Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue

NCT01794429 · Completed

Last updated 2026-05-28

This clinical trial tests whether a GLP-1 analogue can help people with schizophrenia who have gained weight due to antipsychotic medications.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 45 people

Who can join Ages 18–65 · all sexes

Timeline Started 2013-02 · est. completion 2015-06

Where 1 site · Denmark

What this study is testing ClinicalTrials.gov NCT01794429 ↗

Description as written by the study sponsor.

To examine if 3 months of treatment with a GLP-1 (glucagon-like-peptide-1) analogue can induce weight loss in obese, non-diabetic patients with a diagnosis within the schizophrenic spectrum. The investigators will also examine possible associations between GLP-1 treatment and peripheral metabolic parameters such as change in body fat and HbA1c. Moreover, the GLP-1 analogue treatment will be associated with the effects/changes on cognition and subjective quality of life. Possible cerebral effects (pro-cognitive) of the GLP-1 analogue treatment will associated and correlated with changes in the brain, functional magnetic resonance imaging (fMRI).

Treatments tested

Exenatide also known as Bydureon Drug

Subcutaneum injection of exenatide once-weekly for 3 months
Placebo Drug

Subcutaneum injection of placebo once-weekly for 3 months

Main thing measured	Weight loss
Sponsor	Bjorn H. Ebdrup
Conditions studied	Obesity, Metabolic Syndrome X, Drug-induced Obesity, Schizophrenia
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01794429 ↗