Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide for fat loss, obesity & body recomposition.

Participants will: * Self-administer study drug, semaglutide, once a week for 80 weeks * Complete metabolic and basic body measurements * Complete cognitive, mood, and dietary assessments * Complete questionnaires * Undergo MRIs.

It had two arms (groups): Overweight Group (BMI 27 - 40 kg/m2) (experimental) and Lean group (BMI 20 - 25 kg/m2) (no intervention).

Semaglutide.

The registry classes the interventions as drug.

More on the Plan

Based on the above, the researchers will assume a conservative minimum sample size of 43 per group to detect changes in brain health.

Therefore, the minimum sample size providing adequate statistical power for sex-stratified analyses will be 50 men and 50 women.

If enrollment falls below 100 total participants (50 per group) for feasibility reasons, the sample might be considered insufficient to support confirmatory sex-stratified analyses.

In this event, analyses will be conducted in the total sample only.

Who Took Part

240 planned participants were the target.

It was open to people of any sex aged from 35 years up to 55 years.

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

Examples of who could join: Individuals of age 35-55 years with BMI 27 - 40 kg/m2. Able to provide informed consent. Willing to self-inject semaglutide and follow study procedures for its entire duration. Individuals of age 35-55 years with BMI 20 - 25 kg/m2. Able to provide informed consent.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: current type 2 diabetes mellitus;; neurological disorders affecting the cns;; history or family history of medullary thyroid carcinoma or men2 syndrome.

How the Study Was Run

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

Groups ran in parallel: each of the fat loss, obesity & body recomposition 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 2026-08-01 with completion listed for 2028-12-01.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Serum C-reactive Protein (CRP) (time frame: Baseline & Change from Baseline). Serum Pro-inflammatory Cytokines (Interleukin-6, TNF-α, Interleukin-1β, and IL-1 Receptor Antagonist) (time frame: Baseline & Change from Baseline). Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) (time frame: Baseline & Change from Baseline).

It also tracked 15 secondary outcomes, for example Delay Discounting Task Score (Impulsive Choice), Penn Line Orientation Test Score (Visual Processing), Penn Progressive Matrices Score (Fluid Intelligence), Oral Reading Recognition Test Score (Language Ability), Penn Word Memory Test Score (Episodic Memory) and Relational Memory Task Score (Executive Function and Attention).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Semaglutide in 240 people with fat loss, obesity & body recomposition.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Fat loss, obesity & body recomposition research.