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.
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.
● 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.
All India Institute of Medical Sciences, Bhubaneswar
Lead sponsor
Indian Council of Medical Research
Collaborator