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

NCT07297290 | Recruiting Phase 3

• 1 other identifier: 2024CWR-LMIC-981332295
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Insulin Resistance; Obesity and Cardiovascular Risk; Obesity (Body Mass Index >30 kg/m2)

Keywords

Obesity; Metformin use; Weight loss; Non-diabetic

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Safety of Metformin extended release tablet taken daily

  24 months

• Percent drug compliance to Metformin extended release taken once daily.

  24 months

Study Arms (2)

Treatment arm

EXPERIMENTAL

Metformin 500mg extended release tablets taken once daily to a maximum dose of 1500mg daily

Drug: Metformin

Control arm

PLACEBO COMPARATOR

Identical-looking placebo

Drug: Placebo

Interventions

Metformin DRUG

Metformin 500mg extended release tablets taken to a maximum of 1500mg once daily

Treatment arm

Placebo DRUG

Starch-based, identical looking placebo

Control arm

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cures Within Reach: collaborator
• University Of Nigeria Teaching Hospital: lead

Study Sites (2)

Pathology Facility

Enugu, Enugu State, Nigeria

RECRUITING

University of Nigeria Teaching Hospital

Enugu, Enugu State, Nigeria

RECRUITING

MeSH Terms

Conditions

Obesity; Insulin Resistance; Weight Loss

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• IFEYINWA D NNAKENYI, MD

  University Of Nigeria Teaching Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiamaka C Onu, BSc

CONTACT

+2347031800855; mowri2025@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Blinded Pharmacist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Chemical Pathologist and Metabolic Physician

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: December 22, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available after publishing of the research work likely from 1 Jan 2029 for 5 years (31 Dec 2033)
• Access Criteria: The research institution, the research funders, potential collaborators and funders.

Locations

NG (2)