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

StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07770282
Lead Sponsor All India Institute of Medical Sciences, Bhubaneswar
Collaborators: Indian Council of Medical Research
Conditions
(from sponsor)		 Schizophrenia Disorder, Metabolic Syndrome, Antipsychotic-induced Weight Gain, Cardiovascular Risk, Insulin Resistance
Related terms Insulin Resistance, Metabolic Syndrome, Schizophrenia
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov