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

NCT06000462 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: OmanMOH
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 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

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

Keywords

Sodium glucose co transporter inhibitor 2; Dapagliflozin; weight reduction; obesity; young adult; SGLT2I; weight loss

Outcome Measures

Primary Outcomes (2)

• Difference in inter-arms percent of subjects achieving ≥5% reduction in baseline weight

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

  32 weeks post randomization

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

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

  32 weeks post randomization

Secondary Outcomes (2)

• Inter-arms group mean difference in metabolic parameters, depression, anxiety

  32 weeks post randomization

• Frequency of adverse event from dapagliflozin

  32 weeks post randomization

Study Arms (3)

Dapagliflozin

EXPERIMENTAL

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.

Drug: Dapagliflozin 10mg Tab

Metformin

ACTIVE COMPARATOR

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.

Drug: Metformin 1000 mg (ttd)

Placebo

PLACEBO COMPARATOR

receive a non-medicated pill that has no therapeutic effect, once daily.

Other: Placebo

Interventions

Dapagliflozin 10mg Tab DRUG

Mentioned in detailed description.

Also known as: Forxiga

Dapagliflozin

Metformin 1000 mg (ttd) DRUG

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

Also known as: Glucophage

Metformin

Placebo OTHER

a non-medicated pill will be used as a placebol

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oman Ministry of Health: lead

Study Sites (1)

Bawsher Health Center

Bawhser, Muḩāfaz̧at Masqaţ, 000, Oman

Location

Related Publications (12)

• Lin X, Li H. Obesity: Epidemiology, Pathophysiology, and Therapeutics. Front Endocrinol (Lausanne). 2021 Sep 6;12:706978. doi: 10.3389/fendo.2021.706978. eCollection 2021.

  PMID: 34552557 BACKGROUND

• WHO. Obesity and Overweight. 2018. 23 Feb 2020. Contract No.: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight.

  BACKGROUND

• GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.

  PMID: 33069326 BACKGROUND

• Al-Mawali A, Jayapal SK, Morsi M, Al-Shekaili W, Pinto AD, Al-Kharusi H, Al-Harrasi A, Al-Balushi Z, Idikula J. Prevalence of risk factors of non-communicable diseases in the Sultanate of Oman: STEPS survey 2017. PLoS One. 2021 Oct 28;16(10):e0259239. doi: 10.1371/journal.pone.0259239. eCollection 2021.

  PMID: 34710161 BACKGROUND

• Look AHEAD Research Group; Wing RR. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch Intern Med. 2010 Sep 27;170(17):1566-75. doi: 10.1001/archinternmed.2010.334.

  PMID: 20876408 BACKGROUND

• Food U, Administration D. FDA Approves New Drug Treatment for Chronic Weight Management: First Since 2014. Washington, DC Center for Drug Evaluation and Research. 2021.

  BACKGROUND

• Yumuk V, Tsigos C, Fried M, Schindler K, Busetto L, Micic D, Toplak H; Obesity Management Task Force of the European Association for the Study of Obesity. European Guidelines for Obesity Management in Adults. Obes Facts. 2015;8(6):402-24. doi: 10.1159/000442721. Epub 2015 Dec 5.

  PMID: 26641646 BACKGROUND

• DeFronzo RA, Davidson JA, Del Prato S. The role of the kidneys in glucose homeostasis: a new path towards normalizing glycaemia. Diabetes Obes Metab. 2012 Jan;14(1):5-14. doi: 10.1111/j.1463-1326.2011.01511.x.

  PMID: 21955459 BACKGROUND

• Liu XY, Zhang N, Chen R, Zhao JG, Yu P. Efficacy and safety of sodium-glucose cotransporter 2 inhibitors in type 2 diabetes: a meta-analysis of randomized controlled trials for 1 to 2years. J Diabetes Complications. 2015 Nov-Dec;29(8):1295-303. doi: 10.1016/j.jdiacomp.2015.07.011. Epub 2015 Jul 21.

  PMID: 26365905 BACKGROUND

• Gallo LA, Wright EM, Vallon V. Probing SGLT2 as a therapeutic target for diabetes: basic physiology and consequences. Diab Vasc Dis Res. 2015 Mar;12(2):78-89. doi: 10.1177/1479164114561992. Epub 2015 Jan 23.

  PMID: 25616707 BACKGROUND

• Michel MC, Mayoux E, Vallon V. A comprehensive review of the pharmacodynamics of the SGLT2 inhibitor empagliflozin in animals and humans. Naunyn Schmiedebergs Arch Pharmacol. 2015 Aug;388(8):801-16. doi: 10.1007/s00210-015-1134-1. Epub 2015 Jun 26.

  PMID: 26108304 BACKGROUND

• Baker WL, Smyth LR, Riche DM, Bourret EM, Chamberlin KW, White WB. Effects of sodium-glucose co-transporter 2 inhibitors on blood pressure: a systematic review and meta-analysis. J Am Soc Hypertens. 2014 Apr;8(4):262-75.e9. doi: 10.1016/j.jash.2014.01.007. Epub 2014 Jan 26.

  PMID: 24602971 BACKGROUND

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

dapagliflozin; Metformin; Disulfiram

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Ditiocarb; Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Disulfides; Sulfides; Sulfur Compounds

Study Officials

• Thuraiya Al Harthi, Masters

  Oman MoH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To blind the care providers, investigators, and participants,150 packs of medication labelled from 1 to 150 numbered randomly from 1-150 (but this depends on number of patients who did not respond to run in period intervention), 50 each containing either 10 mg dapagliflozin or 1000mg metformin or the placebo. The label on the pack only has the serial number but the pharmacist (who is not part of this study) has the code of what each bottle contains and that is kept safely and confidentially (Hard copy and multiple soft copies in safe custody). Participants are numbered serially according to recruitment, and each gets the correspondingly numbered bottle (which has been previously randomly assigned by the pharmacist).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Epidemiologist

Model Details: Triple-blind, parallel groups, randomized, placebo control trial

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: April 22, 2024
• Primary Completion: August 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 24 months
• Access Criteria: principal investigator Research assistant Care providers Statistician

Locations

OM (1)