MedDataX Logo

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

NCT ID: NCT07297290

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-23

Study Completion Date

2027-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Obesity Metformin use Weight loss Non-diabetic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Blinded Pharmacist

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment arm

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

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

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

Control arm

Identical-looking placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Starch-based, identical looking placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metformin

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

Intervention Type DRUG

Placebo

Starch-based, identical looking placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cures Within Reach

OTHER

Sponsor Role collaborator

University Of Nigeria Teaching Hospital

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ifeyinwa Nnakenyi

Consultant Chemical Pathologist and Metabolic Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

IFEYINWA D NNAKENYI, MD

Role: PRINCIPAL_INVESTIGATOR

University Of Nigeria Teaching Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pathology Facility

Enugu, Enugu State, Nigeria

Site Status RECRUITING

University of Nigeria Teaching Hospital

Enugu, Enugu State, Nigeria

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Nigeria

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chiamaka C Onu, BSc

Role: CONTACT

Phone: +2347031800855

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Emeka F Nnakenyi, MD

Role: primary

Obinna D Onodugo, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024CWR-LMIC-981332295

Identifier Type: -

Identifier Source: org_study_id