Idiopathic Pulmonary FibrosisPhase 3MAVRICNCT07520110
Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis
A Phase 3 study testing Metformin in people with Idiopathic Pulmonary Fibrosis, run by University of Massachusetts, Worcester at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 15 sitesUnited States
- Study dates
- 28 Sep 2026to 15 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Taking metformin within 3 months of randomization
- Allergy or intolerance to metformin
- Use of insulin or insulin secretagogue(s) at randomization
- 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)
Show all 14Show fewer
- 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
- Receipt of an investigational study agent as part of a therapeutic trial within 30 days of the Screening Visit (Visit 0)
- Continuous supplemental oxygen use at rest greater than 2 L/min
- Unable to swallow pills
- 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.
- 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
- Listed for transplant at the time of randomization
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites
University of Michigan
Ann Arbor, Michigan, 48109
Elizabeth Belloli, MD, 734-647-6477, bellolie@umich.edu
Candace Flaherty, cflah@med.umich.edu
University of Colorado Anschutz
Aurora, Colorado, 80045
Joyce Lee, MD, JOYCE.LEE@cuanschutz.edu
Olivia Brohl, 303-724-0640, olivia.brohl@cuanschutz.edu
Massachusetts General Hospital
Boston, Massachusetts, 02114
Sydney Montesi, MD, 617-726-1721, SBMONTESI@PARTNERS.ORG
Caroline Fromson, 617-643-3260, CFROMSON@MGH.HARVARD.EDU
Northwestern University
Chicago, Illinois, 60611
Bradford Bemiss, MD, 312-695-0478, bradford.bemiss@nm.org
Mary Carns, 312-503-1137, m-carns@northwestern.edu
University of Chicago
Chicago, Illinois, 60637
Ayodeji Adegunsoye, MD, 773-834-3500, aadegunsoye@bsd.uchicago.edu
Vanita Patel, 773-702-1012, vpatel4@bsd.uchicago.edu
University of Texas Southwestern
Dallas, Texas, 75390
Chad Newton, MD, 214-645-6493, Chad.Newton@UTSouthwestern.edu
Nighat Sultana, 214-645-6605, nighat.sultana@utsouthwestern.edu
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
Bhavika Kaul, MD, MAS, 713-440-4400 ext. 230225, Bhavika.Kaul@va.gov
Miguel Alexis Covarrubias Gonzalez, 713-363-3668, Miguel.CovarrubiasGonzalez@va.gov
Weill Cornell Medicine
New York, New York, 10016
Anna Podolanczuk, MD, 646-962-2333, ajp9012@med.cornell.edu
Alicia Morris, 646-962-2741, ajm2017@med.cornell.edu
Temple University
Philadelphia, Pennsylvania, 19140
Rachel Criner, MD, Rachel.Criner@tuhs.temple.edu
Sana Debasree, 215-707-7249, Debasree.SanaBoral@tuhs.temple.edu
Mayo Clinic
Rochester, Minnesota, 55905
Andrew Limper, MD, 507-284-4162, Limper.Andrew@mayo.edu
University of Utah
Salt Lake City, Utah, 84108
Mary Beth Scholand, MD, 801-581-5811, mary.beth.scholand@hsc.utah.edu
Lisa Weaver, 801-581-5811, lisa.weaver@hsc.utah.edu
University of Washington
Seattle, Washington, 98195
Ganesh Raghu, MD, 206-598-0440, graghu@uw.edu
JB Ingram, jingra@uw.edu
University of Arizona
Tucson, Arizona, 85724
Sachin Chaudhary, MD, 520-626-8831, sachin@deptofmed.arizona.edu
Lisbeth Haaheim, 520-626-8831, lhaaheim@arizona.edu
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Helen D'Couto, MD, 202-444-8830, helen.t.d'couto@medstar.net
Amen Hamed, 202-444-0895, amen.m.hamed@gunet.georgetown.edu
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
William M Whalen, MD, william.whalen@umassmemorial.org
Rayaan Yunus, 508-856-2858, rayaan.yunus@umassmed.edu
About this study
Official title: Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis (MAVRIC)
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.
Read the detailed description
This is a multi-center, randomized, double-blind, placebo-controlled trial, of metformin or placebo in 400 participants with idiopathic pulmonary fibrosis (IPF) who are at high risk of adverse clinical outcomes based on a proteomic classifier.
Eligible participants will be placed into 2 groups depending on the results of their proteomic signature blood test done at the Screening Visit (Visit 0).
- Eligible participants who have the proteomic signature present will be randomized in a 1:1 fashion to either metformin at Visit 1 (Enrollment/Baseline) and attend follow-up visits at Months 1, 3, 6, 12, 18, 24, and a follow-up phone call at 25 months. Randomization will be stratified by background FDA-approved IPF therapy (yes/no) and DM status (yes/no).
