Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT07520110
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    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.
  • Matching Placebo — DRUG
    Matching placebo over 12 to 24 months depending on time of enrollment into the trial.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
Apr 2026
Primary completion
Mar 15, 2029
Completion
Mar 15, 2029

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Proteomic Signature Present - Metformin
    200 participants who have a screening blood test result that is proteomic signature present will be randomized to oral metformin at a total target daily dose of 1500mg per day for 12 to 24 months depending on time of enrollment into the trial.
  • Placebo Comparator: Proteomic Signature Present - Placebo
    200 participants who have a screening blood test result that is proteomic signature present will be randomized to matching placebo 12 to 24 months depending on time of enrollment into the trial.
  • No Intervention: Proteomic Signature Absent
    Participants that meet the eligibility criteria but do have a screening blood test result that is proteomic signature absent (about 400 participants) will be asked to attend 2 follow-up remote visits at 12 and 24 months. This arm will be observational only.

Primary Outcome Measure

Time to death, non-elective hospitalization, or lung transplantation [ Time Frame: Baseline (visit 1) to up to 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Massachusetts Chan Medical SchoolWorcesterMassachusetts01655
William M Whalen, MD
[email protected]
Rayaan Yunus
[email protected]
508-856-2858

Find similar trials in Worcester, MA

By research site
University of Massachusetts Chan Medical School· Worcester, MA

Related Studies