Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials

What Was Tested

The paper reports a study of Semaglutide, published as a randomized controlled trial.

Few studies have investigated the psychiatric safety of newly available antiobesity medications.

ClinicalTrials.gov Identifiers: STEP 1 (NCT03548935), 2 (NCT03552757), 3 (NCT03611582), and 5 (NCT03693430).

Who Took Part

The study group was 2 participants.

The age groups tagged for this paper are adults and middle-aged adults, both men and women.

This post hoc analysis of pooled data from the randomized, double-blind, placebo-controlled, multicenter phase 3a STEP 1, 2, and 3 trials (68 weeks; 2018-2020) and phase 3b STEP 5 trial (104 weeks; 2018-2021) included adults with overweight or obesity; STEP 2 participants also had type 2 diabetes.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and multicenter study.

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.

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

Some participants received a placebo instead of Semaglutide, giving a reference point.

More than one site took part, so the participants came from several places.

Trial designs have been published previously.

What Was Measured

The subject headings attached to it are Anti-Obesity Agents, Depression, Glucagon-Like Peptides, Obesity, Semaglutide, Suicidal Ideation and Weight Loss.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Semaglutide in 2 participants.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Its findings take up roughly 11 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2024 (JAMA internal medicine), a journal based in United States.

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