Phase 2
Completed N=16
Semaglutide Use in Elderly Obese Patients
Source: ClinicalTrials.gov NCT05302596 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Body Composition as Total Fat Mass/ Total Fat-free Mass Ratio — 1.04; 1.0; 0.96; 0.99 Arbitrary units (ratio)
Summary
This is a single-center, prospective, controlled, randomized and open label study to investigate the effect of the semaglutide addition to standard of care weight loss intervention (personalized lifestyle and exercise) in elderly obese subjects on body weight and body composition as assessed by DEXA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Composition as Total Fat Mass/ Total Fat-free Mass Ratio |
1.04; 1.0; 0.96; 0.99 | — |
| PRIMARY Body Weight |
107.8; 100.0; 99.7; 97.1 | — |
| SECONDARY Total Fat Mass |
52.1; 47.8; 46.8; 46.3 | — |
| SECONDARY Total Fat-free Mass (Lean Mass) |
51.0; 47.8; 49.5; 47.0 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females age: ≥65 years
- BMI ≥30 Kg/m2 AND waist circumference for women: > 80 cm and for men: > 90 cm
- Stable body weight (no more than ±3 kg change during the 3 months prior to screening)
- Able to participate in personalized physical activities and dietary instructions.
- Participant must be able to read, write, and understand the English language and be able to provide written consent.
Exclusion Criteria
- Current diagnosis of weight changing condition including cancer, gastrointestinal conditions or eating disorders
- GLP-1R agonists use within last 6 months
- Diagnosis of type 1 or 2 diabetes
- Impaired cognitive function (VA-St. Louis University Mental Survey (VA-SLUMS) score ≤ 19)
- History of chronic/idiopathic acute pancreatitis
- Personal/family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- Previous surgical treatment for obesity
- Smoking or use of any nicotine products
- Use of any medication that could interfere with trial results especially weight management drugs
- Anticipated change in lifestyle (e.g., dietary, exercise or sleeping pattern) other than provided by the study.
- Hepatic disease or cirrhosis
- Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN) and/or Alanine aminotransferase (ALT) > 3X ULN
- Inability to give informed consent
- History of gastroparesis
- History of serious hypersensitivity reaction to these agents
- Alcoholism
- Patients with retinopathy
- Participation in any other concurrent interventional clinical trial -
Data sourced from ClinicalTrials.gov (NCT05302596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.