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Semaglutide in Comorbid Schizophrenia Spectrum Disorder and Obesity

Plain-language guide to NCT05333003: not phased randomized trial of Semaglutide, 92 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05333003
Phase
not phased
Status
active, not recruiting
Start
2022-05-25
Completion (planned or actual)
2026-08
Participants
92 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Schizophrenia Spectrum Disorders
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Semaglutide.

Rates of obesity in patients with schizophrenia-spectrum disorder (SSD)s have reached epidemic proportions, with established contributing effects of antipsychotic (AP) medications.

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

Semaglutide medication will be taken by participants on a weekly schedule, and adherence tracked.

Placebo will be taken by participants on a weekly schedule, and adherence tracked.

The registry classes the interventions as drug and other.

More on the Plan

People with SSDs die early of iatrogenic cardiometabolic disease.

Clinically, metformin remains the first line agent to mitigate this risk.

Hence, there is a need for interventions for AP-induced weight gain non-responsive to metformin.

This study will examine the effect of semaglutide on: 1.

Who Took Part

92 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Stable outpatients or inpatients aged 18-70 years, diagnosed with schizophrenia spectrum disorder, or major depressive disorder with psychotic features, or bipolar disorder (does not need to have psychotic features).

The full record lists 4 inclusion and 18 exclusion criteria; among the exclusions: patients with severe substance disorder other than tobacco or caffeine use disorder; only severe substance use disorder is exclusionary for cannabis use; liver, or renal dysfunction; A positive drug urine screen other than cannabis as per PI discretion.

How the Study Was Run

Design: randomized, parallel-group and single-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.

In this single-blind Semaglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2022-05-25 with completion listed for 2026-08.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Weight change (time frame: 32 weeks).

It also tracked 17 secondary outcomes, for example Body Mass Index (BMI), Waist circumference, Oral glucose tolerance test, Visceral and hepatic adiposity, Fasting lipid profile and Psychopathology - Brief Psychiatric Rating Scale (BPRS).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 92 people.

Its status is active not recruiting; 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.