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Could a common diabetes drug help fight a deadly lung disease?

NCT ID NCT07520110

Disease control Sponsor: University of Massachusetts, Worcester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This study tests whether metformin, a standard diabetes medicine, can slow the worsening of idiopathic pulmonary fibrosis (IPF), a serious lung disease. About 400 high-risk patients will receive either metformin or a placebo. The goal is to see if metformin can delay death, hospital stays, or the need for a lung transplant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. IPF diagnosis by enrolling investigator (following the 2022 updated guidelines on diagnosis and management of IPF) 2. Age 40 years or older 3. HbA1c \< 9% at screening 4. 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). 5. If on FDA-approved treatment(s) for IPF, on a stable dose for at least 8 weeks prior to randomization 6. Ability to provide informed consent Exclusion Criteria: 1. Taking metformin within 3 months of randomization 2. Allergy or intolerance to metformin 3. Use of insulin or insulin secretagogue(s) at randomization 4. Pregnancy, planning to become pregnant, or lactating 5. 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 6. History of biochemically-confirmed acidosis (lactate \> 5.0 mmol/L) 7. Estimated glomerular filtration rate less than 45 mL/min/1.73 m2 at screening 8. 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 9. Receipt of an investigational study agent as part of a therapeutic trial within 30 days of the Screening Visit (Visit 0) 10. Continuous supplemental oxygen use at rest greater than 2 L/min 11. Unable to swallow pills 12. Taking a medication that has a major interaction with metformin, including acetazolamide (Diamox), cimetidine (Tagamet), dolutegravir, gatifloxacin, levoketoconazole, ranolazine, or carbonic anhydrase inhibitors. Occasional use of carbonic anhydrase inhibitors for travel is permitted. 13. Current alcohol intake ≥ 15 drinks per week in men, ≥ 8 drinks per week in women or ≥ 5 drinks per occasion in men, ≥ 4 drinks per occasion in women 14. Listed for transplant at the time of randomization

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Michael E. DeBakey VA Medical Center

    Houston, Texas, 77030, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • University of Arizona

    Tucson, Arizona, 85724, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Colorado Anschutz

    Aurora, Colorado, 80045, United States

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Weill Cornell Medicine

    New York, New York, 10016, United States

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