NCT07092618 Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation
| NCT ID | NCT07092618 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | AgelessRx |
| Condition | Longevity |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2024-12-17 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Existing AgelessRx patient * Adults (40 - 85 years of age) * Any sex * Any ethnicity * BMI ≥ 22 kg/m\^2 * Have been on GLP-1s (Wegovy, Ozempic, or a compounded form of GLP-1s) for at least three months before study initiation * Have lost at least 15 lbs during their GLP-1 use Exclusion Criteria: * 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 * Contraindications to naltrexone, metformin, or rapamycin * Significant psychiatric illness that may affect participation * Pregnant or breastfeeding individuals
Contact & Investigator
Stefanie Morgan, PhD
PRINCIPAL INVESTIGATOR
AgelessRx
Frequently Asked Questions
Who can join the NCT07092618 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Longevity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07092618 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07092618 currently recruiting?
Yes, NCT07092618 is actively recruiting participants. Contact the research team at doctor@agelessrx.com for enrollment information.
Where is the NCT07092618 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07092618 clinical trial?
NCT07092618 is sponsored by AgelessRx. The principal investigator is Stefanie Morgan, PhD at AgelessRx. The trial plans to enroll 150 participants.