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

The University of Nigeria Teaching Hospital

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT07297290

2024CWR-LMIC-981332295

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 20 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 2 patient groups, including a placebo group

Treatment arm

Experimental group

Description:

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

Treatment:

Drug: Metformin

Control arm

Placebo Comparator group

Description:

Identical-looking placebo

Treatment:

Drug: Placebo