NCT05949008Active, not recruitingPhase 4
Effect of Metformin, a Drug Used to Treat Diabetes, vs Placebo
Effect of Metformin ER With Hypocaloric Diet on Weight Loss in Overweight/Obese Patients With Increased Waist Circumference
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 13 Jun 2023
- Start date
- 22 Nov 2023
- Primary completion date
- 30 Oct 2027
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT05949008
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- From 22 Nov 2023 to the primary completion date, 30 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A self-reported change in body weight \> 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- 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.
- Recent surgery
Other illness
- 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).
- Congestive heart failure
- History of alcoholism
- Heart attack, severe infection or stroke
- Any unstable medical conditions or terminal diagnosis
- Allergy and intolerance to metformin
Lab values
- Diagnosed with T2D (HbA1c \>7.5 (53 mmol/mol)
- 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
Other
- History or lactic acidosis
- Liver problems
- Pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA Center for Human Nutrition Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.