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
Parallel
Metformin
DrugMetformin 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.
Matching Placebo
DrugMatching placebo over 12 to 24 months depending on time of enrollment into the trial.
Time to death, non-elective hospitalization, or lung transplantation
Clinical composite measure defined as the time from randomization to the first occurrence of any of its three components: all-cause mortality, first unplanned (non-elective) hospitalization, or lung transplantation.
Time to all-cause mortality
The time from randomization to death from any cause.
Time to first non-elective hospitalization
The time from randomization to the first unplanned inpatient hospital admission
Time to lung transplantation
The time from randomization to the date of a participant's lung transplant
Time to respiratory hospitalization
The time from randomization to the first non-elective respiratory hospitalization. Non-elective respiratory hospitalizations specifically refer to unplanned admissions where the primary cause is a pulmonary condition, as determined by a blinded adjudication committee.
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University of Massachusetts, Worcester
Lead sponsor
United States Department of Defense
Collaborator
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