Clinical Trial

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

Study acronym: DAPA-ANDO
Active, Not Recruiting Phase 4
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Record status
This record was last updated March 26, 2025 (before its estimated August 30, 2025 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-08-14; most recent amendment 2025-03-23.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-02-15
Trial Details
NCT Number NCT06000462
Lead Sponsor Oman Ministry of Health
Conditions Obesity, Dapagliflozin Adverse Reaction, Weight Loss, Effect of Drug
Enrollment 150 participants
Start Date 2024-04-22
Primary Completion 2025-08-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-26