Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis (NCT07520110) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis
United States800 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. 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).
✓. If on FDA-approved treatment(s) for IPF, on a stable dose for at least 8 weeks prior to randomization
✓. Ability to provide informed consent
Exclusion criteria
✕. Taking metformin within 3 months of randomization
✕. Allergy or intolerance to metformin
✕. Use of insulin or insulin secretagogue(s) at randomization
✕
What they're measuring
1
Time to death, non-elective hospitalization, or lung transplantation
. Pregnancy, planning to become pregnant, or lactating
✕. Women of childbearing potential not willing to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of \<1% per year during study participation
✕. History of biochemically-confirmed acidosis (lactate \> 5.0 mmol/L)
✕. Estimated glomerular filtration rate less than 45 mL/min/1.73 m2 at screening
✕. Moderate-to-severe liver disease, decompensated heart failure, or any other condition that may make the participant unsuitable for inclusion as assessed by the study investigator at each site