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Not 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)

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

0

Recruiting sites

-

Estimated enrollment

600

Study population

Cardiovascular Risk, Metabolic syndrome, Prediabetes / glucose intolerance, Psychiatric (schizophrenia / bipolar / depression)

Eligibility highlights

-

Primary endpoint

•QRISK3,10-year cardiovascular risk score

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07770282
Org study IDEMF/Psych/2026-27/35

Timeline

Milestones

Study first posted2026-08-18actual
Last update posted2026-08-18actual
Study start2026-12-01estimated
Primary completion2030-07-30estimated
Study completion2030-12-30estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Cardiovascular RiskMetabolic syndromePrediabetes / glucose intolerancePsychiatric (schizophrenia / bipolar / depression)

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
5
Cardiometabolic biomarkers
2
Weight & body composition
1
Glycemic / diabetes
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change Waist circumference

Time frame:Baseline, Week 12, Week 24

descriptive

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in insulin resistance (HOMA-IR)

Time frame:Baseline to Week 24

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Change in LDL/HDL ratio

Time frame:Baseline, Week 12, Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in high-sensitivity CRP (hs-CRP)

Time frame:Baseline to Week 24

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Treatment-emergent adverse events (TEAE)

Time frame:Continuous, weekly to Week 24

descriptive

Other (unclassified)

5 endpoints
Primary/protocol endpoint/low confidence

Change in QRISK3 (QResearch Cardiovascular Risk Prediction Algorithm Version 3),10-year cardiovascular risk score

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Leptin/Adiponectin ratio

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in PANSS score

Time frame:Baseline, Week 12, Week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in CGI-SCH score

Time frame:Baseline, Week 12, Week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in WHO QOL-BREF

Time frame:Baseline, Week 12, Week 24

change from baseline, improvement

Publications (6)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.