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RecruitingPhase 2, PHASE3

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

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

Lead sponsor

AgelessRx

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

150

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI ≥22

Primary endpoint

Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07092618
Org study IDALRx009

Timeline

Milestones

Study start2024-12-17actual
Study first posted2025-07-30actual
Last update posted2025-07-30actual
Primary completion2025-08estimated (month precision)
Study completion2025-08estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age40 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (24)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL
9
Weight & body composition
6
Safety / tolerability / PK
6
Other (unclassified)
3

Weight & body composition

6 endpoints
Primary/protocol endpoint

Evaluate the effectiveness of metformin in maintaining GLP1-induced weight loss in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent)

Time frame:6 months

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Evaluate the effectiveness of metformin + rapamycin in maintaining GLP1-induced weight loss in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Evaluate the effectiveness of metformin + LDN in maintaining GLP1-induced weight loss in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Evaluate the effectiveness of metformin on long-term weight management practices in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Evaluate the effectiveness of metformin + rapamycin on long-term weight management practices in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Evaluate the effectiveness of metformin + LDN on long-term weight management practices in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

Body weight, % change

percent change from baseline, improvement

Patient-reported / QoL

9 endpoints
Secondary/protocol endpoint

Evaluate the effectiveness of metformin on perceived metabolic health status in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent)

Time frame:6 months

descriptive, improvement

Secondary/protocol endpoint

Evaluate the effectiveness of metformin + rapamycin on perceived metabolic health status in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent)

Time frame:6 months

descriptive, improvement

Secondary/protocol endpoint

Evaluate the effectiveness of metformin + LDN on perceived metabolic health status in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent)

Time frame:6 months

descriptive, improvement

Secondary/protocol endpoint

Evaluate the effectiveness of metformin on mood-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Evaluate the effectiveness of metformin on physical health-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Evaluate the effectiveness of metformin + rapamycin on mood-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Evaluate the effectiveness of metformin + rapamycin on physical health-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Evaluate the effectiveness of metformin + LDN on mood-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

descriptive, improvement

Secondary/protocol endpoint

Evaluate the effectiveness of metformin + LDN on physical health-related quality of life in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

SF-36 physical

change from baseline, improvement

Safety / tolerability / PK

6 endpoints
Secondary/protocol endpoint

Evaluate the effectiveness of metformin on tolerability of treatment in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

descriptive

Secondary/protocol endpoint

Evaluate the side effects of metformin in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

descriptive

Secondary/protocol endpoint

Evaluate the effectiveness of metformin + rapamycin on tolerability of treatment in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

descriptive

Secondary/protocol endpoint

Evaluate the side effects of metformin + rapamycin in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

Treatment-emergent AEs (any)

descriptive

Secondary/protocol endpoint

Evaluate the effectiveness of metformin + LDN on tolerability of treatment in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

descriptive

Secondary/protocol endpoint

Evaluate the side effects of metformin + LDN in participants weaning off of Ozempic (or equivalent) or Wegovy (or equivalent)

Time frame:6 months

Treatment-emergent AEs (any)

descriptive

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Evaluate the effectiveness of metformin on biological metabolic health in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent)

Time frame:6 months

descriptive

Secondary/protocol endpoint/low confidence

Evaluate the effectiveness of metformin + rapamycin on biological metabolic health in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent)

Time frame:6 months

descriptive

Secondary/protocol endpoint/low confidence

Evaluate the effectiveness of metformin + LDN on biological metabolic health in participants weaning off of Ozempic or Wegovy (or compounded semaglutide equivalent)

Time frame:6 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.