Semaglutide for Schizophrenia and Obesity
(Sema Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a medication to help overweight or obese patients with schizophrenia who are on antipsychotics and haven't lost enough weight with metformin. The medication works by making you feel full sooner and helping your body use insulin better. It has been shown to induce significant weight loss in individuals with obesity or overweight.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must not be on metformin for at least one week before joining. You also need to be on a stable dose of antipsychotic medication for at least three months.
Is semaglutide safe for humans?
Semaglutide has been studied for its safety in treating obesity and type 2 diabetes, and it is generally well-tolerated with some side effects. In studies, it has shown relatively well-tolerated side effects when used for weight management in people with severe mental illness and those taking antidepressants.12345
How is the drug semaglutide unique for treating schizophrenia and obesity?
Semaglutide is unique because it is a glucagon-like peptide-1 receptor agonist (a type of drug that mimics a hormone involved in blood sugar control) that is administered once a week and has shown promise in managing weight gain associated with antipsychotic medications, which is a common issue in schizophrenia treatment. Unlike other treatments, it offers significant weight loss and cardiovascular benefits, making it a novel option for patients with both schizophrenia and obesity.12467
What data supports the effectiveness of the drug semaglutide for schizophrenia and obesity?
Research shows that semaglutide, a drug approved for type 2 diabetes and obesity, may help reduce weight gain associated with antipsychotic medications in patients with severe mental illness. In a study, patients who did not respond to metformin experienced significant weight loss after using semaglutide, suggesting its potential effectiveness in managing weight in similar conditions.12489
Who Is on the Research Team?
Margaret Hahn, MD, PhD
Principal Investigator
Centre for Addiction and Mental Health
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with schizophrenia spectrum disorder or related conditions, who are obese due to antipsychotic medications and haven't lost weight on metformin. Participants must have a BMI of at least 30, or 27 with certain health issues, and can't be pregnant, nursing, or without contraception if applicable.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive semaglutide or placebo on a weekly schedule, with adherence tracked
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Semaglutide
Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Obesity
- Type 2 diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre for Addiction and Mental Health
Lead Sponsor