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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?

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518746-24-00
Enrollment
104
Registered
2024-11-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief summary

The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c)

Detailed description

Changes in body weight, hip, waist circumference, blood pressure, heart rate, plasma insulin, C-peptide, glucagon, incretin hormones, lipid profile, proteomics and bone markers, insulin sensitivity, beta-cell function (evaluated by HOMA. Body composition and bone density evaluated by DXA-scan), liver function (transaminases), liver fibrosis (fibrosis-4 (FIB-4) score), alcohol, tobacco and drug use, preference for sweet and fatty candy, psychopathology, activity and quality of life.

Interventions

DRUGPlacebo for semaglutide
DRUGCompCart 1.5 ml
DRUGPDS290

Sponsors

Psykiatrisk Center Kobenhavn
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c)

Secondary

MeasureTime frame
Changes in body weight, hip, waist circumference, blood pressure, heart rate, plasma insulin, C-peptide, glucagon, incretin hormones, lipid profile, proteomics and bone markers, insulin sensitivity, beta-cell function (evaluated by HOMA. Body composition and bone density evaluated by DXA-scan), liver function (transaminases), liver fibrosis (fibrosis-4 (FIB-4) score), alcohol, tobacco and drug use, preference for sweet and fatty candy, psychopathology, activity and quality of life.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026