Study S001916

Does the Glucagon-like Peptide-1 Receptor Agonist Semaglutide Prevent Deterioration of Metabolic State in Prediabetic or Diabetic Patients With Schizophrenia Treated With the Antipsychotic Compounds Clozapine or Olanzapine?

ClinicalTrials.gov record Statistical Analysis Plan (PDF)

Registration

Registration: NCT04892199
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: TRIPLE
Status: UNKNOWN
Enrollment: 104
Start: 2021-09-01
Primary completion: 2026-03-01
Lead sponsor: Anders Fink-Jensen, MD, DMSci
Conditions: Metabolic Disturbance; Schizophrenia; Type 2 Diabetes; Clozapine; GLP-1; Olanzapine
Interventions: DRUG:Semaglutide, 1.34 mg/mL; DRUG:Semaglutide-placebo
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c). [26 weeks]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0004173	Semaglutide and Early-Stage Metabolic Abnormalities in Individuals With Schizophrenia Spectrum Disorders: A Randomized Clinical Trial. Sass MR, JAMA psychiatry	2026	Randomized trial	PMID 41335431 DOI	cites ClinicalTrials.gov:NCT04892199; registry reference DERIVED:41335431
R0008715	Effect of the GLP-1 receptor agonist semaglutide on metabolic disturbances in clozapine-treated or olanzapine-treated patients with a schizophrenia spectrum disorder: study protocol of a placebo-controlled, randomised clinical trial (SemaPsychiatry). Sass MR, BMJ open	2023	Protocol	PMID 36720576 DOI	cites ClinicalTrials.gov:NCT04892199; registry reference DERIVED:36720576