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NCT Number: NCT07297290

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

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.

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Key information

Conditions

Obesity and Cardiovascular Risk Body Weight Body Weight Changes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity (Body Mass Index >30 kg/m2) Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pathology Facility, Enugu, Enugu State, Nigeria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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

Placebo

Drug

Starch-based, identical looking placebo

Primary outcomes

  1. Effect of Metformin on body weight change

    Time frame: 24 months

    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.

  2. Effect of Metformin on Cardiovascular risk

    Time frame: 24 months

    Determine percent change in the 10 year Framingham risk score for cardiovascular disease among the treatment arm and compare with the control arm.

  3. Effect of Metformin on insulin resistance in non-diabetics

    Time frame: 24 months

    Determine percent change in the insulin resistance indices using Homeostatic model assessment (HOMA) among the treatment arm and compare to the control arm.

  4. Effect of metformin on waist circumference change

    Time frame: 24 months

    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.

  5. Effect of metformin on waist-to-hip circumference change

    Time frame: 24 months

    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.

Secondary outcomes

  1. Safety of Metformin extended release tablet taken daily

    Time frame: 24 months

    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.

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

    Time frame: 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chiamaka C Onu, BSc

CONTACT

[email protected]

+2347031800855

Sponsors and collaborators

Lead sponsor

University Of Nigeria Teaching Hospital

Network

Collaborators

  • Cures Within Reach

Registry information

Official study title

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

Acronym: MOWRI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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