Semaglutide Use in Elderly Obese Patients

What Was Tested

This registered phase 2 trial tested Semaglutide.

It had two arms (groups): Semaglutide (experimental) and standard of care only (no intervention).

Standard of Care (SOC) weight loss intervention alone (personalized lifestyle and exercise).

The registry classes the interventions as drug.

More on the Plan

Priority of enrollment will be to match already existing and non-matched pair(s) before starting new ones.

However, participants will not need to wait until they are matched to be enrolled in the study.

The two open-label interventions are: 1.

Control group: Standard of care weight loss program that includes lifestyle changes and personalized exercise and dietary education. 2.

Who Took Part

The registry lists 16 actual participants took part.

It was open to people of any sex aged from 65 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 5 inclusion and 18 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-09-01 with completion listed for 2023-10-23.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Body Composition as Total Fat Mass/ Total Fat-free Mass Ratio (time frame: 16 weeks). Body Weight (time frame: 16 weeks).

It also tracked 2 secondary outcomes, for example Total Fat Mass and Total Fat-free Mass (Lean Mass).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 16 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.