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

What Was Tested

The trial (phase 3) is built around Exenatide.

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.

It had two arms (groups): Placebo (placebo comparator) and exenatide (active comparator).

Subcutaneum injection of placebo once-weekly for 3 months.

Subcutaneum injection of exenatide once-weekly for 3 months.

The registry classes the interventions as drug.

More on the Plan

The primary endpoint is weight loss after 3 months of treatment with the GLP-1 analogue exenatide (Bydureon®).

Secondary endpoints comprise both physiological/metabolic parameters and cognitive measurements: * Metabolic endpoints include amongst others: changes in body fat (DEXA-scan) and changes of the HbA1c(average blood glucose levels), cholesterol and triglycerides.

Moreover physiological effects will be examined eg possible effect on central/peripheral bloodpressure and heart rate. * Cerebral endpoints will be investigated via functional magnetic resonance imaging (fMRI); including potential neuroprotective effects of exenatide.

The main focus is potential hippocampal volume changes and potential changes in cerebral blood flow.

Who Took Part

Enrollment: 45 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age: 18 - 65 years. Diagnosis of the schizophrenia spectrum (ICD-10: F20.x, F25.x)both in-patients and out-patients will be included. Current and unchanged treatment with at least one antipsychotic drug (FGA and/or SGA and/or depot treatment). BMI ≥30 kg/m2.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: substance dependence (icd-10: f1x.2 (apart from nicotine addiction f17.2)); contraindications to mri (metal implants, pacemakers, severe claustrophobia, ≥150 kg (max. bed weight in the mri scanner)); previous head trauma with a loss of consciousness for more than 5 minutes.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Exenatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant and investigator.

It started in 2013-02 with completion listed for 2015-06.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Weight loss (time frame: 3 months).

It also tracked 1 secondary outcome, for example Effects of GLP-1-analogue treatment on body fat composition.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 45 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.