[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07520110":3,"trial-entities:NCT07520110":370,"trial-summary:NCT07520110":374},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":47,"sex":107,"minimum_age":108,"maximum_age":109,"healthy_volunteers":110,"eligibility_criteria":111,"std_ages":115,"locations":118,"central_contacts":359,"overall_officials":360,"references":368,"see_also_links":369},"NCT07520110","STUDY00002828","Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis","Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis (MAVRIC)","NOT_YET_RECRUITING","2029-03-15","2026-09","2026-09-08","2026-09-28","University of Massachusetts, Worcester","OTHER",true,"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.\n\nApproximately 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.","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.\n\nEligible participants will be placed into 2 groups depending on the results of their proteomic signature blood test done at the Screening Visit (Visit 0).\n\n* Eligible participants who have the proteomic signature present will be randomized in a 1:1 fashion to either metformin at Visit 1 (Enrollment\u002FBaseline) 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\u002Fno) and DM status (yes\u002Fno).\n* Eligible participants who are proteomic signature absent will be asked to complete 2 follow-up remote visits at Months 12 and 24.\n\nThe 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.",[19],"Idiopathic Pulmonary Fibrosis",[19,21,22],"IPF","metformin","INTERVENTIONAL","TREATMENT",[26],"PHASE3",{"count":28,"type":29},800,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"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.",[36],"Proteomic Signature Present - Metformin",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Matching Placebo","Matching placebo over 12 to 24 months depending on time of enrollment into the trial.",[41],"Proteomic Signature Present - Placebo",[43],{"measure":44,"description":45,"timeFrame":46},"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.","Baseline (visit 1) to up to 24 months",[48,51,54,57,60,64,67,71,74,77,79,82,83,86,87,91,92,95,98,101,103],{"measure":49,"description":50,"timeFrame":46},"Time to all-cause mortality","The time from randomization to death from any cause.",{"measure":52,"description":53,"timeFrame":46},"Time to first non-elective hospitalization","The time from randomization to the first unplanned inpatient hospital admission",{"measure":55,"description":56,"timeFrame":46},"Time to lung transplantation","The time from randomization to the date of a participant's lung transplant",{"measure":58,"description":59,"timeFrame":46},"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.",{"measure":61,"description":62,"timeFrame":63},"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.","Baseline (visit 1) to 12 months",{"measure":65,"description":66,"timeFrame":63},"Change in Forced Vital Capacity (FVC) % Predicted","The longitudinal change in FVC% predicted based on spirometry from baseline (visit 1) to 12 months.",{"measure":68,"description":69,"timeFrame":70},"Change in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) corrected for hemoglobin.","Units - ml\u002F(min\\*mmHg)","Baseline (visit 1) to 12 months.",{"measure":72,"description":73,"timeFrame":63},"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.",{"measure":75,"description":76,"timeFrame":63},"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.",{"measure":75,"description":76,"timeFrame":78},"Baseline (visit 1) to 24 months",{"measure":80,"description":81,"timeFrame":63},"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.",{"measure":80,"description":81,"timeFrame":78},{"measure":84,"description":85,"timeFrame":63},"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.",{"measure":84,"description":85,"timeFrame":78},{"measure":88,"description":89,"timeFrame":90},"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.","From baseline (visit 1) to 12 months",{"measure":88,"description":89,"timeFrame":78},{"measure":93,"description":94,"timeFrame":63},"Rate of non-elective hospitalization","The rate of all non-elective hospitalizations from baseline (visit 1) to 12 months (number of hospitalizations per year).",{"measure":96,"description":97,"timeFrame":78},"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).",{"measure":99,"description":100,"timeFrame":63},"Rate of Respiratory Hospitalizations","The rate of all non-elective respiratory hospitalizations from baseline (visit 1) to 12 months (number of hospitalizations per year).