Home-based Intervention With Semaglutide Treatment Of Neuroleptica-Related Prediabetes

What Was Tested

The trial (phase 2) is built around Semaglutide.

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

The registry classes the interventions as drug and other.

More on the Plan

Quality control: Usual quality control procedures will be followed in accordance with the ICH Guideline for Good Clinical Practice (GCP).

The GCP unit at OUH will be responsible for monitoring the study in accordance with GCP guidelines.

Randomization: A total of 154 participants will be randomized: 77 participants will be randomized to the Semaglutide group and 77 participants will be randomized to the placebo group (randomization ratio 1:1).

The participant is assigned a subject number when consent is obtained, inclusion and exclusion criteria have been reviewed and the participant otherwise meets the requirements for study participation and continues to participate in the study.

Who Took Part

154 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Diagnosed with schizophrenia spectrum disorder (ICD10 codes DF20, DF21 or DF25). Age between 18 and 60 years (both included). Approved contraception for female participants. Antipsychotic SGA treatment for at least 6 months. Stable co-medication for at least 1 month.

The full record lists 9 inclusion and 10 exclusion criteria; among the exclusions: active malignant disease within the last 5 years; pregnancy or breast feeding; unwillingness to allow home visits by a study nurse.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

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

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

It started in 2022-01-01 with completion listed for 2024-03-18.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (mmol/mol) (time frame: 30 weeks).

It also tracked 16 secondary outcomes, for example Weight, Height, Chaneges in body mass index (BMI), Waist circumference (cm), Glycemic status (blood sampling) and Plasma triglyceride.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 154 people.

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

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