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

NCT05949008 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 22-001670
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

NIDDM; Obesity

Outcome Measures

Primary Outcomes (2)

• Number of participants who achieve body weight reduction ≥5% from baseline

  Percent change in body weight reduction ≥5% from baseline (week 0) to week 24.

  24 Weeks

• Change in total body weight from baseline

  Percent change in total body weight (TBW) from baseline (week 0) to week 24 in body weight.

  24 Weeks

Secondary Outcomes (11)

• Change in total Body Mass Index (BMI) from baseline

  24 Weeks

• Percent change in body composition from baseline

  24 weeks

• Change in waist circumference from baseline

  24 weeks

• Change in insulin sensitivity from baseline

  24 Weeks

• Change in fasting blood lipids from baseline

  24 Weeks

Study Arms (2)

Metformin Extended Release (ER) Oral Tablets

EXPERIMENTAL

This is a 24-week, randomized, double-blinded, two arm parallel clinical trial comparing metformin ER vs. placebo in combination with a hypocaloric diet (-500 kcal/day). 150 individuals with obesity and increased waist circumference will be randomized to taking metformin ER with hypocaloric diet or placebo with hypocaloric diet. All patients will receive dietary and exercise counseling with the intent of reducing their average caloric intake by 500 kcal/day.

Drug: Metformin Extended Release (ER) Oral Tablet

Placebo

PLACEBO COMPARATOR

Patients in the placebo arm will be randomized to placebo with hypocaloric diet. All patients will receive dietary and exercise counseling with the intent of reducing their average caloric intake by 500 kcal/day.

Drug: Placebo

Interventions

Metformin Extended Release (ER) Oral Tablet DRUG

Metformin ER will be provided as 1000 mg capsules by Qingdao Baheal Pharmaceutical Co., Ltd. In addition to the active ingredient metformin HCl,each tablet contains the following inactive ingredients: Povidone, Sodium Lauryl Sulfate, Magnesium Stearate, Cellulose Acetate, Polyethylene Glycol (PEG 400, PEG 8000), Triacetin, Hypromellose, Titanium Dioxide, Polysorbate 80, Ferrosoferric Oxide, Shellac.

Metformin Extended Release (ER) Oral Tablets

Placebo DRUG

Matching placebo will be provided as 1000 mg capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Tablets

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Vijiya Surampudi, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized, single-blind, controlled trial. All eligible participants will be randomly assigned to placebo or Metformin.

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 17, 2023
• Study Start: November 22, 2023
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)