\n\nNon-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.",{"measure":99,"description":102,"timeFrame":78},"The rate of all non-elective respiratory hospitalizations from baseline (visit 1) to 24 months (number of hospitalizations per year)\n\nNon-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.",{"measure":104,"description":105,"timeFrame":106},"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.","Baseline (visit 1) through final follow-up visit","ALL","40 Years",null,false,{"inclusion":112,"exclusion":113,"raw_text":114},[],[],"Inclusion Criteria:\n\n1. IPF diagnosis by enrolling investigator (following the 2022 updated guidelines on diagnosis and management of IPF)\n2. Age 40 years or older\n3. HbA1c \\\u003C 9% at screening\n4. 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).\n5. If on FDA-approved treatment(s) for IPF, on a stable dose for at least 8 weeks prior to randomization\n6. Ability to provide informed consent\n\nExclusion Criteria:\n\n1. Taking metformin within 3 months of randomization\n2. Allergy or intolerance to metformin\n3. Use of insulin or insulin secretagogue(s) at randomization\n4. Pregnancy, planning to become pregnant, or lactating\n5. 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 \\\u003C1% per year during study participation\n6. History of biochemically-confirmed acidosis (lactate \\> 5.0 mmol\u002FL)\n7. Estimated glomerular filtration rate less than 45 mL\u002Fmin\u002F1.73 m2 at screening\n8. 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\n9. Receipt of an investigational study agent as part of a therapeutic trial within 30 days of the Screening Visit (Visit 0)\n10. Continuous supplemental oxygen use at rest greater than 2 L\u002Fmin\n11. Unable to swallow pills\n12. 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.\n13. 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\n14. Listed for transplant at the time of randomization",[116,117],"ADULT","OLDER_ADULT",[119,137,153,170,187,200,217,232,248,261,277,293,310,327,343],{"facility":120,"city":121,"state":122,"zip":123,"country":124,"contacts":125,"geoPoint":134},"University of Arizona","Tucson","Arizona","85724","United States",[126,131],{"name":127,"role":128,"phone":129,"email":130},"Sachin Chaudhary, MD","CONTACT","520-626-8831","sachin@deptofmed.arizona.edu",{"name":132,"role":128,"phone":129,"email":133},"Lisbeth Haaheim","lhaaheim@arizona.edu",{"lat":135,"lon":136},32.22174,-110.92648,{"facility":138,"city":139,"state":140,"zip":141,"country":124,"contacts":142,"geoPoint":150},"University of Colorado Anschutz","Aurora","Colorado","80045",[143,146],{"name":144,"role":128,"email":145},"Joyce Lee, MD","JOYCE.LEE@cuanschutz.edu",{"name":147,"role":128,"phone":148,"email":149},"Olivia Brohl","303-724-0640","olivia.brohl@cuanschutz.edu",{"lat":151,"lon":152},39.72943,-104.83192,{"facility":154,"city":155,"state":156,"zip":157,"country":124,"contacts":158,"geoPoint":167},"Georgetown University Hospital","Washington D.C.","District of Columbia","20007",[159,163],{"name":160,"role":128,"phone":161,"email":162},"Helen D'Couto, MD","202-444-8830","helen.t.d'couto@medstar.net",{"name":164,"role":128,"phone":165,"email":166},"Amen Hamed","202-444-0895","amen.m.hamed@gunet.georgetown.edu",{"lat":168,"lon":169},38.89511,-77.03637,{"facility":171,"city":172,"state":173,"zip":174,"country":124,"contacts":175,"geoPoint":184},"Northwestern University","Chicago","Illinois","60611",[176,180],{"name":177,"role":128,"phone":178,"email":179},"Bradford Bemiss, MD","312-695-0478","bradford.bemiss@nm.org",{"name":181,"role":128,"phone":182,"email":183},"Mary Carns","312-503-1137","m-carns@northwestern.edu",{"lat":185,"lon":186},41.85003,-87.65005,{"facility":188,"city":172,"state":173,"zip":189,"country":124,"contacts":190,"geoPoint":199},"University of Chicago","60637",[191,195],{"name":192,"role":128,"phone":193,"email":194},"Ayodeji Adegunsoye, MD","773-834-3500","aadegunsoye@bsd.uchicago.edu",{"name":196,"role":128,"phone":197,"email":198},"Vanita Patel","773-702-1012","vpatel4@bsd.uchicago.edu",{"lat":185,"lon":186},{"facility":201,"city":202,"state":203,"zip":204,"country":124,"contacts":205,"geoPoint":214},"Massachusetts General Hospital","Boston","Massachusetts","02114",[206,210],{"name":207,"role":128,"phone":208,"email":209},"Sydney Montesi, MD","617-726-1721","SBMONTESI@PARTNERS.ORG",{"name":211,"role":128,"phone":212,"email":213},"Caroline Fromson","617-643-3260","CFROMSON@MGH.HARVARD.EDU",{"lat":215,"lon":216},42.35843,-71.05977,{"facility":218,"city":219,"state":203,"zip":220,"country":124,"contacts":221,"geoPoint":229},"University of Massachusetts Chan Medical School","Worcester","01655",[222,225],{"name":223,"role":128,"email":224},"William M Whalen, MD","william.whalen@umassmemorial.org",{"name":226,"role":128,"phone":227,"email":228},"Rayaan Yunus","508-856-2858","rayaan.yunus@umassmed.edu",{"lat":230,"lon":231},42.26259,-71.80229,{"facility":233,"city":234,"state":235,"zip":236,"country":124,"contacts":237,"geoPoint":245},"University of Michigan","Ann