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ACTIVE NOT RECRUITING
NCT06000462
PHASE4

The Effect of Dapagliflozin on Weight Loss in Obese Adults Without Diabetes

Sponsor: Oman Ministry of Health

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to examine the effectiveness of a drug named dapagliflozin (tested drug) on weight loss in young adults aged between 18 and 40 years with obesity who are not diagnosed with diabetes. The main questions this study aims to answer are: * How much weight in average can people loose with the use of tested drug compared to 2 other comparator drugs: metformin and placebo (non-medicated pill)? * What is the effect of using tested drug on other parameters used to assess metabolic disease including blood pressure, cholesterol and sugar levels, and mental health? * How frequent are the side effects from using the tested drug compared to the comparator drugs? Participants will go through a 6-month program of physical activity and diet and measure their weight progress (Run in period). Those who do not achieve the target weight reduction will be randomly assigned to any of the three drug groups, either testes drug group, comparator 1 (metformin), or comparator 2 (placebo).

Official title: The Effect of Sodium Glucose Co-transporter 2 Inhibitor (dapagliflozin) on Weight Loss in Non-diabetic Adults with Obesity: Triple-blinded, Randomized, Placebo-controlled Trial.

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-04-22

Completion Date

2025-12-30

Last Updated

2025-03-26

Healthy Volunteers

Yes

Interventions

DRUG

Dapagliflozin 10mg Tab

Mentioned in detailed description.

DRUG

Metformin 1000 mg (ttd)

A dose of 1000 mg, PO, once daily, given over 8 months period

OTHER

Placebo

a non-medicated pill will be used as a placebol

Locations (1)

Bawsher Health Center

Bawhser, Muḩāfaz̧at Masqaţ, Oman