Could a diabetes drug help schizophrenia patients lose weight?
NCT ID NCT05333003
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether semaglutide, a drug used for diabetes and weight loss, can help people with schizophrenia who are overweight or obese and did not lose weight on metformin. About 92 participants will receive either semaglutide or a placebo. The main goal is to see if semaglutide leads to significant weight loss.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- semaglutide
- What this could lead to
- If it works, this could offer a new weight-loss option for people with schizophrenia who haven't had success with metformin.
- What could go wrong
- This is a small, early-stage trial with no phase designation. The results may not apply to everyone, and semaglutide can cause side effects like nausea or vomiting.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 92 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2022
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Stable outpatients or inpatients aged 18-70 years, diagnosed with schizophrenia spectrum disorder, or major depressive disorder with psychotic features, or bipolar disorder (does not need to have psychotic features) * On maintenance treatment with an AP (stable dose for ≥3 months) * BMI must be ≥30 kg/m2, OR ≥27 kg/m2 with the presence of at least one weight-related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnea, or impaired fasting glucose, OR BMI ≥25 with individual having gained \>5% bodyweight in association with AP treatment * History of either failure to tolerate metformin or failure to lose ≥5% body weight over at least 16 weeks on the highest tolerated trial of metformin, and who are not currently being treated with metformin (minimum of 1 week metformin-free prior to study entry) Exclusion Criteria: * Patients with severe substance disorder other than tobacco or caffeine use disorder; only severe substance use disorder is exclusionary for cannabis use * Liver, or renal dysfunction * A positive drug urine screen other than cannabis as per PI discretion * Sexually active females of child-bearing age not on a regular contraceptive, or nursing or with a positive pregnancy test * Clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, or pulmonary disease * History of reactive hypoglycaemia * Treatment within 3 months, or failure to tolerate GLP-1RA * Type 1 Diabetes (T1D) or current diagnosis of Type 2 Diabetes (T2D), diagnosis of T2D on OGTT screen, or HbA1c \> 6.5% * Use of Health Canada approved weight-lowering agents, warfarin, coumarin derivatives, or medication with significant renal impact * Major medical or surgical event within the preceding 3 months * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome * History of pancreatitis or elevated amylase on screen * History of severe gastrointestinal disease, (i.e. gastroparesis) * Acute suicidal risk * Uncompensated thyroid disorder * History of heart rhythm disturbances, conduction system abnormalities, or evidence of clinically relevant abnormalities on screening ECG. * 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) * History of gallstones with intact gallbladder or those at increased risk of gallbladder complications (with intact gallbladder)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4, Canada
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