LEAN-PRO GLP-1

RecruitingPhase NA

Effect of GLP-1 Receptor Agonists on Body Composition in Obesity: The Role of Dietary Protein Consumption in Muscle Mass Maintenance

The Effect of GLP-1 Receptor Agonist-based Treatment on Body Composition and Muscle Mass in Adults With Obesity: The Role of Dietary Protein Consumption in Muscle Mass Maintenance

Lead sponsor

Hellenic Mediterranean University

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Enrollment

130

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Muscle Mass

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 IDNCT07495904

Org study ID159302

Secondary IDProtocol No. 44248University General Hospital of Heraklion (PAGNI)

Timeline

Milestones

Study first posted2026-03-27actual

Study start2026-03-30estimated

Last update posted2026-04-02actual

Primary completion2028-03-30estimated

Study completion2029-01-30estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age30 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Adults 30-65 years old

•BMI: ≥30 kg/m²

•Signed Informed Consent

Exclusion criteria

A. Metabolic and Medical Conditions:

•Uncontrolled type 2 diabetes (HbA1c > 9.0%)

•Known cardiovascular disease (e.g., coronary artery disease, heart failure NYHA 3-4)

•Chronic kidney disease stage 4-5 (GFR <60 ml/min)

•Liver disease (known hepatitis, ALT ≥ 3 or total bilirubin ≥ 2 times ULN)

•Inflammatory bowel disease

•Celiac disease

•History of pancreatitis

•Any disorder potentially causing malabsorption

•Active cancer or history of malignancy within the past 3 years

•Psychiatric disorders affecting adherence or assessment B. Medication and Supplement Use

•Chronic use of medications affecting metabolism or body composition (e.g., corticosteroids, anti-obesity drugs)

•Use of anti-inflammatory or antioxidant medications

•Use of probiotics, prebiotics, or laxatives within the last month

•Unstable medication regimen (changes within the past 3 months)

•Use of protein and creatine supplements.

C. Dietary and Lifestyle Factors:

•Alcohol or substance abuse

•Engagement in intense regular physical activity

D. Reproductive Status:

•Pregnancy or breastfeeding

•Pregnancy within the past 12 months

•Plans to become pregnant during the study

E. Other:

- Any condition that, in the opinion of the Investigator, may interfere with participation, adherence, or the interpretation of study results.

Endpoints (6)

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

Weight & body composition

Other clinical outcomes

Other (unclassified)

Weight & body composition

3 endpoints

Primary/protocol endpoint

Change from Baseline in Muscle Mass

Time frame:Baseline and End of Intervention (up to 24 weeks)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Composition Parameters

Time frame:Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention

change from baseline, improvement

Secondary/protocol endpoint

Long-term Weight Maintenance Efficiency

Time frame:From End of Intervention (up to 24 weeks) to 6 months post-intervention

percent change from baseline, improvement

componentsBody weight, absolute change (kg), Body weight, % change, Lean mass, Total fat mass

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Sarcopenia Risk

Time frame:Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention

categorical status, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Energy and Macronutrient Intake

Time frame:Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention

change from baseline, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change from Baseline in Biochemical and Urinary Markers

Time frame:Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention

change from baseline, improvement

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.