)', 'armGroupLabels': ['Placebo (Vitamin C)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60605', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Valdes, BS', 'role': 'CONTACT', 'email': 'avaldes@agelessrx.com', 'phone': '650-272-3169'}, {'name': 'Stefanie Morgan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AgelessRx', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Sajad Zalzala, MD', 'role': 'CONTACT', 'email': 'doctor@agelessrx.com', 'phone': '(313) 355-8657'}, {'name': 'James Watson, MD', 'role': 'CONTACT', 'email': 'jpfaber@ircm.org', 'phone': '(805) 497-8411'}], 'overallOfficials': [{'name': 'Stefanie Morgan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AgelessRx'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'accessCriteria': 'IPD will be shared with Institutional Review Board (IRB) approval or at the discretion of the PI/Sponsor'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AgelessRx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}