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Comparative Effectiveness of Dapagliflozin, Metformin, and Lifestyle Modification for Antipsychotic-Induced Weight Gain: An Open-Label Pragmatic Trial

NCT07342764 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-01-15

No results posted yet for this study

Summary

Clinical trial:

The goal of this clinical trial is to learn if dapagliflozin can help reduce weight gain caused by antipsychotic medications in people with schizophrenia and related disorders. It will also assess the safety of dapagliflozin.

* The main questions it aims to answer are:

* Does dapagliflozin lower body weight compared to metformin or lifestyle changes alone?
* Does it improve blood sugar, cholesterol, and overall health?
* Researchers will compare three groups:

* Dapagliflozin plus lifestyle changes
* Metformin plus lifestyle changes
* Lifestyle changes alone
* Participants will:

* Take the assigned medication daily for 26 weeks (or follow lifestyle guidance only)
* Attend clinic visits at weeks 0, 4, 12, and 26 for measurements and blood tests
* Receive phone calls for follow-up and side effect checks

Conditions

  • Antipsychotic-induced Weight Gain (AIWG)
  • Antipsychotic-induced Weight Gain
  • Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

DRUG

Metformin (1000 mg Twice a day)

Metformin tablets starting at 500 mg twice daily and increased to 1000 mg twice daily as tolerated, taken with meals for 26 weeks.

DRUG

Dapagliflozin 10 mg

Dapagliflozin 10 mg tablet taken once daily for 26 weeks. It increases glucose excretion through urine and may lower weight.

OTHER

Lifestyle Modification Program

Participants receive a structured lifestyle program, including dietary counseling, physical-activity planning, and behavioral support at scheduled visits (weeks 0, 4, 12, and 26).

Sponsors & Collaborators

  • Sultan Qaboos University

    lead OTHER

Principal Investigators

  • Mohammed Al Alawi, MD, PhD · Sultan Qaboos University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-11-30
Completion
2028-12-31

Countries

  • Oman

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07342764 on ClinicalTrials.gov