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Can a diabetes drug shield the hearts of people with schizophrenia?

NCT ID NCT07770282

Disease control Sponsor: All India Institute of Medical Sciences, Bhubaneswar Source: ClinicalTrials.gov ↗

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests whether adding semaglutide—a medication used for diabetes and weight management—to standard antipsychotic treatment can lower the 10-year risk of heart attack and stroke in people with schizophrenia who also have metabolic syndrome. The study will measure changes in cardiovascular risk scores, insulin resistance, cholesterol, and weight over 24 weeks. It aims to find a safe and effective way to address the high rates of heart disease in this population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
semaglutide (oral tablet) added to usual antipsychotic treatment
What this could lead to
If effective, this could offer a new way to reduce heart attack and stroke risk in people with schizophrenia who have metabolic syndrome, potentially improving overall health and longevity.
What could go wrong
This is a phase 3 trial, but results may not be conclusive or may not apply to everyone. Semaglutide can cause gastrointestinal side effects, and its psychiatric safety needs confirmation.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Clinically diagnosed schizophrenia (ICD-11) on a second-generation antipsychotic (SGA) for more than 6 months. * Metabolic syndrome per NCEP ATP III definition. * Aged above 25 years, any gender. * Patient / Legally Authorised Representative (LAR) provides voluntary written informed consent. Exclusion Criteria: * ● On clozapine, aripiprazole, or a combination of SGAs. * Any contraindication to semaglutide. * Comorbid severe psychiatric, medical or neurological disorder. * History of organicity or significant head injury. * Pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome Insulin Resistance metabolic syndrome X schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antipsychotic induced weight gain Cardiovascular risk Insulin resistance Metabolic syndrome Schizophrenia disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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