Clinical trial

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

Opening soon · Phase 3 · 0 countries · Registry ID NCT07770282

Opening soonPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersAccepted

ConditionSchizophrenia Disorder, Metabolic Syndrome, Antipsychotic-induced Weight Gain, Cardiovascular Risk, Insulin Resistance

Full registry criteria

Inclusion Criteria: * 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. Exclusion Criteria: * ● On clozapine, aripiprazole, or a combination of SGAs. * Any contraindication to semaglutide. * Comorbid severe psychiatric, medical or neurological disorder. * History of organicity or significant head injury. * Pregnant or breastfeeding.

Treatments and study arms

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

Primary outcomes

Change in QRISK3 (QResearch Cardiovascular Risk Prediction Algorithm Version 3),10-year cardiovascular risk scoreBaseline to Week 24

QRISK3 is a cardiovascular risk prediction tool that calculates the 10-year absolute risk of developing cardiovascular disease (heart attack or stroke). The scale produces a percentage score ranging from 0% to 100%, where 0% represents minimum cardiovascular risk and 100% represents maximum theoretical risk. Risk stratification is typically classified as: \<5% = low risk, 5-10% = intermediate risk, 10-20% = high risk, and \>20% = very high risk. A score of \>20% (or approaching 100%) represents the worst clinical situation, indicating substantially elevated 10-year cardiovascular disease risk requiring intensive preventive interventions, including lifestyle modification and pharmacological treatment (statins, antihypertensives). QRISK3 incorporates clinical variables (age, blood pressure, cholesterol), demographic factors, and comorbidities to stratify risk and guide evidence-based prev…

Study locations

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No public site location was included in this record. Check the original registry for updates.