Metformin for Idiopathic Pulmonary Fibrosis

(MAVRIC Trial)

Not yet recruiting at 14 trial locations
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether metformin can safely and effectively aid individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that impairs breathing. It targets those at high risk of severe outcomes, identified by a specific blood test result. Participants will take either metformin or a placebo (a pill with no active drug) for up to two years. Those with a long history of IPF and frequent breathing problems might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

You may need to stop taking certain medications that interact with metformin, such as acetazolamide, cimetidine, and others listed in the trial's exclusion criteria. If you are on FDA-approved treatments for IPF, you must be on a stable dose for at least 8 weeks before joining the trial.

Is there any evidence suggesting that metformin is likely to be safe for humans?

Research has shown that metformin, a common diabetes drug, has been tested for safety in people with idiopathic pulmonary fibrosis (IPF). Studies have found that patients generally tolerate metformin well. In one study, participants taking metformin had a lower risk of dying from any cause. However, some research suggests that metformin users might experience a worsening of their condition over time.

Metformin is already FDA-approved for diabetes, indicating its safety for that use. However, for IPF, more research is needed to confirm its safety and effectiveness. While metformin appears safe, its full effects on IPF remain under investigation.12345

Why do researchers think this study treatment might be promising for IPF?

Unlike the standard treatments for idiopathic pulmonary fibrosis, which typically focus on slowing disease progression with drugs like pirfenidone and nintedanib, metformin offers a novel approach by potentially targeting underlying metabolic pathways. Researchers are excited about metformin because it has a different mechanism of action, primarily known for regulating glucose levels in diabetes, which may also influence lung tissue remodeling. This could open up new possibilities for managing the condition and provide additional benefits not addressed by current therapies.

What evidence suggests that metformin might be an effective treatment for idiopathic pulmonary fibrosis?

Research suggests that metformin, a common diabetes medication, might benefit people with idiopathic pulmonary fibrosis (IPF), a lung disease. Some studies have shown that it could improve health outcomes for patients with type 2 diabetes. Metformin may reduce lung scarring and aid in lung cell healing. However, not all research agrees, and some studies have not found a significant benefit. In this trial, participants with a specific proteomic signature will receive either metformin or a placebo to further investigate its effects on IPF. It is important to remember that the effects of metformin on IPF are still under study, and more research is needed.23567

Who Is on the Research Team?

FM

Fernando Martinez, MD, MS

Principal Investigator

UMass Chan Medical School

SM

Sydney Montesi, MD

Principal Investigator

Massachusetts General Hospital

BK

Bhavika Kaul, MD, MAS

Principal Investigator

Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC)

Are You a Good Fit for This Trial?

This trial is for adults aged 40 or older with idiopathic pulmonary fibrosis (IPF) who are at high risk of poor outcomes based on a blood test. Participants must have stable IPF treatment, good kidney and liver function, not be pregnant or breastfeeding, and cannot use insulin or certain other medications.

Inclusion Criteria

HbA1c < 9% at screening
I am 40 years old or older.
Ability to provide informed consent
See 3 more

Exclusion Criteria

I do not have serious liver disease, severe heart failure, or other major health issues.
I am currently using insulin or medicines that help my body release insulin.
Pregnancy, planning to become pregnant, or lactating
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive metformin or placebo, with dose adjustments every 14 days, followed by regular follow-up visits

12 to 24 months
Visits at Months 1, 3, 6, 12, 18, 24, and a follow-up phone call at 25 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month
1 follow-up phone call

Remote Follow-up for Proteomic Signature Absent

Participants without the proteomic signature are contacted to review medical history

24 months
2 remote visits at Months 12 and 24

What Are the Treatments Tested in This Trial?

Interventions

  • Metformin

Trial Overview

The study compares metformin to a placebo in about 400 people with high-risk IPF. Participants are randomly assigned to receive either metformin or an inactive pill to see if metformin can slow down lung decline safely.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Proteomic Signature Present - MetforminExperimental Treatment1 Intervention
Group II: Proteomic Signature AbsentActive Control1 Intervention
Group III: Proteomic Signature Present - PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials
372
Recruited
998,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Citations

Metformin Improves Outcomes in IPF Real-World Study

Metformin may improve clinical outcomes in patients with idiopathic pulmonary fibrosis (IPF) and type 2 diabetes mellitus.

Evaluation for clinical benefit of metformin in patients ... - PMC

Among patients with IPF and T2DM, metformin therapy may be associated with improved clinical outcomes. However, further investigation with randomized clinical ...

Combination Metformin and Low-Dose Nintedanib ...

Metformin was effective in reducing pulmonary fibrosis in human IPF fibroblasts and when used in combination with low-dose nintedanib, ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35410255/

Evaluation for clinical benefit of metformin in patients with ...

Conclusions: Among patients with IPF and T2DM, metformin therapy may be associated with improved clinical outcomes. However, further ...

Effect of metformin on clinically relevant outcomes in patients ...

Conclusions: In this post-hoc analysis, metformin did not show any effect on clinically relevant outcomes in patients with IPF.

Association of metformin with lung function decline and ... - PMC

In our study, metformin did not significantly alter lung function decline in fibrotic ILD despite laboratory evidence of antifibrotic properties. Keywords: ...

Metformin to Attenuate Progressive Respiratory Decline in ...

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 ...