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The Effect of Dapagliflozin on Weight Loss in Obese Adults Without Diabetes
Sponsor: Oman Ministry of Health
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
Dapagliflozin 10mg Tab
Mentioned in detailed description.
Metformin 1000 mg (ttd)
A dose of 1000 mg, PO, once daily, given over 8 months period
Placebo
a non-medicated pill will be used as a placebol
Locations (1)
Bawsher Health Center
Bawhser, Muḩāfaz̧at Masqaţ, Oman