Recruiting

GLP-1 Medications Weight Loss Maintenance with Alternative Therapies Study

Study Aim

This study aims to evaluate if taking metformin, metformin + rapamycin, or metformin + low-dose naltrexone (LDN) can help maintain weight loss in adults who have stopped using GLP-1 medications for weight loss.

What is being tested

Metformin

+ Naltrexone

+ Rapamycin

DrugDietary Supplement

Who is being recruted

From 40 to 85 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Placebo-ControlledPhase 2 & 3

Interventional

Study Start: December 2024

See protocol details

Summary

Principal SponsorAgelessRx

Study ContactSajad Zalzala, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 17, 2024

Actual date on which the first participant was enrolled.

This study aims to find out if certain alternative therapies can help people keep off weight they've lost after stopping GLP-1 medications. The therapies being tested are metformin alone or combined with either rapamycin or low-dose naltrexone. People who have been using GLP-1 medications for weight loss are the focus, especially as they begin to stop using these medications. The study hopes to see if these alternatives can prevent weight regain and improve overall metabolic health and quality of life, addressing a significant need for sustainable weight management solutions. Participants in the study will be divided into four groups to receive different treatments: no treatment (control), metformin, metformin with rapamycin, or metformin with low-dose naltrexone. They will follow a specific protocol for taking their assigned treatment and will undergo regular health evaluations. This includes filling out surveys about their health and quality of life, providing blood samples every 16 weeks, and sharing data from health tracking devices. These measures will help researchers understand how well each treatment works in maintaining weight loss and improving health markers like blood sugar and cholesterol levels.

Official TitleEffectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation: A Randomized, Controlled Trial

NCT07092618

Principal SponsorAgelessRx

Study ContactSajad Zalzala, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate

Existing AgelessRx patient

Adults (40 - 85 years of age)

Any sex

Any ethnicity

Show More Criteria

7 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Month 1: 500mg/d MET, reduce Wegovy (or equivalent) to 1.7mg/wk or Ozempic (or equivalent) to 1.0mg/wk Month 2: Increase MET to 1000mg/d, reduce Wegovy (or equivalent) to 1.0mg/wk or Ozempic (or equivalent) to 0.5mg/wk Month 3: Increase MET to 1500mg/d, reduce Wegovy (or equivalent) to 0.5mg/wk or Ozempic (or equivalent) to 0.25mg/wk Months 4-12: increase MET to 2000mg/d, stop Wegovy (or equivalent) or Ozempic (or equivalent) entirely

Group II

Experimental

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. Month 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. Month 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. Months 4-12: increase MET to 2000mg/d, stop Wegovy (or equivalent) or Ozempic (or equivalent) entirely, continue LDN 4.5mg b.i.d.

Group III

Experimental

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 Month 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 Month 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 Months 4-12: increase MET to 2000mg/d, stop Wegovy (or equivalent) or Ozempic (or equivalent) entirely, increase rapamycin to 6mg/wk

Group IV

Placebo

Month 1: 250mg/d Vitamin C, reduce Wegovy (or equivalent) to 1.7mg/wk or Ozempic (or equivalent) to 1.0mg/wk Month 2: Increase Vitamin C to 500mg/d, reduce Wegovy (or equivalent) to 1.0mg/wk or Ozempic (or equivalent) to 0.5mg/wk Month 3: Increase Vitamin C to 750mg/d, reduce Wegovy (or equivalent) to 0.5mg/wk or Ozempic (or equivalent) to 0.25mg/wk Months 4-12: increase Vitamin C to 1000mg/d, stop Wegovy (or equivalent) or Ozempic (or equivalent) entirely

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

AgelessRx

Chicago, United StatesOpen AgelessRx in Google Maps

Recruiting

One Study Center