Efficacy and Safety of Semaglutide Versus Placebo on Cardiometabolic Profile in Patients With Schizophrenia With Metabolic Syndrome

What Was Tested

The trial (phase 3) is built around Semaglutide for insulin resistance, prediabetes & type 2 diabetes.

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

Drug: Placebo - matching oral tablet once daily in the morning, added to ongoing second-generation antipsychotic (TAU), for 24 weeks.

The registry classes the interventions as drug.

More on the Plan

Central computer-generated block randomisation stratified by centre is used, with allocation concealment by sequentially numbered opaque sealed envelopes (SNOSE).

Assessments occur at baseline, 12 weeks and 24 weeks, with weekly telephonic safety follow-up.

The primary endpoint is change in QRISK3 at 24 weeks.

Who Took Part

The registry lists 600 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Clinically diagnosed schizophrenia (ICD-11) on a second-generation antipsychotic (SGA) for more than 6 months. Metabolic syndrome per NCEP ATP III definition. Aged above 25 years, any gender. Patient / Legally Authorised Representative (LAR) provides voluntary written informed consent.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: ● on clozapine, aripiprazole, or a combination of sgas; any contraindication to semaglutide; pregnant or breastfeeding.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-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 insulin resistance, prediabetes & type 2 diabetes participants stayed in one arm throughout.

Blinding on both sides kept the insulin resistance, prediabetes & type 2 diabetes participants and researchers unaware of who received Semaglutide.

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

It started in 2026-12-01 with completion listed for 2030-07-30.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Change in LDL/HDL ratio, Change in insulin resistance (HOMA-IR), Change in high-sensitivity CRP (hs-CRP), Change Waist circumference, Change in Leptin/Adiponectin ratio and Change in PANSS score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 600 people with insulin resistance, prediabetes & type 2 diabetes.

With 600 participants it is a large trial for this field.

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, Insulin resistance, prediabetes & type 2 diabetes research.