Study S001616

Efficacy and Safety of Semaglutide Versus Placebo on Cardiometabolic Profile in Patients With Schizophrenia With Metabolic Syndrome: A Multicentre, Double-Blind, Randomised Controlled Trial (ESCaMS Trial)

ClinicalTrials.gov record

Registration

Registration: NCT07770282
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: NOT_YET_RECRUITING
Enrollment: 600
Start: 2026-12-01
Primary completion: 2030-07-30
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Conditions: Schizophrenia Disorder; Metabolic Syndrome; Antipsychotic-induced Weight Gain; Cardiovascular Risk; Insulin Resistance
Interventions: DRUG:Semaglutide + TAU; DRUG:Placebo + TAU
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

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

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