Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Longevity, GLP-1, Geroscience, Aging

In brief

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. The main questions it aims to answer are: * 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. * 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. Researchers 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. Participants will: * Administer the assigned intervention following a dosing and administration protocol provided by the study and medical team. * Complete a medical intake for overall health status, medical history and demographic information, * Complete patient-reported outcomes/surveys and assessments * 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). * 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.

Key facts

Study ID

NCT07092618

Run by

AgelessRx

People needed

150

Starts

2024-12-17

Expected to finish

2025-08-01

Last updated by the study team

2025-07-30

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Existing AgelessRx patient
• Adults (40 - 85 years of age)
• Any sex
• Any ethnicity
• BMI ≥ 22 kg/m\^2
• Have been on GLP-1s (Wegovy, Ozempic, or a compounded form of GLP-1s) for at least three months before study initiation
• Have lost at least 15 lbs during their GLP-1 use

You may not qualify if…

• 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)
• History of bariatric surgery
• Use of weight-loss medications other than GLP-1s within the past 6 months
• Age <40 years
• Contraindications to naltrexone, metformin, or rapamycin
• Significant psychiatric illness that may affect participation
• Pregnant or breastfeeding individuals

Where it is running

• AgelessRx — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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