← Trials/Trial dossier/NCT05302596
Semaglutide Use in Elderly Obese Patients
Preserving Lean Body Mass During Weight Loss In Elderly Obese Patients With GLP-1 Receptor Agonist Treatment
Lead sponsor
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
16
actual
Study population
Obesity / overweight
Key I/E criteria
•BMI ≥30•Age ≥65
Primary endpoints
•Body Composition as Total Fat Mass/ Total Fat-free Mass Ratio•Body weight, absolute change (kg)
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Males and females age: ≥65 years
2. BMI ≥30 Kg/m2 AND waist circumference for women: > 80 cm and for men: > 90 cm
3. Stable body weight (no more than ±3 kg change during the 3 months prior to screening)
4. Able to participate in personalized physical activities and dietary instructions.
5. Participant must be able to read, write, and understand the English language and be able to provide written consent.
Exclusion criteria
1. Current diagnosis of weight changing condition including cancer, gastrointestinal conditions or eating disorders
2. GLP-1R agonists use within last 6 months
3. Diagnosis of type 1 or 2 diabetes
4. Impaired cognitive function (VA-St. Louis University Mental Survey (VA-SLUMS) score ≤ 19)
5. History of chronic/idiopathic acute pancreatitis
6. Personal/family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
7. Previous surgical treatment for obesity
8. Smoking or use of any nicotine products
9. Use of any medication that could interfere with trial results especially weight management drugs
10. Anticipated change in lifestyle (e.g., dietary, exercise or sleeping pattern) other than provided by the study.
11. Hepatic disease or cirrhosis
12. Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN) and/or Alanine aminotransferase (ALT) > 3X ULN
13. Inability to give informed consent
14. History of gastroparesis
15. History of serious hypersensitivity reaction to these agents
16. Alcoholism
17. Patients with retinopathy
18. Participation in any other concurrent interventional clinical trial -
Endpoints (8)
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.
Weight & body composition
8 endpointsBody Composition as Total Fat Mass/ Total Fat-free Mass Ratio
Time frame:16 weeks
ratio, improvement
Posted result
| Group | Value (mean), Arbitrary units (ratio) | 95% CI |
|---|---|---|
| SemaglutideBaseline | 1.04 | — |
| 16 Weeks | 0.96 | — |
| Standard of Care OnlyBaseline | 1.0 | — |
| 16 Weeks | 0.99 | — |
Body Weight
Time frame:16 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), Kg | 95% CI |
|---|---|---|
| SemaglutideBaseline | 107.8 | — |
| 16 weeks | 99.7 | — |
| Standard of Care OnlyBaseline | 100.0 | — |
| 16 weeks | 97.1 | — |
Body Composition as Total Fat Mass/ Total Fat-free Mass Ratio
Time frame:16 weeks
ratio, improvement
Body Weight
Time frame:16 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Total Fat Mass
Time frame:16 weeks
Total fat mass
change from baseline, improvement
Posted result
| Group | Value (mean), Kg | 95% CI |
|---|---|---|
| SemaglutideBaseline | 52.1 | — |
| 16 weeks | 46.8 | — |
| Standard of Care OnlyBaseline | 47.8 | — |
| 16 weeks | 46.3 | — |
Total Fat-free Mass (Lean Mass)
Time frame:16 weeks
Lean mass
change from baseline, improvement
Posted result
| Group | Value (mean), Kg | 95% CI |
|---|---|---|
| Semaglutidebaseline | 51.0 | — |
| 16 weeks | 49.5 | — |
| Standard of Care Onlybaseline | 47.8 | — |
| 16 weeks | 47.0 | — |
Total Fat Mass
Time frame:16 weeks
Total fat mass
change from baseline, improvement
Total Fat-free Mass (Lean Mass)
Time frame:16 weeks
Lean mass
change from baseline, improvement
Provenance
Sources
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.