Status:
ACTIVE_NOT_RECRUITING
The Effect of Dapagliflozin on Weight Loss in Obese Adults Without Diabetes
Lead Sponsor:
Oman Ministry of Health
Conditions:
Obesity
Dapagliflozin Adverse Reaction
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief 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 diagnos...
Detailed Description
Background Obesity is a disease, generally defined as a body mass index (BMI) ≥ 30 kg/m2,1 is a global issue that continues to grow at an alarming rate, imposing serious threat to individuals, public ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Type 1 or type 2 diabetes mellitus (T1DM)
- Subjects with secondary causes of obesity (i.e., hypothalamic, genetic, or endocrine causes)
- 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)
- On anti-diabetic treatment
- Patients with impaired kidney function including persistent eGFR \<= 45 and albuminuria
- Patients with peripheral vascular disease
- Patients with recurrent urinary tract infection or fungal infections within 12 months before screening
- History of major depressive disorder within 2 years before screening
- History of cardiopulmonary diseases that prevents from physical activity
- Pregnancy
Key Trial Info
Start Date :
April 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06000462
Start Date
April 22 2024
End Date
December 30 2025
Last Update
March 26 2025
Active Locations (1)
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1
Bawsher Health Center
Bawhser, Muḩāfaz̧at Masqaţ, Oman, 000