Metformin for Obesity

Phase 4

Recruiting

Led By Vijiya Surampudi, MD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial aims to see if metformin, combined with a low-calorie diet, helps reduce weight and improve quality of life in obese/overweight adults.

Who is the study for?

Adults over 18 with obesity, specifically those with a waist size over 40 inches for men and over 35 inches for women, and a BMI of at least 27. Participants must not have had recent severe health events like heart attacks or strokes, any unstable conditions, allergies to metformin, poorly controlled diabetes (HbA1c >7.5), significant kidney issues (eGFR <45 mL/min/1.73 m2), thyroid disease without stable treatment for the past six months, weight changes greater than 11 pounds in the last three months, certain diabetes medications use including insulin or oral metformin, history of lactic acidosis or liver problems.

What is being tested?

The trial is testing Metformin Extended Release tablets against placebo pills to see if they help reduce waist circumference when combined with a low-calorie diet in overweight adults. It also examines how Metformin affects quality of life and physical activity levels compared to the placebo.

What are the potential side effects?

Metformin can cause digestive issues such as stomach pain, diarrhea; it may also lead to vitamin B12 deficiency long-term. Rarely it could cause a serious condition called lactic acidosis where too much acid builds up in the blood.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in total body weight from baseline

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

Secondary study objectives

Change in fasting blood lipids from baseline

Change in insulin sensitivity from baseline

Change in total Body Mass Index (BMI) from baseline

+2 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Metformin Extended Release (ER) Oral TabletsExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out