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NCT05302596

Semaglutide Use in Elderly Obese Patients

Completed Phase 2 Results posted Last updated 17 April 2025
What this trial tests

Phase 2 trial testing Semaglutide Pen Injector in Obesity in 16 participants. Completed in 30 October 2024.

Timeline
1 September 2022
Primary endpoint
23 October 2023
30 October 2024

Quick facts

Lead sponsorState University of New York at Buffalo
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment16
Start date1 September 2022
Primary completion23 October 2023
Estimated completion30 October 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

State University of New York at Buffalo

Who can join

65 and older, any sex, with Obesity or Aging. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Body Composition as Total Fat Mass/ Total Fat-free Mass Ratio Primary · 16 weeks

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

Baseline
GroupValue95% CI
Semaglutide1.04± 0.07
Standard of Care Only1.0± 0.07
16 Weeks
GroupValue95% CI
Semaglutide0.96± 0.06
Standard of Care Only0.99± 0.07
Body Weight Primary · 16 weeks

body weight reported in Kg at at baseline and at 16 weeks in both groups

Baseline
GroupValue95% CI
Semaglutide107.8± 7.7
Standard of Care Only100.0± 6.7
16 weeks
GroupValue95% CI
Semaglutide99.7± 7.2
Standard of Care Only97.1± 7.5
Total Fat Mass Secondary · 16 weeks

total fat mass reported in Kg and measured using DEXA at baseline and at 16 weeks in both groups

Baseline
GroupValue95% CI
Semaglutide52.1± 3.6
Standard of Care Only47.8± 3.9
16 weeks
GroupValue95% CI
Semaglutide46.8± 3.6
Standard of Care Only46.3± 4.1
Total Fat-free Mass (Lean Mass) Secondary · 16 weeks

total fat-free mass (lean mass) reported in Kg and measured using DEXA at baseline and at 16 weeks in both groups

baseline
GroupValue95% CI
Semaglutide51.0± 4.2
Standard of Care Only47.8± 2.2
16 weeks
GroupValue95% CI
Semaglutide49.5± 4.0
Standard of Care Only47.0± 2.4

Adverse events — posted to ClinicalTrials.gov

Time frame: 16 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Semaglutide
Serious: 0/7 (0%)
Deaths: 0/7
Standard of Care Only
Serious: 0/7 (0%)
Deaths: 0/7
Other adverse events (3 terms — click to expand)

ReactionSystemSemaglutideStandard of Care Only
Gastrointestinal side effects: constipationGastrointestinal disorders
GI side effects: NauseaGastrointestinal disorders
GI side effects: VomitingGastrointestinal disorders

Data from ClinicalTrials.gov NCT05302596 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Semaglutide Pen Injector

Trials testing the same drug.

Other recruiting trials for Obesity

Currently open trials in the same condition.

Other State University of New York at Buffalo trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05302596.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing