Actively Recruiting
Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation
Led by AgelessRx · Updated on 2025-07-30
150
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Existing AgelessRx patient
- Adults 40 to 85 years of age
- 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 starting the study
- Have lost at least 15 pounds during GLP-1 use
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 6 months
- Younger than 40 years
- Contraindications to naltrexone, metformin, or rapamycin
- Significant psychiatric illness that may affect participation
- Pregnant or breastfeeding individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AgelessRx
Chicago, Illinois, United States, 60605
Actively Recruiting
Research Team
S
Sajad Zalzala, MD
CONTACT
J
James Watson, MD
CONTACT
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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