RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-17
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07092618

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Existing AgelessRx patient
  2. * Adults (40 - 85 years of age)
  3. * Any sex
  4. * Any ethnicity
  5. * BMI ≥ 22 kg/m\^2
  6. * Have been on GLP-1s (Wegovy, Ozempic, or a compounded form of GLP-1s) for at least three months before study initiation
  7. * Have lost at least 15 lbs during their GLP-1 use
  1. * 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)
  2. * History of bariatric surgery
  3. * Use of weight-loss medications other than GLP-1s within the past 6 months
  4. * Age \<40 years
  5. * Contraindications to naltrexone, metformin, or rapamycin
  6. * Significant psychiatric illness that may affect participation
  7. * Pregnant or breastfeeding individuals

Contacts and Locations

Study Contact

Sajad Zalzala, MD
CONTACT
(313) 355-8657
doctor@agelessrx.com
James Watson, MD
CONTACT
(805) 497-8411
jpfaber@ircm.org

Principal Investigator

Stefanie Morgan, PhD
PRINCIPAL_INVESTIGATOR
AgelessRx

Study Locations (Sites)

AgelessRx
Chicago, Illinois, 60605
United States

Collaborators and Investigators

Sponsor: AgelessRx

  • Stefanie Morgan, PhD, PRINCIPAL_INVESTIGATOR, AgelessRx

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-17
Study Completion Date2025-08

Study Record Updates

Study Start Date2024-12-17
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • Longevity
  • Aging
  • Healthy Aging
  • GLP-1

Additional Relevant MeSH Terms

  • Longevity
  • GLP-1
  • Geroscience
  • Aging