- Eligible participants who are proteomic signature absent will be asked to complete 2 follow-up remote visits at Months 12 and 24.
The metformin starting dose will be 500 mg daily of extended-release formulation or matching placebo. The dose will be increased by 500 mg every 14 days to a total target daily dose of 1500 mg. Participants will be followed for a minimum of 12 months and a maximum of approximately 25 months, depending on the date of randomization.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Metformin, Matching Placebo
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF, metformin
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
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 PlaceboDrug
Matching placebo over 12 to 24 months depending on time of enrollment into the trial.
| Study group | Role | What they receive |
|---|---|---|
| Proteomic Signature Present - Metformin | Experimental | 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. Receives: Drug: Metformin |
| Proteomic Signature Present - Placebo | Placebo comparator | 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. Receives: Drug: Matching Placebo |
| Proteomic Signature Absent | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to death, non-elective hospitalization, or lung transplantation
Clinical composite measure defined as the time from randomization to the first occurrence of any of its three components: all-cause mortality, first unplanned (non-elective) hospitalization, or lung transplantation.
Measured: Baseline (visit 1) to up to 24 months
Secondary outcomes (21)
Time to all-cause mortality
The time from randomization to death from any cause.
Measured: Baseline (visit 1) to up to 24 months
Time to first non-elective hospitalization
The time from randomization to the first unplanned inpatient hospital admission
Measured: Baseline (visit 1) to up to 24 months
Time to lung transplantation
The time from randomization to the date of a participant's lung transplant
Measured: Baseline (visit 1) to up to 24 months
Time to respiratory hospitalization
The time from randomization to the first non-elective respiratory hospitalization. Non-elective respiratory hospitalizations specifically refer to unplanned admissions where the primary cause is a pulmonary condition, as determined by a blinded adjudication committee.
Measured: Baseline (visit 1) to up to 24 months
Change in Forced Vital Capacity (FVC)
The longitudinal change in forced vital capacity (measured in liters) based on spirometry from baseline (visit 1) to 12 months.
Measured: Baseline (visit 1) to 12 months
Change in Forced Vital Capacity (FVC) % Predicted
The longitudinal change in FVC% predicted based on spirometry from baseline (visit 1) to 12 months.
Measured: Baseline (visit 1) to 12 months
Change in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) corrected for hemoglobin.
Units - ml/(min*mmHg)
Measured: Baseline (visit 1) to 12 months.
Change in Six-Minute Walk Distance (6MWD)
The longitudinal change in the maximum distance (in meters) a participant can walk on a flat surface in six minutes.
Measured: Baseline (visit 1) to 12 months
Change in patient reported outcomes scores for the Living with Pulmonary Fibrosis (L-PF) Impacts Questionnaire
The L-PF Impacts module contains 21 items (5-point Likert scale) that assesses the impact of disease on patients with pulmonary fibrosis. The range of the total score is 0-100, with higher scores indicating greater symptom severity.
Measured: Baseline (visit 1) to 12 months
Change in patient reported outcomes scores for the Living with Pulmonary Fibrosis (L-PF) Impacts Questionnaire
The L-PF Impacts module contains 21 items (5-point Likert scale) that assesses the impact of disease on patients with pulmonary fibrosis. The range of the total score is 0-100, with higher scores indicating greater symptom severity.
Measured: Baseline (visit 1) to 24 months
Change in patient reported outcomes scores for the Living with Pulmonary Fibrosis (L-PF) Symptoms Questionnaire
The L-PF Symptoms modules contains contains 23 items (5-point Likert scale) that assesses shortness of breath, cough, and fatigue within the last 24 hours. The range of the total score is 0-100, with higher scores indicating greater symptom severity.
Measured: Baseline (visit 1) to 12 months
Change in patient reported outcomes scores for the Living with Pulmonary Fibrosis (L-PF) Symptoms Questionnaire
The L-PF Symptoms modules contains contains 23 items (5-point Likert scale) that assesses shortness of breath, cough, and fatigue within the last 24 hours. The range of the total score is 0-100, with higher scores indicating greater symptom severity.
Measured: Baseline (visit 1) to 24 months
Change in patient reported outcomes scores for the R-Scale-PF
The R-Scale-PF is a 5-item numerical rating scale (NRS) to allow for rapid assessment of symptoms and health related quality of life (HRQoL). Scores range from 0 to 50, with lower scores indicating a better HRQoL.
