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NOT YET RECRUITING
NCT07520110
PHASE3

Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis

Sponsor: University of Massachusetts, Worcester

View on ClinicalTrials.gov

Summary

This is a randomized, placebo-controlled trial of metformin in 400 participants with idiopathic pulmonary fibrosis (IPF) who are at high risk of adverse clinical outcomes based on a proteomic classifier. The primary objective is to assess the safety and efficacy of metformin compared to placebo in participants with IPF who are at high-risk for adverse clinical events. Approximately 800 participants with IPF will be screened. 400 participants who are at high risk for adverse clinical events (proteomic signature present) will be randomized into receiving metformin (n\~200) or matching placebo (n\~200). Participants that meet the eligibility criteria but do not have the proteomic signature (proteomic signature absent) will be contacted by phone at 12 and 24 months to review medical history.

Official title: Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis (MAVRIC)

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2026-09-28

Completion Date

2029-03-15

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

DRUG

Metformin

Metformin or matching placebo over 12 to 24 months depending on time of enrollment into the trial. The dose will be increased by 500 mg every 14 days to a total target daily dose of 1500 mg.

DRUG

Matching Placebo

Matching placebo over 12 to 24 months depending on time of enrollment into the trial.

Locations (15)

University of Arizona

Tucson, Arizona, United States

University of Colorado Anschutz

Aurora, Colorado, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Weill Cornell Medicine

New York, New York, United States

Temple University

Philadelphia, Pennsylvania, United States

University of Texas Southwestern

Dallas, Texas, United States

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Washington

Seattle, Washington, United States