New pill aims to slow lung scarring in IPF patients
NCT ID NCT07284459
First seen Jun 26, 2026 · Last updated Sep 21, 2026 · Updated 29 times
Summary
This phase 2 trial tests an oral drug called PIPE-791 in 324 adults with idiopathic pulmonary fibrosis (IPF), a disease that scars the lungs and makes breathing hard. Participants take either a low or high dose of PIPE-791 or a placebo daily for several months. The main goal is to see if the drug can slow the decline in lung function measured by forced vital capacity (FVC).
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PIPE-791 (oral tablet)
- What this could lead to
- If it works, this could point toward a new daily treatment to slow lung damage and help people with IPF breathe easier.
- What could go wrong
- This is a mid-stage trial with 324 people, so results are not final. The drug may not improve lung function or could cause side effects.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 324 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Key Inclusion Criteria: * Male or female ≥ 40 years of age at the time of Randomization. * A diagnosis of IPF within 7 years prior to Screening, based on the 2022 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT consistent with usual interstitial pneumonia (UIP) or probable UIP. * Percent predicted (pp) FVC ≥ 40% on Screening spirometry. * Participants may enter the study whether or not they are receiving background nintedanib or pirfenidone therapy approved for the treatment of IPF, but not both concurrently. Key Exclusion Criteria: * Those with a history of interstitial lung disease (ILD) other than IPF are not eligible. * Those with pulmonary arterial hypertension (PAH) requiring multi-drug therapy are not eligible. * Those who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, are not eligible. * Those with an estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) (Inker 2021) or who have Child-Pugh Class B or C hepatic impairment are not eligible. * Female participants must not be of childbearing potential. Additional inclusion and exclusion criteria apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
72 sites in 11 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS
RECRUITINGPapatoetoe, Auckland, 2025, New Zealand
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Asan Medical Center
RECRUITINGSongpa-dong, Seoul, 05505, South Korea
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Assuta Ashdod University Medical Center
RECRUITINGAshdod, Southern District, 7747629, Israel
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Austin Health
RECRUITINGHeidelberg, Victoria, 3084, Australia
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Biocinetic Servicios Medicos Ltda
RECRUITINGSantiago, Santiago Metropolitan, 8320000, Chile
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Birmingham Heartlands Hospital
RECRUITINGBirmingham, B3 3HX, United Kingdom
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CEC SpA
RECRUITINGÑuñoa, Santiago Metropolitan, 7750495, Chile
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CIMER-Centro Integral de Medicina Respiratoria
RECRUITINGSan Miguel de Tucumán, Tucumán Province, T4000CBC, Argentina
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CINME S.A. - Centro de Investigaciones Metabólicas - Viamonte 2213/2215
RECRUITINGBuenos Aires, Buenos Aires F.D., C1056ABI, Argentina
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Canterbury Respiratory Research Group
RECRUITINGChristchurch, Canterbury, 8001, New Zealand
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Centre Hospitalier de l'Universite de Montreal
RECRUITINGMontreal, Quebec, H2X 0A9, Canada
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Centre d'investigation Clinique Mauricie
RECRUITINGTrois-Rivières, Quebec City, G8T 7A1, Canada
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Centro Modelo de Cardiología-Laprida 554
RECRUITINGSan Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina
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Centro Médico Dra de Salvo - Fundacion Respirar - PPDS
RECRUITINGBuenos Aires, C1426ABP, Argentina
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Centro Respiratorio Quilmes
RECRUITINGQuilmes, Buenos Aires, B1878FNR, Argentina
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Centro de Diagnóstico Y Rehabilitación - Santa Fe - San Luis
RECRUITINGSan Luis, Santa Fe Province, S3000GBL, Argentina
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Centro de Investigacion Curicó
RECRUITINGCuricó, Maule Region, 3341643, Chile
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Centro de Investigacion de Enfermedades Respiratorias e Inmunologicas
RECRUITINGViña del Mar, Valparaiso, 2520000, Chile
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Centro de Investigaciones Clinicas Vina del Mar
RECRUITINGViña del Mar, Valparaiso, 2520000, Chile
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Centro de Investigaciones Médicas Tucumán - PPDS
RECRUITINGSan Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
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Clinica Internacional - PPDS
RECRUITINGLima, Lima Province, 15001, Peru
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Consultorios Médicos Organización del Buen Ayre SRL
RECRUITINGBuenos Aires, C1425FVH, Argentina
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Dr. Anil Dhar Medicine Professional Corporation
RECRUITINGWindsor, Ontario, N8X 5A6, Canada
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Dynamic Drug Advancement Ltd.
