Actively Recruiting

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

Effectiveness of Alternative Therapies to Maintain Weight Loss After Stopping GLP-1 Medications A Randomized Controlled Trial

Led by AgelessRx · Updated on 2025-07-30

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

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

Who Can Participate

Age: 40Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Existing AgelessRx patient
  • Adults aged 40 to 85 years
  • Any sex
  • Any ethnicity
  • Body mass index (BMI) of 22 kg/m² or higher
  • Have used GLP-1 medications (Wegovy, Ozempic, or compounded forms) for at least three months before the study
  • Have lost at least 15 pounds while using GLP-1 medications
Not Eligible

You will not qualify if you...

  • Denied a longevity product by the AgelessRx medical team
  • History of bariatric surgery
  • Use of weight-loss medications other than GLP-1s within the past six months
  • Age under 40 years
  • Contraindications to naltrexone, metformin, or rapamycin
  • Significant psychiatric illness affecting participation
  • Pregnant or breastfeeding individuals

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 months

Participants receive increasing doses of assigned medications (metformin, metformin with low-dose naltrexone, metformin with rapamycin, or placebo vitamin C) while gradually stopping GLP-1 medications over 12 months.

Monthly visits during the first 3 months and monthly visits thereafter up to 12 months

Trial Site Locations

Total: 1 location

1

AgelessRx

Chicago, Illinois, United States, 60605

Actively Recruiting

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Research Team

S

Sajad Zalzala, MD

J

James Watson, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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