Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a diabetes drug help schizophrenia patients lose weight?

NCT ID NCT05333003

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Aug 2026

An estimate. End dates often move.

Lead sponsor

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

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

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)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Bipolar disorder are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.