NCT07770282Not yet recruitingPhase 3
Efficacy and Safety of Semaglutide Versus Placebo on Cardiometabolic Profile in Patients With Schizophrenia With Metabolic Syndrome
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)
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 10 Aug 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 30 Jul 2030
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Diseases
- Schizophrenia
- NCT number
- NCT07770282
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 600
- From 1 Dec 2026 to the primary completion date, 30 Jul 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- ● 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.