Does GLP-1RA Prevent Deterioration of Metabolic State in Prediabetic and Diabetic Patients Treated With Antipsychotic Medication?

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide.

The antipsychotic-induced side-effects cause a major clinical problem among patients diagnosed with schizophrenia receiving antipsychotic treatment.

It had two arms (groups): Semaglutide injection once-weekly (active comparator) and Semaglutide-Placebo injection once-weekly (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

104 planned participants were the target.

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: Informed oral and written consent. Initiating current treatment with clozapine or olanzapine within 60 months (not PRN ordinations). Age 18 years to 65 years (both included). Body mass index (BMI) ≥25 kg/m2.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: acute worsening of psychosis based on a clinical evaluation (score of 6 or 7 on the cgi-s scale); coercive measures; females of child-bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant.

How the Study Was Run

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

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2021-09-01 with completion listed for 2026-03-01.

It ran at 3 sites in Denmark (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c) (time frame: 26 weeks).

It also tracked 24 secondary outcomes, for example Body weight (Kg), Hip and Waist circumference (Cm), Incretin hormones (Blood sampling), Bone Markers (Blood sampling), Lipid Profile (Blood sampling) and Hormones (blood sampling).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 104 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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