Trial results for the Phase 2 study (NCT05302596) investigating semaglutide in elderly obese patients were posted on ClinicalTrials.gov on 2025-04-17. The study aimed to investigate the effect of semaglutide addition to standard of care weight loss intervention on body weight and body composition.
Background
The study, titled "Semaglutide Use in Elderly Obese Patients," focused on the use of semaglutide in individuals experiencing obesity and aging. The trial aimed to evaluate the impact of adding semaglutide to a standard weight loss intervention, which included personalized lifestyle and exercise.
Trial design
The study (NCT05302596) was a Phase 2, single-center, prospective, controlled, randomized, and open-label trial. It enrolled 16 participants, investigating semaglutide in patients with obesity and aging. The intervention involved a semaglutide pen injector added to a personalized lifestyle and exercise program, compared against a standard of care only group. The study's objective was to assess the effect on body weight and body composition, as measured by DEXA.
Key results
The trial collected data on body composition, body weight, and total fat mass. For "Body Composition as Total Fat Mass/ Total Fat-free Mass Ratio" (Arbitrary units (ratio)):
- In the Semaglutide group, mean measurements were 1.04 (Standard Error: 0.07) and 0.96 (Standard Error: 0.06).
- In the Standard of Care Only group, mean measurements were 1.0 (Standard Error: 0.07) and 0.99 (Standard Error: 0.07).
For "Body Weight" (Kg):
- The Semaglutide group recorded mean weights of 107.8 Kg (Standard Error: 7.7) and 99.7 Kg (Standard Error: 7.2).
- The Standard of Care Only group recorded mean weights of 100.0 Kg (Standard Error: 6.7) and 97.1 Kg (Standard Error: 7.5).
For "Total Fat Mass" (Kg):
- The Semaglutide group had mean fat mass measurements of 52.1 Kg (Standard Error: 3.6) and 46.8 Kg (Standard Error: 3.6).
- The Standard of Care Only group had mean fat mass measurements of 47.8 Kg (Standard Error: 3.9) and 46.3 Kg (Standard Error: 4.1).
What this means
The posted results provide specific measurements for body composition, body weight, and total fat mass in elderly obese patients participating in this Phase 2 study. These data points contribute to the understanding of how semaglutide, when added to standard care, impacts these parameters. Further analysis or context would be needed to fully interpret the clinical significance of these measurements.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05302596, titled "Semaglutide Use in Elderly Obese Patients," were posted on 2025-04-17 on clinicaltrials.gov.