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

NCT07092618 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-07-30

No results posted yet for this study

Summary

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.

Conditions

  • Longevity
  • GLP-1
  • Geroscience
  • Aging

Interventions

DRUG

Metformin

Increasing doses from 500mg/d to 2000mg/d metformin

DRUG

Rapamycin

Increasing doses from 1mg/wk to 6mg/wk rapamycin

DRUG

Naltrexone

Increasing doses from 1.5mg b.i.d. to 4.5mg b.i.d. low-dose naltrexone

DIETARY_SUPPLEMENT

Vitamin C

Placebo control - increasing doses from 250mg/d to 1000mg/d vitamin C (ascorbic acid)

Sponsors & Collaborators

  • AgelessRx

    lead INDUSTRY

Principal Investigators

  • Stefanie Morgan, PhD · AgelessRx

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2025-08-31
Completion
2025-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07092618 on ClinicalTrials.gov