NCT07342764

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
32mo left

Started Apr 2026

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Dec 2028

First Submitted

Initial submission to the registry

January 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

January 6, 2026

Last Update Submit

January 6, 2026

Conditions

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

Keywords

DapagliflozinMetforminAntipsychotic-induced weight gainSchizophreniaPsychotic disordersRandomized controlled trialWeight managementMetabolic side effectsLifestyle interventionSGLT2 inhibitor

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Body Weight

    Percentage change in body weight from baseline to week 26, measured using a calibrated digital scale. This assesses whether dapagliflozin or metformin combined with lifestyle modification reduces antipsychotic-induced weight gain compared to lifestyle modification alone.

    26 weeks

Secondary Outcomes (7)

  • Change in Body Mass Index (BMI)

    26 weeks

  • Change in Waist Circumference

    26 weeks

  • Change in Fasting Plasma Glucose

    26 weeks

  • Change in Glycated Hemoglobin (HbA1c)

    26 weeks

  • Change in Lipid Profile

    26 weeks

  • +2 more secondary outcomes

Study Arms (3)

Arm A

ACTIVE COMPARATOR
Drug: Metformin (1000 mg Twice a day)Other: Lifestyle Modification Program

Arm B

EXPERIMENTAL
Drug: Dapagliflozin 10 mgOther: Lifestyle Modification Program

Arm C

OTHER

Control

Other: Lifestyle Modification Program

Interventions

Metformin (1000 mg Twice a day)DRUG

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

Arm A
Dapagliflozin 10 mgDRUG

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

Arm B
Lifestyle Modification ProgramOTHER

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

Arm AArm BArm C

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 16 years or older.
  • Diagnosis of a schizophrenia spectrum or other psychotic disorder according to DSM-5 (excluding substance/medication-induced or medical-condition-related psychoses, catatonia due to another disorder, or unspecified catatonia).
  • On stable antipsychotic monotherapy for at least 3 months before enrollment.
  • Evidence of antipsychotic-induced weight gain, defined as:
  • ≥7% increase in body weight from pre-treatment baseline, or
  • Body Mass Index (BMI) \>25 kg/m² with documented antipsychotic-related weight gain.
  • Stable psychiatric symptoms, judged clinically able to give informed consent and participate in the study.

You may not qualify if:

  • Diabetes mellitus (type 1 or type 2).
  • Renal impairment (estimated glomerular filtration rate \<45 mL/min/1.73 m²), hepatic disease, or other serious medical illness.
  • Pregnancy or breastfeeding.
  • Use of weight-loss medications or programs within the past 3 months.
  • Known hypersensitivity to metformin or dapagliflozin.
  • Unstable psychiatric condition or active substance use disorder likely to interfere with adherence or follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SQU

Muscat, Oman

Location

Related Publications (9)

  • Ferreira-Hermosillo A, Molina-Ayala MA, Molina-Guerrero D, Garrido-Mendoza AP, Ramirez-Renteria C, Mendoza-Zubieta V, Espinosa E, Mercado M. Efficacy of the treatment with dapagliflozin and metformin compared to metformin monotherapy for weight loss in patients with class III obesity: a randomized controlled trial. Trials. 2020 Feb 14;21(1):186. doi: 10.1186/s13063-020-4121-x.

    PMID: 32059692BACKGROUND

  • Bolinder J, Ljunggren O, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab. 2014 Feb;16(2):159-69. doi: 10.1111/dom.12189. Epub 2013 Aug 29.

    PMID: 23906445BACKGROUND

  • Bolinder J, Ljunggren O, Kullberg J, Johansson L, Wilding J, Langkilde AM, Sugg J, Parikh S. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab. 2012 Mar;97(3):1020-31. doi: 10.1210/jc.2011-2260. Epub 2012 Jan 11.

    PMID: 22238392BACKGROUND

  • Mansuri Z, Makani R, Trivedi C, Adnan M, Vadukapuram R, Rafael J, Lodhi A, Reddy A. The role of metformin in treatment of weight gain associated with atypical antipsychotic treatment in children and adolescents: A systematic review and meta-analysis of randomized controlled trials. Front Psychiatry. 2022 Nov 15;13:933570. doi: 10.3389/fpsyt.2022.933570. eCollection 2022.

    PMID: 36458118BACKGROUND

  • Hegde NC, Mishra A, Maiti R, Mishra BR, Mohapatra D, Srinivasan A. Pharmacological interventions for antipsychotic-induced weight gain in schizophrenia: A network meta-analysis. Gen Hosp Psychiatry. 2024 Sep-Oct;90:12-21. doi: 10.1016/j.genhosppsych.2024.06.003. Epub 2024 Jun 11.

    PMID: 38878592BACKGROUND

  • de Silva VA, Suraweera C, Ratnatunga SS, Dayabandara M, Wanniarachchi N, Hanwella R. Metformin in prevention and treatment of antipsychotic induced weight gain: a systematic review and meta-analysis. BMC Psychiatry. 2016 Oct 3;16(1):341. doi: 10.1186/s12888-016-1049-5.

    PMID: 27716110BACKGROUND

  • Dayabandara M, Hanwella R, Ratnatunga S, Seneviratne S, Suraweera C, de Silva VA. Antipsychotic-associated weight gain: management strategies and impact on treatment adherence. Neuropsychiatr Dis Treat. 2017 Aug 22;13:2231-2241. doi: 10.2147/NDT.S113099. eCollection 2017.

    PMID: 28883731BACKGROUND

  • Musil R, Obermeier M, Russ P, Hamerle M. Weight gain and antipsychotics: a drug safety review. Expert Opin Drug Saf. 2015 Jan;14(1):73-96. doi: 10.1517/14740338.2015.974549. Epub 2014 Nov 15.

    PMID: 25400109BACKGROUND

  • Barton BB, Segger F, Fischer K, Obermeier M, Musil R. Update on weight-gain caused by antipsychotics: a systematic review and meta-analysis. Expert Opin Drug Saf. 2020 Mar;19(3):295-314. doi: 10.1080/14740338.2020.1713091. Epub 2020 Mar 12.

    PMID: 31952459BACKGROUND

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic DisordersSchizophreniaPsychotic Disorders

Interventions

Metformindapagliflozin

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Mohammed Al Alawi, MD, PhD

    Sultan Qaboos University

    STUDY CHAIR

Central Study Contacts

Said Ahmed Al Farsi, MD

CONTACT

00968 95783006said.alfarsi96@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant and Assistant Professor

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 15, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

OM(1)