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

NCT06000462 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-03-26

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Dapagliflozin 10mg Tab

Mentioned in detailed description.

DRUG

Metformin 1000 mg (ttd)

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

OTHER

Placebo

a non-medicated pill will be used as a placebol

Sponsors & Collaborators

  • Oman Ministry of Health

    lead OTHER_GOV

Principal Investigators

  • Thuraiya Al Harthi, Masters · Oman MoH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-22
Primary Completion
2025-08-30
Completion
2025-12-30

Countries

  • Oman

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06000462 on ClinicalTrials.gov