Effect of Metformin Use on Weight Loss in Obese, Non-diabetic People (MOWRI) (MOWRI)

Effect of Metformin Use on Weight Loss in Obese, Non-diabetic People

Obesity is a chronic disease of global public health concern, contributing to cardiovascular disease, type 2 diabetes and certain cancers. Currently approved anti-obesity drugs and surgery are expensive and not readily available in Nigeria.

Metformin, approved for type 2 diabetes, has been shown to promote weight loss among obese patients in high income countries. However, metformin's effects have not yet been demonstrated in Black African populations, which may have different genetic and environmental predispositions to obesity and to the effect of metformin. This blinded, placebo-controlled, randomized trial is determining the effect of metformin on weight loss, cardiovascular disease risk and insulin resistance in Black Nigerians.

Study Overview

• Status: Recruiting
• Conditions: Insulin Resistance; Obesity and Cardiovascular Risk; Obesity (Body Mass Index >30 kg/m2)
• Intervention / Treatment: Drug: Metformin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chiamaka C Onu, BSc; Phone Number: +2347031800855; Email: mowri2025@gmail.com

Study Locations

• Nigeria
  • Enugu State
    • Enugu, Enugu State, Nigeria
      • Recruiting
      • University of Nigeria Teaching Hospital
      • Contact: Obinna D Onodugo, MD; Phone Number: +2348035899750; Email: obiokwesili@gmail.com
    • Enugu, Enugu State, Nigeria
      • Recruiting
      • Pathology Facility
      • Contact: Emeka F Nnakenyi, MD; Phone Number: +2348139427709; Email: pathologyfacility@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Obesity (defined as body mass index ≥ 30kg/m2),

  • Fasting plasma glucose (<7.0mmol/L)
  • No medical treatment for weight control in the previous 12 months
  • No participation in a current clinical trial

Exclusion Criteria:

• • Obesity (defined as body mass index ≥ 30kg/m2),

  • Fasting plasma glucose (<7.0mmol/L)
  • No medical treatment for weight control in the previous 12 months
  • No participation in a current clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; Metformin 500mg extended release tablets taken once daily to a maximum dose of 1500mg daily	Drug: Metformin; Metformin 500mg extended release tablets taken to a maximum of 1500mg once daily
Placebo Comparator: Control arm; Identical-looking placebo	Drug: Placebo; Starch-based, identical looking placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Metformin on body weight change	Determine percent change in body weight in kilograms and height in meters which will be combined to report BMI in kg/m2 among the treatment arm and compared to the control arm.	24 months
Effect of Metformin on Cardiovascular risk	Determine percent change in the 10 year Framingham risk score for cardiovascular disease among the treatment arm and compare with the control arm.	24 months
Effect of Metformin on insulin resistance in non-diabetics	Determine percent change in the insulin resistance indices using Homeostatic model assessment (HOMA) among the treatment arm and compare to the control arm.	24 months
Effect of metformin on waist circumference change	Determine the percent change in waist circumference measured in cm at baseline and final readings among the treatment arm and compared to the control arm.	24 months
Effect of metformin on waist-to-hip circumference change	Determine the percent change in waist circumference measured in cm, and hip circumference measured in cm, which will be combined to report waist-to-hip circumference ratio change among the treatment arm and compared to the control arm.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Metformin extended release tablet taken daily	Determine the incidence of adverse effects at grade 3 or higher level using the Adverse Effect questionnaire when dosage of less than or equal to 1500mg of Metformin X extended release tablet is taken daily.	24 months
Percent drug compliance to Metformin extended release taken once daily.	Determine the percent drug compliance to administered Metformin extended release tablets, determined by count of actual number of drug tablets administered over count of what was expected to have been administered, expressed as a percentage.	24 months

Collaborators and Investigators

• Sponsor: University Of Nigeria Teaching Hospital
• Collaborators: Cures Within Reach
• Investigators: Principal Investigator: IFEYINWA D NNAKENYI, MD, University of Nigeria Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: September 1, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Weight loss; Non-diabetic; Metformin use
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Body Weight Changes; Glucose Metabolism Disorders; Hyperinsulinism; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Weight Loss; Insulin Resistance; Organic Chemicals; Biguanides; Guanidines; Amidines; Metformin
• Other Study ID Numbers: 2024CWR-LMIC-981332295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol, statistical analysis plan, informed consent form, Non-identifiable patient measurements.
• IPD Sharing Time Frame: IPD will be made available after publishing of the research work likely from 1 Jan 2029 for 5 years (31 Dec 2033)
• IPD Sharing Access Criteria: The research institution, the research funders, potential collaborators and funders.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No