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

Sponsor
Jan Frystyk
Study ID
NCT05193578
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

To investigate whether the Glucagon Like Peptide 1 (GLP-1) Semaglutide (1.34 mg/ml) has preventive effect compared to placebo in the development of diabetes and Metabolic Syndrome in people with pre-diabetes, overweight and schizophrenia, who receive antipsychotic treatment. Furthermore to investigate for an effect of Semaglutide compared to placebo on psychotic symptoms and quality of life in people with schizophrenia, prediabetes and overweight.

Key Dates

Start date
Jan 1, 2022
Status verified
Jul 2024
Primary completion
Mar 18, 2024
Completion
May 1, 2024

Study Design

Enrollment
154 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Semaglutide
    Active Comparator: Semaglutide injection once-weekly The participants start with Semaglutide given as 0.25 mg subcutaneously per week for 4 weeks. Then, the dose is uptitrated to 0.5 mg subcutaneously per week for 4 weeks, whereafter the highest dose is reached: 1 mg subcutaneously per week until the end of the study (week 30). Subjects, who experience side effects that hinder a stepwise increase in study drug, will remain at the highest possible tolerated dose for the rest of the study.
  • Placebo Comparator: Placebo
    Semaglutide-Placebo injections once weekly. The Semaglutide-Placebo pens are produced by Novo Nordisk A/S and resemble the pens containing active drug. Semaglutide-Placebo pens contain vehicle, i.e. no active drug. Semaglutide-Placebo is administered similarly to semaglutide. That is using the same uptitration regime and volume as the active comparator, Semaglutide. Subjects, who experience side effects that hinder a stepwise increase in Semaglutide-Placebo, will remain at the highest possible tolerated dose for the rest of the study.

Primary Outcome Measure

HbA1c (mmol/mol) [ Time Frame: 30 weeks ]

Related Studies