Clinical trial

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

Active, not recruiting · Phase 4 · 1 countries · Registry ID NCT06000462

Active, not recruitingPhase 4Interventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 50 Years

SexAll

Healthy volunteersAccepted

ConditionObesity, Dapagliflozin Adverse Reaction, Weight Loss, Effect of Drug

Full registry criteria

Inclusion Criteria: * 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 Criteria: * 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

Treatments and study arms

Dapagliflozin 10mg Tab

Drug

Mentioned in detailed description.

Metformin 1000 mg (ttd)

Drug

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

Placebo

Other

a non-medicated pill will be used as a placebol

Primary outcomes

Difference in inter-arms percent of subjects achieving ≥5% reduction in baseline weight32 weeks post randomization

we will measure the percentage change of weight in terms of achieving 5 or more and compare it with other arms

Inter-arms differences in mean BMI, waist circumference, waist hip ratio, body weight (kilogram, kg), Body fat (%), and Muscle mass (%)32 weeks post randomization

we will measure the intra-group mean difference from baseline and then compares the intergroup mean difference.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Bawsher Health Center🌐 Bawhser, Muḩāfaz̧at Masqaţ, Oman

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