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)

What Was Tested

This clinical study looks at Semaglutide.

Semaglutide, a glucagon-like peptide 1 receptor agonist, is approved for the treatment of type 2 diabetes and obesity.

This study is approved by the Danish Medicines Agency and the regional scientific ethics committee of the Capital Region of Denmark (committee C, #H-20019008) and will be carried out in accordance with International Council for Harmonisation Good Clinical Practice guidelines and the Helsinki Declaration.

Who Took Part

The abstract describes 104 patients taking part.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

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

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

The comparison arm used a placebo, so changes seen with Semaglutide could be set against what happens without it.

This is a 26-week, double-blinded, randomised, placebo-controlled trial.

The primary endpoint is change from baseline in HbA1c.

Secondary endpoints include changes in body weight, hip and waist circumference and plasma levels of insulin, glucagon, glucose, and C-peptide, insulin sensitivity, beta cell function, hepatic function, fibrosis-4 score, lipid profile, incretin hormones, bone markers, body composition, bone density, proteomic analyses and oxidative stress markers.

Together with alcohol, tobacco and drug use, potential effects on the reward value of a sweet-fat stimulus, psychopathology, level of activity and quality of life will also be assessed.

What Was Measured

Topics PubMed links to this paper include Schizophrenia, Clozapine, Olanzapine, Glucagon-Like Peptide-1 Receptor, Prediabetic State, Diabetes Mellitus, Type 2 and Glycated Hemoglobin.

Author keywords: Adult psychiatry, DIABETES & ENDOCRINOLOGY, MENTAL HEALTH, PSYCHIATRY and Schizophrenia & psychotic disorders.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Semaglutide in 104 patients.

The publication is from 2023 (BMJ open), a journal based in England.

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