92 Participants Needed

Semaglutide for Schizophrenia and Obesity

(Sema Trial)

MH
MA
Overseen ByMahavir Agarwal, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Centre for Addiction and Mental Health
Must be taking: Antipsychotics
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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?

MH

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

My BMI is over 30, or over 27 with a weight-related health issue, or over 25 and I've gained more than 5% of my weight due to AP treatment.
I have been on a stable dose of antipsychotic medication for over 3 months.
I couldn't lose 5% of my weight on metformin over 16 weeks and haven't taken it for at least a week.

Exclusion Criteria

I have diabetes, with an HbA1c level over 6.5%.
You have a serious addiction to drugs or alcohol, except for tobacco or caffeine. Only severe addiction to cannabis would exclude you from participating.
Any condition that interferes with the safe acquisition of MRI data such as metal implants, pacemakers, aneurysm clips, cochlear implants (only for the MRI component; can participate in the remainder of the trial)
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide or placebo on a weekly schedule, with adherence tracked

32 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo
  • Semaglutide
Trial Overview The study tests whether semaglutide helps overweight individuals with schizophrenia spectrum disorders lose weight compared to a placebo. These patients struggle with obesity partly because of their antipsychotic medication and haven't had success losing weight on metformin.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
Semaglutide medication will be taken by participants on a weekly schedule, and adherence tracked
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be taken by participants on a weekly schedule, and adherence tracked

Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
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Approved in United States as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
๐Ÿ‡ฏ๐Ÿ‡ต
Approved in Japan as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Wegovy for:
  • Obesity
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Rybelsus for:
  • Type 2 diabetes

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials
388
Recruited
84,200+

Published Research Related to This Trial

In a study of 12 patients with severe mental illness who did not respond to metformin for antipsychotic-associated weight gain, semaglutide treatment resulted in significant weight loss over 12 months, averaging 8.67 kg (p=0.04).
Semaglutide was well-tolerated with manageable side effects, suggesting it could be a promising alternative for patients struggling with weight gain from antipsychotic medications, although further randomized control trials are needed to confirm these results.
Semaglutide for the treatment of antipsychotic-associated weight gain in patients not responding to metformin - a case series.Prasad, F., De, R., Korann, V., et al.[2023]
This study will evaluate the long-term effects of semaglutide, a medication approved for type 2 diabetes and obesity, as an add-on treatment for patients with schizophrenia who are taking clozapine or olanzapine, focusing on its impact on metabolic health over 26 weeks.
With 104 participants aged 18-65, the trial aims to measure changes in HbA1c levels, body weight, and various metabolic markers, providing insights into whether semaglutide can mitigate the weight gain and metabolic disturbances associated with these antipsychotic medications.
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).Sass, MR., Danielsen, AA., Kรถhler-Forsberg, O., et al.[2023]
Semaglutide 2.4 mg led to significant weight loss in adults with overweight/obesity, achieving a mean change of -15.7% for those on antidepressants compared to -0.2% for placebo, demonstrating its efficacy regardless of antidepressant use.
The safety profile of semaglutide was consistent with previous studies, showing a similar prevalence of adverse events between the semaglutide and placebo groups among participants taking antidepressants.
Efficacy and safety of semaglutide 2.4 mg according to antidepressant use at baseline: A post hoc subgroup analysis.Kushner, RF., Fink-Jensen, A., Frenkel, O., et al.[2023]

Citations

Semaglutide for the treatment of antipsychotic-associated weight gain in patients not responding to metformin - a case series. [2023]
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). [2023]
Efficacy and safety of semaglutide 2.4 mg according to antidepressant use at baseline: A post hoc subgroup analysis. [2023]
The use of liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis: Results of a pilot randomized, double-blind, placebo-controlled trial. [2022]
Glucagon-like peptide-1 receptor agonists for antipsychotic-associated cardio-metabolic risk factors: A systematic review and individual participant data meta-analysis. [2019]
High-Dose Once-Weekly Semaglutide: A New Option for Obesity Management. [2022]
Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. [2023]
Semaglutide for the treatment of obesity. [2023]
Semaglutide-eye-catching results. [2023]
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