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

Sponsor
All India Institute of Medical Sciences, Bhubaneswar
Study ID
NCT07770282
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Antipsychotic-induced Weight Gain
  • Cardiovascular Risk
  • Insulin Resistance
  • Metabolic Syndrome
  • Schizophrenia Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Dec 1, 2026
Status verified
Aug 2026
Primary completion
Jul 30, 2030
Completion
Dec 30, 2030

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Change in QRISK3 (QResearch Cardiovascular Risk Prediction Algorithm Version 3),10-year cardiovascular risk score [ Time Frame: Baseline to Week 24 ]

Central Contacts

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