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

NCT07770282 · Not yet recruiting

Last updated 2026-09-22

This clinical trial tests whether the medication semaglutide, compared to a placebo, can improve heart disease risk factors in adults with schizophrenia who also have metabolic syndrome.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 600 people Planned (estimated).

Who can join Ages 18–60 · all sexes Healthy volunteers accepted.

Timeline Started 2026-12 · est. completion 2030-12

What this study is testing ClinicalTrials.gov NCT07770282 ↗

Description as written by the study sponsor.

Patients with schizophrenia on second-generation antipsychotics have a high burden of metabolic syndrome and elevated cardiovascular risk, with few effective treatment options. This multicentre, double-blind, placebo-controlled randomised trial evaluates whether adjunctive oral semaglutide 3 mg once daily, added to treatment as usual, reduces 10-year cardiovascular risk (QRISK3) and improves insulin resistance, lipids, weight and metabolic biomarkers over 24 weeks compared with placebo, while confirming psychiatric safety and tolerability.

Treatments tested

Semaglutide + TAU Drug

Semaglutide - oral tablet 3 mg once daily in the morning (titrated up from a low starting dose over 5 days), added to ongoing second-generation antipsychotic (TAU), for 24 weeks.
Placebo + TAU Drug

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

Main thing measured	Change in QRISK3 (QResearch Cardiovascular Risk Prediction Algorithm Version 3),10-year cardiovascular risk score
Sponsor	All India Institute of Medical Sciences, Bhubaneswar
Conditions studied	Schizophrenia Disorder, Metabolic Syndrome, Antipsychotic-induced Weight Gain, Cardiovascular Risk, Insulin Resistance
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07770282 ↗