Measured: Baseline (visit 1) to 12 months
Change in patient reported outcomes scores for the R-Scale-PF
The R-Scale-PF is a 5-item numerical rating scale (NRS) to allow for rapid assessment of symptoms and health related quality of life (HRQoL). Scores range from 0 to 50, with lower scores indicating a better HRQoL.
Measured: Baseline (visit 1) to 24 months
Change in Fatigue Severity Scale Score
The Fatigue Severity Scale (FSS) is a nine-item questionnaire used to assess the impact of fatigue on an individual's daily life. The FSS is a self-report measure about their level of fatigue on a scale of 1 to 7, with 7 indicating a higher level of fatigue.
Measured: From baseline (visit 1) to 12 months
Change in Fatigue Severity Scale Score
The Fatigue Severity Scale (FSS) is a nine-item questionnaire used to assess the impact of fatigue on an individual's daily life. The FSS is a self-report measure about their level of fatigue on a scale of 1 to 7, with 7 indicating a higher level of fatigue.
Measured: Baseline (visit 1) to 24 months
Rate of non-elective hospitalization
The rate of all non-elective hospitalizations from baseline (visit 1) to 12 months (number of hospitalizations per year).
Measured: Baseline (visit 1) to 12 months
Rate of non-elective hospitalization from baseline to 24 months
The rate of all non-elective hospitalizations from baseline (visit 1) to 24 months (number of hospitalizations per year).
Measured: Baseline (visit 1) to 24 months
Rate of Respiratory Hospitalizations
The rate of all non-elective respiratory hospitalizations from baseline (visit 1) to 12 months (number of hospitalizations per year).
Non-elective respiratory hospitalizations will be defined as any unplanned inpatient hospitalizations for which the primary cause was a pulmonary condition, in the opinion of the blinded adjudicators and based on all available clinical data.
Measured: Baseline (visit 1) to 12 months
Rate of Respiratory Hospitalizations
The rate of all non-elective respiratory hospitalizations from baseline (visit 1) to 24 months (number of hospitalizations per year)
Non-elective respiratory hospitalizations will be defined as any unplanned inpatient hospitalizations for which the primary cause was a pulmonary condition, in the opinion of the blinded adjudicators and based on all available clinical data.
Measured: Baseline (visit 1) to 24 months
Incidence of Major Adverse Cardiac Events (MACE)
The incidence of major adverse cardiac events (MACE), recorded from baseline (visit 1) through the final follow-up visit. MACE will be determined by the site investigator and defined as a composite of acute myocardial infarction, stroke, or death due to a cardiovascular cause.
Measured: Baseline (visit 1) through final follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start28 Sep 2026 (estimated)
- Primary completion15 Mar 2029 (estimated)
- Study completion15 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with a proteomic signature present are randomized into two separate, concurrent groups-one receiving the active drug (metformin) and the other a matching placebo-and remain in their assigned arm for the entire 12-to-24-month duration.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Fernando J Martinez, University of Massachusetts, Worcester
- Investigators
- Fernando Martinez, MD, MS, Principal investigator, UMass Chan Medical SchoolSydney Montesi, MD, Principal investigator, Massachusetts General HospitalBhavika Kaul, MD, MAS, Principal investigator, Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520110
- Sponsor's protocol ID
- STUDY00002828
- Other IDs
- PR241441
- Acronym
- MAVRIC
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will be conducted in accordance with the publication and data sharing policies and regulations from the Department of Defense Research and Development General Terms and Conditions. De-identified samples and data may be shared with other researchers, institutions, and collaborating for-profit companies within and outside of the United States upon approval of the Ancillary Committee. Data from this study may be requested after the completion of the primary endpoint by contacting the Collaborating Studies Coordinating Center (CSCC) at The University of North Carolina at Chapel Hill.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis (MAVRIC)
- ClinicalTrials.gov ID
- NCT07520110
- Acronym / sponsor ID
- MAVRIC / STUDY00002828
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF, metformin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 15 Mar 2029 (estimated)
- Study completion
- 15 Mar 2029 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled trial, of metformin or placebo in 400 participants with idiopathic pulmonary fibrosis (IPF) who are at high risk of adverse clinical outcomes based on a proteomic classifier.
Eligible participants will be placed into 2 groups depending on the results of their proteomic signature blood test done at the Screening Visit (Visit 0).
- Eligible participants who have the proteomic signature present will be randomized in a 1:1 fashion to either metformin at Visit 1 (Enrollment/Baseline) and attend follow-up visits at Months 1, 3, 6, 12, 18, 24, and a follow-up phone call at 25 months. Randomization will be stratified by background FDA-approved IPF therapy (yes/no) and DM status (yes/no).
- Eligible participants who are proteomic signature absent will be asked to complete 2 follow-up remote visits at Months 12 and 24.
