Can a diabetes drug beat metformin for antipsychotic weight gain?
NCT ID NCT07342764
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares dapagliflozin and metformin for managing weight gain caused by antipsychotic medications. About 110 adults aged 16 and older will take one of the drugs plus lifestyle advice for 26 weeks. The goal is to see which drug works better and is safer for weight control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dapagliflozin and metformin
- What this could lead to
- If it works, this could offer a new option to help people taking antipsychotics manage weight gain, improving their overall health.
- What could go wrong
- This is a small pilot study, so results may not apply to everyone. Side effects like dehydration or stomach issues are possible.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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
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16 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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: * Patients aged ≥16 years * Diagnosis according to DSM-5 criteria, including: Schizophrenia spectrum and other psychotic disorders, as summarized in the DSM-5 chapter Schizophrenia Spectrum and Other Psychotic Disorders, excluding: Substance/medication-induced psychotic disorder Psychotic disorder due to another medical condition Catatonia associated with another mental disorder Catatonic disorder due to another medical condition Unspecified catatonia Bipolar and related disorders, as summarized in the DSM-5 chapter Bipolar and Related Disorders Depressive disorders, as summarized in the DSM-5 chapter Depressive Disorders Obsessive-compulsive and related disorders, as summarized in the DSM-5 chapter Obsessive-Compulsive and Related Disorders Other psychiatric conditions for which antipsychotic treatment is clinically indicated, as judged by the investigator Other conditions where antipsychotics are indicated * Receiving stable antipsychotic treatment for ≥3 months prior to enrollment * Evidence of antipsychotic-induced weight gain (AiWG), defined as: 1. ≥7% increase in body weight from baseline following initiation of antipsychotic treatment, or 2. BMI \>25 kg/m² with clinically established antipsychotic-associated weight gain * Able to understand and comply with study procedures, as judged by the investigator * Able to provide written informed consent. For participants aged 16-17 years, assent and/or guardian consent will be obtained according to local ethics committee requirements. Exclusion criteria: * Diabetes mellitus * Diagnosed patients of polycystic ovarian syndrome (PCOS) * Renal impairment defined as estimated glomerular filtration rate (eGFR \<45 mL/min/1.73 m²) * Significant hepatic disease or other serious or unstable medical conditions that, in the opinion of the investigator, would make participation unsafe * Pregnant or breastfeeding females * Current use of metformin, dapagliflozin, or another sodium-glucose cotransporter 2 inhibitor. * Use of weight-loss medications or participation in structured weight-loss programs within the past 3 months * Recurrent genitourinary infections (if dapagliflozin is used) * Use of non-antipsychotic medications known to cause clinically significant weight gain, including but not limited to selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), mirtazapine, tricyclic antidepressants, valproate, lithium, corticosteroids, sedating antihistamines, or other medications as judged by the investigator * Unstable psychiatric condition or active substance use disorder that may impair the ability to adhere to study procedures, as judged by the investigator
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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SQU
Muscat, Oman
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