Arbor","Michigan","48109",[238,242],{"name":239,"role":128,"phone":240,"email":241},"Elizabeth Belloli, MD","734-647-6477","bellolie@umich.edu",{"name":243,"role":128,"email":244},"Candace Flaherty","cflah@med.umich.edu",{"lat":246,"lon":247},42.27756,-83.74088,{"facility":249,"city":250,"state":251,"zip":252,"country":124,"contacts":253,"geoPoint":258},"Mayo Clinic","Rochester","Minnesota","55905",[254],{"name":255,"role":128,"phone":256,"email":257},"Andrew Limper, MD","507-284-4162","Limper.Andrew@mayo.edu",{"lat":259,"lon":260},44.02163,-92.4699,{"facility":262,"city":263,"state":263,"zip":264,"country":124,"contacts":265,"geoPoint":274},"Weill Cornell Medicine","New York","10016",[266,270],{"name":267,"role":128,"phone":268,"email":269},"Anna Podolanczuk, MD","646-962-2333","ajp9012@med.cornell.edu",{"name":271,"role":128,"phone":272,"email":273},"Alicia Morris","646-962-2741","ajm2017@med.cornell.edu",{"lat":275,"lon":276},40.71427,-74.00597,{"facility":278,"city":279,"state":280,"zip":281,"country":124,"contacts":282,"geoPoint":290},"Temple University","Philadelphia","Pennsylvania","19140",[283,286],{"name":284,"role":128,"email":285},"Rachel Criner, MD","Rachel.Criner@tuhs.temple.edu",{"name":287,"role":128,"phone":288,"email":289},"Sana Debasree","215-707-7249","Debasree.SanaBoral@tuhs.temple.edu",{"lat":291,"lon":292},39.95238,-75.16362,{"facility":294,"city":295,"state":296,"zip":297,"country":124,"contacts":298,"geoPoint":307},"University of Texas Southwestern","Dallas","Texas","75390",[299,303],{"name":300,"role":128,"phone":301,"email":302},"Chad Newton, MD","214-645-6493","Chad.Newton@UTSouthwestern.edu",{"name":304,"role":128,"phone":305,"email":306},"Nighat Sultana","214-645-6605","nighat.sultana@utsouthwestern.edu",{"lat":308,"lon":309},32.78306,-96.80667,{"facility":311,"city":312,"state":296,"zip":313,"country":124,"contacts":314,"geoPoint":324},"Michael E. DeBakey VA Medical Center","Houston","77030",[315,320],{"name":316,"role":128,"phone":317,"phoneExt":318,"email":319},"Bhavika Kaul, MD, MAS","713-440-4400","230225","Bhavika.Kaul@va.gov",{"name":321,"role":128,"phone":322,"email":323},"Miguel Alexis Covarrubias Gonzalez","713-363-3668","Miguel.CovarrubiasGonzalez@va.gov",{"lat":325,"lon":326},29.76328,-95.36327,{"facility":328,"city":329,"state":330,"zip":331,"country":124,"contacts":332,"geoPoint":340},"University of Utah","Salt Lake City","Utah","84108",[333,337],{"name":334,"role":128,"phone":335,"email":336},"Mary Beth Scholand, MD","801-581-5811","mary.beth.scholand@hsc.utah.edu",{"name":338,"role":128,"phone":335,"email":339},"Lisa Weaver","lisa.weaver@hsc.utah.edu",{"lat":341,"lon":342},40.76078,-111.89105,{"facility":344,"city":345,"state":346,"zip":347,"country":124,"contacts":348,"geoPoint":356},"University of Washington","Seattle","Washington","98195",[349,353],{"name":350,"role":128,"phone":351,"email":352},"Ganesh Raghu, MD","206-598-0440","graghu@uw.edu",{"name":354,"role":128,"email":355},"JB Ingram","jingra@uw.edu",{"lat":357,"lon":358},47.60621,-122.33207,[],[361,365,366],{"name":362,"affiliation":363,"role":364},"Fernando Martinez, MD, MS","UMass Chan Medical School","PRINCIPAL_INVESTIGATOR",{"name":207,"affiliation":201,"role":364},{"name":316,"affiliation":367,"role":364},"Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC)",[],[],{"nct_id":4,"conditions":371,"biomarkers":372},[19],[373],"proteomic signature",{"nct_id":4,"found":15,"summary":375,"prompt_version":385},{"design":376,"status":377,"heading":378,"summary":379,"follow_up":380,"word_count":381,"commitments":382,"compensation":383,"drugs_mentioned":384},"This is a randomized, double-blind study comparing metformin to a placebo in 400 participants with IPF who are at high risk based on a proteomic signature.","completed","Metformin for Idiopathic Pulmonary Fibrosis","This study is testing if metformin can help slow down the worsening of Idiopathic Pulmonary Fibrosis (IPF), a serious lung disease. Researchers are looking for 800 people with IPF, aged 40 or older, who have a specific \"proteomic signature\" (a pattern found in blood tests) that suggests they are at high risk for their disease getting worse. If you qualify, you would either receive metformin or a matching placebo (an inactive substance) for 12 to 24 months. The main goal is to see if metformin can reduce the risk of death, unplanned hospital stays, or needing a lung transplant. The study's current status is unclear.","Participants will be followed for a minimum of 12 months and a maximum of approximately 25 months after starting treatment.",105,"If you have the proteomic signature, you would take metformin or placebo daily, with the dose gradually increasing. You would have follow-up visits at months 1, 3, 6, 12, 18, 24, and a phone call at 25 months.","Not stated in the trial record.",[33,38],"v2"]