Primary outcomeMean· 16 weeks
Body Composition as Total Fat Mass/ Total Fat-free Mass Ratio
| Group | Value (Arbitrary units (ratio)) | Spread |
|---|---|---|
| Semaglutide | 1.04 | 0.07 |
| Standard of Care Only | 1.0 | 0.07 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataSemaglutide Use in Elderly Obese Patients
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 16 participants (actual)
- Sponsor
- State University of New York at Buffalo · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 1 Sept 2022
- Primary completion
- 23 Oct 2023
- Completion
- 30 Oct 2024
- First posted
- 31 Mar 2022
- Last update posted
- 17 Apr 2025
- Conditions
- Obesity · Aging
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2022202320242025
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Semaglutide Pen InjectorDrug
Arms2
Experimental
Semaglutide
Semaglutide, added to standard of care, starting dose of 0.25mg titrated up to 1mg dose. for a total of 16 weeks.
No intervention
standard of care only
Standard of Care (SOC) weight loss intervention alone (personalized lifestyle and exercise)
Primary outcomes2
Outcomes the sponsor listed as primary.
Body Composition as Total Fat Mass/ Total Fat-free Mass Ratio
Time frame · 16 weeks
Registry description
total fat mass/total fat-free mass ratio reported as arbitrary units (ratio), calculated by dividing total fat mass by total fat-free mass (lean mass) at baseline and at 16 weeks in both groups. Primary measurements of fat and fat-free mass is done using DEXA
Body Weight
Time frame · 16 weeks
Registry description
body weight reported in Kg at at baseline and at 16 weeks in both groups
Secondary outcomes(2)
Total Fat Mass
Time frame · 16 weeks
Registry description
total fat mass reported in Kg and measured using DEXA at baseline and at 16 weeks in both groups
Total Fat-free Mass (Lean Mass)
Time frame · 16 weeks
Registry description
total fat-free mass (lean mass) reported in Kg and measured using DEXA at baseline and at 16 weeks in both groups
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· 16 weeks
Body Weight
| Group | Value (Kg) | Spread |
|---|---|---|
| Semaglutide | 107.8 | 7.7 |
| Standard of Care Only | 100.0 | 6.7 |
Secondary and other outcome results(2)
Secondary outcomeMean· 16 weeks
Total Fat Mass
| Group | Value (Kg) | Spread |
|---|---|---|
| Semaglutide | 52.1 | 3.6 |
| Standard of Care Only | 47.8 | 3.9 |
Secondary outcomeMean· 16 weeks
Total Fat-free Mass (Lean Mass)
| Group | Value (Kg) | Spread |
|---|---|---|
| Semaglutide | 51.0 | 4.2 |
| Standard of Care Only | 47.8 | 2.2 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| SemaglutideSemaglutide, added to standard of care, starting dose of 0.25mg titrated up to 1mg dose. for a total of 16 weeks. Semaglutide Pen Injector: semaglutide (up to 1mg) once weekly injection added to the standard of care weight loss program. Semaglutide dose will be started at 0.25 mg dose during the baseline visit and doubled every 2 weeks up to 1mg dose or up to maximum tolerable dose for total of 16 weeks of intervention | 0 / 7 | 0 / 7 | 5 / 7 |
| Standard of Care OnlyStandard of Care (SOC) weight loss intervention alone (personalized lifestyle and exercise) | 0 / 7 | 0 / 7 | 1 / 7 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 65 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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 -
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