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Phase 2
Phase 3
Age: 40Years - 85Years
All Genders
ID07092618

Randomized Trial of Metformin and Other Therapies to Maintain Weight Loss After Stopping GLP-1 Medications in Adults Aged 40 to 85

Led by AgelessRx · Updated on 2025-07-30

150

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to assess the effectiveness of alternative therapies in maintaining weight loss for individuals tapering off GLP-1 medications such as Wegovy or Ozempic. The study compares metformin alone, metformin combined with rapamycin, and metformin combined with low-dose naltrexone against a placebo group. Researchers want to find out if these combinations help prevent weight regain and improve metabolic health and quality of life during the six months following GLP-1 cessation. Participants will be randomly assigned to one of four groups placebo vitamin C, metformin, metformin plus rapamycin, or metformin plus low-dose naltrexone. Each group follows a specific dosing schedule over 12 months, starting with reduced doses of GLP-1 drugs and gradually increasing the study medications. After three months, GLP-1 medications are stopped entirely while study treatments continue to be adjusted according to protocol. During the study, participants will provide medical histories, complete surveys about their health and quality of life, and undergo blood tests every 16 weeks to monitor biomarkers such as cholesterol and glucose. They will also share data from wearable health devices to track activity, sleep, and heart rate. The main outcomes measured include weight maintenance, metabolic health markers, quality of life, treatment tolerability, and side effects over six months after stopping GLP-1 therapy.

CONDITIONS

Brief Title

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

Research Team

S

Sajad Zalzala, MD

J

James Watson, MD

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