Semaglutide in Comorbid Schizophrenia Spectrum Disorder and Obesity

Sponsor
Centre for Addiction and Mental Health
Study ID
NCT05333003
Status
Active Not Recruiting

Conditions

  • Schizophrenia Spectrum Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    The semaglutide dose will start with 0.25 mg/week, and slowly increased every four weeks as tolerated up to a maximal dose of 2 mg/week
  • Placebo — OTHER
    Placebo will be provided to participants

Study Details

Rates of obesity in patients with schizophrenia-spectrum disorder (SSD)s have reached epidemic proportions, with established contributing effects of antipsychotic (AP) medications. Among agents approved for chronic weight management, glucagon-like peptide-1 receptor agonists (GLP-1RA) are associated with reductions in cardiovascular mortality, with recent FDA approval for once weekly semaglutide for this indication. This study will investigate whether semaglutide is effective in reducing body weight in overweight or obese individuals with SSDs who are on APs and do not demonstrate adequate weight loss on metformin (the first line treatment for weight loss in SSDs).

Key Dates

Start date
May 25, 2022
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
    Semaglutide medication will be taken by participants on a weekly schedule, and adherence tracked
  • Placebo Comparator: Placebo
    Placebo will be taken by participants on a weekly schedule, and adherence tracked

Primary Outcome Measure

Weight change [ Time Frame: 32 weeks ]

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