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Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis

NCT07520110 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Fernando Martinez, MD, MS · UMass Chan Medical School

  • Sydney Montesi, MD · Massachusetts General Hospital

  • Bhavika Kaul, MD, MAS · Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-03-15
Completion
2029-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07520110 on ClinicalTrials.gov