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

Sponsor
Oman Ministry of Health
Study ID
NCT06000462
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Dapagliflozin Adverse Reaction
  • Effect of Drug
  • Obesity
  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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).

Key Dates

Start date
Apr 22, 2024
Status verified
Mar 2025
Primary completion
Aug 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    10 mg strength will be used in this study. The drug is usually taken orally once a day, preferably in the morning. The participants will be using the medication for 32 weeks only, then continue follow up for another 16 weeks (off drug therapy) with behavior weight management program only. The patients will be informed from the beginning of the study with the general side effects of medication (patient information sheet) that should be reported if experienced.
  • Active Comparator: Metformin
    1000 mg strength will be used once daily dose taken orally. Medication will be provided randomly to the patient according to the corresponding number. The patients are informed to declare any experienced side effects that has been stated in the patient information sheet without informing the name of drugs.
  • Placebo Comparator: Placebo
    receive a non-medicated pill that has no therapeutic effect, once daily.

Primary Outcome Measure

Difference in inter-arms percent of subjects achieving ≥5% reduction in baseline weight [ Time Frame: 32 weeks post randomization ]

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