Effect of Metformin, a Drug Used to Treat Diabetes, vs Placebo

About

Brief Summary

Metformin is a drug used to treat patients with diabetes. The aim of this study is to examine the effect of Metformin along with a low-calorie diet on obese and/or overweight adults with an increased waist measurement. In addition, the study also aims to look at the effect of the drug vs. placebo on quality of life and physical activity.

Primary Purpose

Prevention

Study Type

Interventional

Phase

Phase 3/Phase 4

Eligibility

Gender

All

Healthy Volunteers

Yes

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

Male or female, age ≥ 18 years at the time of signing informed consent.
Body Mass Index (BMI) ≥ 27 kg/m2
Waist circumference >40" for men, and >35" for women

Exclusion Criteria:

A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Diagnosed with T2D (HbA1c >7.5 (53 mmol/mol)
Current use of insulin or oral medication of metformin, SU, SGLT2i, glitazone, DPP4 or GLP-1 agonist injections as single agent therapy or combination oral agents.
Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 45 mL/min/1.73 m2 (< 60 ml/min/1.73 m2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 201242 by the central laboratory at screening
History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months (History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable).
History or lactic acidosis
Liver problems
Congestive heart failure
History of alcoholism
Recent surgery
Heart attack, severe infection or stroke
Any unstable medical conditions or terminal diagnosis
Pregnancy or lactation
Allergy and intolerance to metformin