RECRUITINGAjax, Ontario, L1S 2J5, Canada
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Gachon University Gil Medical Center
RECRUITINGIncheon, 21565, South Korea
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Greenlane Clinical Centre
RECRUITINGEpsom, Auckland, 1051, New Zealand
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Greenslopes Private Hospital
RECRUITINGGreenslopes, Queensland, 4120, Australia
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Hadassah Medical Center- Ein Kerem - PPDS
RECRUITINGJerusalem, Jerusalem, 9112001, Israel
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Health New Zealand - Te Whatu Ora - Waikato Hospital
RECRUITINGHamilton, Waikato Region, 3240, New Zealand
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Hillel Yaffe Medical Center
RECRUITINGHadera, Haifa District, 3820302, Israel
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IPR-Investigaciones en Patologías Respiratorias
RECRUITINGSan Miguel de Tucumán, Tucumán Province, T4000IAP, Argentina
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IbaMedica
RECRUITINGSanta Fe, S3000ASF, Argentina
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Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
RECRUITINGQuébec, Quebec, G1V 4G5, Canada
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Institute for Respiratory Health
RECRUITINGMidland, Western Australia, 6056, Australia
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Institute of Pulmonary Diseases of Vojvodina
RECRUITINGKamenitz, Syrmia, 21204, Serbia
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Instituto Ave Pulmo
RECRUITINGMar del Plata, Buenos Aires, B7602DCK, Argentina
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Instituto Médico de la Fundación Estudios Clínicos
RECRUITINGRosario, Santa Fe Province, S2000DEJ, Argentina
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Instituto de Especialidades de la Salud Rosario - Clínica del Tórax
RECRUITINGRosario, Santa Fe Province, S2000DBS, Argentina
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Instituto de Medicina Respiratoria - IMER
RECRUITINGCórdoba, X5003DCE, Argentina
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Kaplan Medical Center
RECRUITINGRehovot, Central District, 7661041, Israel
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Korea University Anam Hospital
RECRUITINGSeoul, 2841, South Korea
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Meir Medical Center
RECRUITINGKafr Saba, Central District, 4428164, Israel
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NIHR Leicester Biomedical Research Centre - Glenfield Hospital
RECRUITINGLeicester, England, LE3 9QP, United Kingdom
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Perth Royal Infirmary
RECRUITINGPerth, Scotland, PH1 1NX, United Kingdom
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Rabin Medical Center - PPDS
RECRUITINGPetah Tikva, Central District, 4941492, Israel
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Royal Brompton Hospital
RECRUITINGLondon, SW3 6NP, United Kingdom
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Royal Infirmary of Edinburgh
RECRUITINGEdinburgh, Scotland, EH16 4SA, United Kingdom
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Royal Prince Alfred Hospital
RECRUITINGCamperdown, New South Wales, 2050, Australia
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STAT Research S.A.
RECRUITINGBuenos Aires, C1023AAB, Argentina
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Samsung Medical Center
RECRUITINGSeoul, Seoul, 06351, South Korea
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Seoul National University Bundang Hospital
RECRUITINGSeongnam-si, Gyeonggi-do, 13620, South Korea
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Severance Hospital Yonsei University Health System
RECRUITINGSeoul, Seodaemun, 03722, South Korea
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Shaare Zedek Medical Center
RECRUITINGJerusalem, Yerushala, 9103102, Israel
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Shamir Medical Center
RECRUITINGBe’er Ya‘aqov, Central District, 7033001, Israel
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Soon Chun Hyang University Hospital
RECRUITINGSeoul, Yongsan-gu, 04401, South Korea
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Southampton General Hospital
RECRUITINGSouthampton, Hampshire, SO16 6YD, United Kingdom
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SpiroClinic
RECRUITINGBydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland
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St Bartholomew's Hospital - PPDS
RECRUITINGLondon, Greater London, EC1A 7BE, United Kingdom
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Tel Aviv Sourasky Medical Center Ichilov - PPDS
RECRUITINGTel Aviv, 6423906, Israel
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The Alfred Hospital
RECRUITINGMelbourne, Victoria, 3004, Australia
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The Barzilai University Medical Center
RECRUITINGAshkelon, Southern District, 7830604, Israel
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The Catholic University of Korea - Eunpyeong St. Mary's Hospital
RECRUITINGSeoul, Eunpyeong District, 03312, South Korea
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The Catholic University of Korea, Bucheon St. Mary's Hospital
RECRUITINGBucheon-si, Gyeonggi-do, 14647, South Korea
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The Chaim Sheba Medical Center - PPDS
RECRUITINGRamat Gan, Central District, 5262100, Israel
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The Prince Charles Hospital
RECRUITINGChermside, Queensland, 4032, Australia
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Toronto General Hospital
RECRUITINGToronto, Ontario, M5G 2C4, Canada
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TrialsWest Pty Ltd
RECRUITINGSpearwood, Western Australia, 6163, Australia
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University Clinical Center Kragujevac
RECRUITINGKragujevac, 34000, Serbia
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University Clinical Center Nis
RECRUITINGNiš, 18 000, Serbia
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University Clinical Center of Serbia - Koste Todorovica - PPDS
RECRUITINGBelgrade, 11000, Serbia
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Vancouver General Hospital
RECRUITINGVancouver, British Columbia, V5Z 1M9, Canada
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Westmead Hospital
RECRUITINGWestmead, New South Wales, 2145, Australia
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