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Semaglutide and Cognition in Healthy Volunteers

Plain-language guide to NCT06363487: not phased randomized trial of Semaglutide, 70 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06363487
Phase
not phased
Status
completed
Start
2024-06-06
Completion (planned or actual)
2024-12-11
Participants
70 (actual)
Design
randomized, triple-blind, basic_science
Conditions studied
Cognitive Change
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Semaglutide.

Semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1RA).

Primarily, it works by counteracting insulin-resistance and inducing weight loss.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

Semaglutide is a novel GLP-1RA licensed for T2DM and obesity, which mainly works by offsetting insulin-resistance and stimulating weight loss (1).

It also acts on various neurobiological, immunological, endocrine-metabolic, and gut-brain axis processes that play a role in depressive symptoms (2).

The proposed study investigates the effects of semaglutide on cognition and energy, which are currently unknown.

An experimental medicine trial that assesses the effects of semaglutide on reward sensitivity emotional cognition can validate its potential to be repurposed for treating depressive disorders (9).

Who Took Part

70 actual participants took part.

It was open to people of any sex aged from 21 years up to 55 years.

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

Examples of who could join: Male or female. Aged from 21 to 55 years. Sufficiently fluent English to understand and complete the tasks. Not currently taking any regular medications (except the contraceptive pill).

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: current alcohol or substance misuse disorder (\<6 months); current moderate or severe dyslexia; history of, or current pancreatitis.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2024-06-06 with completion listed for 2024-12-11.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Reward (learning) (time frame: 6-7 days). Reward (effort-based) (time frame: 6-7 days). Reward (primary) (time frame: 6-7 days).

It also tracked 5 secondary outcomes, for example Emotional processing, Emotional impulsivity, Memory (short- and medium-term) processing, Memory (working) processing and Energy/activity.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 70 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.