Obesity and Cardiovascular RiskPhase 3MOWRINCT07297290
Effect of Metformin Use on Weight Loss in Obese, Non-diabetic People (MOWRI)
A Phase 3 study testing Metformin in people with Obesity and Cardiovascular Risk and Insulin Resistance, run by University Of Nigeria Teaching Hospital at 2 sites in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- Obesity and Cardiovascular Risk, Insulin Resistance, Obesity (Body Mass Index >30 kg/m2)
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 2 sitesNigeria
- Study dates
- 23 Jul 2025to 30 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria2 sites, 2 recruiting
- Recruiting
Pathology Facility
Enugu, Enugu State
Emeka F Nnakenyi, MD, +2348139427709, pathologyfacility@gmail.com
- Recruiting
University of Nigeria Teaching Hospital
Enugu, Enugu State
Obinna D Onodugo, MD, +2348035899750, obiokwesili@gmail.com
About this study
Official title: 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.
- Conditions
- Obesity and Cardiovascular Risk, Insulin Resistance, Obesity (Body Mass Index >30 kg/m2)
- Being tested
- Metformin, Placebo
- Keywords
- Obesity, Metformin use, Weight loss, Non-diabetic
- Medical subject headings
- Obesity, Insulin Resistance, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin 500mg extended release tablets taken to a maximum of 1500mg once daily
PlaceboDrug
Starch-based, identical looking placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Metformin 500mg extended release tablets taken once daily to a maximum dose of 1500mg daily Receives: Drug: Metformin |
| Control arm | Placebo comparator | Identical-looking placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start23 Jul 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Cardiovascular RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Nigeria Teaching Hospital
- Sponsor type
- Research network
- Collaborators
- Cures Within Reach
- Responsible party
- Principal investigator, Ifeyinwa Nnakenyi, University Of Nigeria Teaching Hospital
- Investigators
- IFEYINWA D NNAKENYI, MD, Principal investigator, University Of Nigeria Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297290
- Sponsor's protocol ID
- 2024CWR-LMIC-981332295
- Acronym
- MOWRI
- Status last verified
- Dec 2025
- First submitted
- 1 Sep 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, statistical analysis plan, informed consent form, Non-identifiable patient measurements.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metformin Use on Weight Loss in Obese, Non-diabetic People
- ClinicalTrials.gov ID
- NCT07297290
- Acronym / sponsor ID
- MOWRI / 2024CWR-LMIC-981332295
- Conditions
- Obesity and Cardiovascular Risk, Insulin Resistance, Obesity (Body Mass Index >30 kg/m2)
- Keywords
- Obesity, Metformin use, Weight loss, Non-diabetic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Of Nigeria Teaching HospitalResearch network
- Collaborators
- Cures Within Reach
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: MetforminMetformin 500mg extended release tablets taken once daily to a maximum dose of 1500mg daily |
| Control arm | Placebo comparator | Drug: PlaceboIdentical-looking placebo |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Obesity (defined as body mass index ≥ 30kg/m2),
Key exclusion criteria (4 listed)
- • Obesity (defined as body mass index ≥ 30kg/m2),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin 500mg extended release tablets taken to a maximum of 1500mg once daily | Drug | Treatment arm |
| PlaceboStarch-based, identical looking placebo | Drug | Control arm |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Safety of Metformin extended release tablet taken daily
Time frame: 24 months
Percent drug compliance to Metformin extended release taken once daily.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes. Study protocol, statistical analysis plan, informed consent form, Non-identifiable patient measurements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
IFEYINWA D NNAKENYI, MD principal investigator
University Of Nigeria Teaching Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin in people with Obesity and Cardiovascular Risk and Insulin Resistance, run by University Of Nigeria Teaching Hospital at 2 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiamaka C Onu, BSc (+2347031800855, mowri2025@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Metformin on body weight change (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.