The metformin starting dose will be 500 mg daily of extended-release formulation or matching placebo. The dose will be increased by 500 mg every 14 days to a total target daily dose of 1500 mg. Participants will be followed for a minimum of 12 months and a maximum of approximately 25 months, depending on the date of randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants with a proteomic signature present are randomized into two separate, concurrent groups-one receiving the active drug (metformin) and the other a matching placebo-and remain in their assigned arm for the entire 12-to-24-month duration.
| Arm | Type | Receives |
|---|---|---|
| Proteomic Signature Present - Metformin | Experimental | Drug: Metformin200 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. |
| Proteomic Signature Present - Placebo | Placebo comparator | Drug: Matching Placebo200 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. |
| Proteomic Signature Absent | No intervention | –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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- Taking metformin within 3 months of randomization
- Allergy or intolerance to metformin
- Use of insulin or insulin secretagogue(s) at randomization
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin 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 | Proteomic Signature Present - Metformin |
| Matching PlaceboMatching placebo over 12 to 24 months depending on time of enrollment into the trial. | Drug | Proteomic Signature Present - Placebo |
Primary outcome
Time to death, non-elective hospitalization, or lung transplantation
Time frame: Baseline (visit 1) to up to 24 months
Clinical composite measure defined as the time from randomization to the first occurrence of any of its three components: all-cause mortality, first unplanned (non-elective) hospitalization, or lung transplantation.
21 secondary outcomes
Time to all-cause mortality
Time frame: Baseline (visit 1) to up to 24 months
Time to first non-elective hospitalization
Time frame: Baseline (visit 1) to up to 24 months
Time to lung transplantation
Time frame: Baseline (visit 1) to up to 24 months
Time to respiratory hospitalization
Time frame: Baseline (visit 1) to up to 24 months
Change in Forced Vital Capacity (FVC)
Time frame: Baseline (visit 1) to 12 months
Change in Forced Vital Capacity (FVC) % Predicted
Time frame: Baseline (visit 1) to 12 months
Change in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) corrected for hemoglobin.
Time frame: Baseline (visit 1) to 12 months.
Change in Six-Minute Walk Distance (6MWD)
Time frame: Baseline (visit 1) to 12 months
Change in patient reported outcomes scores for the Living with Pulmonary Fibrosis (L-PF) Impacts Questionnaire
Time frame: Baseline (visit 1) to 12 months
Change in patient reported outcomes scores for the Living with Pulmonary Fibrosis (L-PF) Impacts Questionnaire
Time frame: Baseline (visit 1) to 24 months
Change in patient reported outcomes scores for the Living with Pulmonary Fibrosis (L-PF) Symptoms Questionnaire
Time frame: Baseline (visit 1) to 12 months
Change in patient reported outcomes scores for the Living with Pulmonary Fibrosis (L-PF) Symptoms Questionnaire
Time frame: Baseline (visit 1) to 24 months
Change in patient reported outcomes scores for the R-Scale-PF
Time frame: Baseline (visit 1) to 12 months
Change in patient reported outcomes scores for the R-Scale-PF
Time frame: Baseline (visit 1) to 24 months
Change in Fatigue Severity Scale Score
Time frame: From baseline (visit 1) to 12 months
Change in Fatigue Severity Scale Score
Time frame: Baseline (visit 1) to 24 months
Rate of non-elective hospitalization
Time frame: Baseline (visit 1) to 12 months
Rate of non-elective hospitalization from baseline to 24 months
Time frame: Baseline (visit 1) to 24 months
Rate of Respiratory Hospitalizations
Time frame: Baseline (visit 1) to 12 months
Rate of Respiratory Hospitalizations
Time frame: Baseline (visit 1) to 24 months
Incidence of Major Adverse Cardiac Events (MACE)
Time frame: Baseline (visit 1) through final follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. This study will be conducted in accordance with the publication and data sharing policies and regulations from the Department of Defense Research and Development General Terms and Conditions. De-identified samples and data may be shared with other researchers, institutions, and collaborating for-profit companies within and outside of the United States upon approval of the Ancillary Committee. Data from this study may be requested after the completion of the primary endpoint by contacting the Collaborating Studies Coordinating Center (CSCC) at The University of North Carolina at Chapel Hill.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando Martinez, MD, MS principal investigator
UMass Chan Medical School
Sydney Montesi, MD principal investigator
Massachusetts General Hospital
Bhavika Kaul, MD, MAS principal investigator
Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC)
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin in people with Idiopathic Pulmonary Fibrosis, run by University of Massachusetts, Worcester at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to death, non-elective hospitalization, or lung transplantation (time frame: Baseline (visit 1) to up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.