Efficacy and Safety of Semaglutide Versus Placebo on Cardiometabolic Profile in Patients With Schizophrenia With Metabolic Syndrome
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: cardiovascular, psychiatric
- Who it enrolls
- age 18 Years to 60 Years; healthy volunteers accepted; no BMI minimum stated; conditions: Schizophrenia Disorder; Metabolic Syndrome; Antipsychotic-induced Weight Gain; Cardiovascular Risk
- Interventions
- Semaglutide + TAU; Placebo + TAU
- Conditions
- Schizophrenia Disorder; Metabolic Syndrome; Antipsychotic-induced Weight Gain; Cardiovascular Risk; Insulin Resistance
- Phase and size
- Phase 3 · 600 participants
- Dates
- Start 2026-12-01
Primary completion 2030-07-30 - Sponsor
- All India Institute of Medical Sciences, Bhubaneswar (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Change in QRISK3 (QResearch Cardiovascular Risk Prediction Algorithm Version 3),10-year cardiovascular risk scoreBaseline to Week 24
02Eligibility
Who can take part
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.
03Change log
Registry changes
No changes recorded since the trial was added.