NCT06000462Active, not recruitingPhase 4
The Effect of Dapagliflozin on Weight Loss in Obese Adults Without Diabetes
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.
Source: ClinicalTrials.gov · Last updated 26 Mar 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 14 Aug 2023
- Start date
- 22 Apr 2024
- Primary completion date
- 30 Aug 2025
- Lead sponsor
- Oman Ministry of Health
- Diseases
- Obesity
- NCT number
- NCT06000462
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- From 22 Apr 2024 to the primary completion date, 30 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with medications within 90 days before screening that, that are used in obesity treatment including pramlintide, orlistat, zonisamide, topiramate, lorcaserin, phentermine, bupropion, naltrexone, glucagon-like peptide-1 (GLP-1) receptor agonists, or metformin (used as treatment for obesity)
- Patients with recurrent urinary tract infection or fungal infections within 12 months before screening
Other illness
- Type 1 or type 2 diabetes mellitus (T1DM)
- Patients with peripheral vascular disease
- History of major depressive disorder within 2 years before screening
- History of cardiopulmonary diseases that prevents from physical activity
Lab values
- Patients with impaired kidney function including persistent eGFR \<= 45 and albuminuria
Other
- Subjects with secondary causes of obesity (i.e., hypothalamic, genetic, or endocrine causes)
- On anti-diabetic treatment
- Pregnancy
Who the study is looking for
- BMI 30-40 mg/kg2 for adults by international cut-off points (for diagnosis of obesity)
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- Stable body weight during the previous 90 days before screening (\<5 kg self-reported weight change)
- History of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject's medical record.
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bawsher Health Center Coordinator of this site? Confirm its status | Bawhser | Oman | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.