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.
IPF diagnosis by enrolling investigator (following the 2022 updated guidelines on diagnosis and management of IPF)
Age 40 years or older
HbA1c < 9% at screening
High risk by proteomic signature (proteomic signature present) for participants randomized only (for participants randomized only; participants that are proteomic signature absent will undergo remote study assessments at 12 and 24 months only).
Taking metformin within 3 months of randomization
Allergy or intolerance to metformin
Use of insulin or insulin secretagogue(s) at randomization
Pregnancy, planning to become pregnant, or lactating
University of Massachusetts, Worcester
Lead sponsor
United States Department of Defense
Collaborator