New pill aims to slow lung scarring in IPF patients

NCT ID NCT07284459

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 324 people

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

Started

Jan 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

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.

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.

  1. The places running it

    72 sites in 11 countries. 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

  • Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS

    RECRUITING

    Papatoetoe, Auckland, 2025, New Zealand

  • Asan Medical Center

    RECRUITING

    Songpa-dong, Seoul, 05505, South Korea

  • Assuta Ashdod University Medical Center

    RECRUITING

    Ashdod, Southern District, 7747629, Israel

  • Austin Health

    RECRUITING

    Heidelberg, Victoria, 3084, Australia

  • Biocinetic Servicios Medicos Ltda

    RECRUITING

    Santiago, Santiago Metropolitan, 8320000, Chile

  • Birmingham Heartlands Hospital

    RECRUITING

    Birmingham, B3 3HX, United Kingdom

  • CEC SpA

    RECRUITING

    Ñuñoa, Santiago Metropolitan, 7750495, Chile

  • CIMER-Centro Integral de Medicina Respiratoria

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, T4000CBC, Argentina

  • CINME S.A. - Centro de Investigaciones Metabólicas - Viamonte 2213/2215

    RECRUITING

    Buenos Aires, Buenos Aires F.D., C1056ABI, Argentina

  • Canterbury Respiratory Research Group

    RECRUITING

    Christchurch, Canterbury, 8001, New Zealand

  • Centre Hospitalier de l'Universite de Montreal

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Centre d'investigation Clinique Mauricie

    RECRUITING

    Trois-Rivières, Quebec City, G8T 7A1, Canada

  • Centro Modelo de Cardiología-Laprida 554

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina

  • Centro Médico Dra de Salvo - Fundacion Respirar - PPDS

    RECRUITING

    Buenos Aires, C1426ABP, Argentina

  • Centro Respiratorio Quilmes

    RECRUITING

    Quilmes, Buenos Aires, B1878FNR, Argentina

  • Centro de Diagnóstico Y Rehabilitación - Santa Fe - San Luis

    RECRUITING

    San Luis, Santa Fe Province, S3000GBL, Argentina

  • Centro de Investigacion Curicó

    RECRUITING

    Curicó, Maule Region, 3341643, Chile

  • Centro de Investigacion de Enfermedades Respiratorias e Inmunologicas

    RECRUITING

    Viña del Mar, Valparaiso, 2520000, Chile

  • Centro de Investigaciones Clinicas Vina del Mar

    RECRUITING

    Viña del Mar, Valparaiso, 2520000, Chile

  • Centro de Investigaciones Médicas Tucumán - PPDS

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • Clinica Internacional - PPDS

    RECRUITING

    Lima, Lima Province, 15001, Peru

  • Consultorios Médicos Organización del Buen Ayre SRL

    RECRUITING

    Buenos Aires, C1425FVH, Argentina

  • Dr. Anil Dhar Medicine Professional Corporation

    RECRUITING

    Windsor, Ontario, N8X 5A6, Canada

  • Dynamic Drug Advancement Ltd.

    RECRUITING

    Ajax, Ontario, L1S 2J5, Canada

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, 21565, South Korea

  • Greenlane Clinical Centre

    RECRUITING

    Epsom, Auckland, 1051, New Zealand

  • Greenslopes Private Hospital

    RECRUITING

    Greenslopes, Queensland, 4120, Australia

  • Hadassah Medical Center- Ein Kerem - PPDS

    RECRUITING

    Jerusalem, Jerusalem, 9112001, Israel

  • Health New Zealand - Te Whatu Ora - Waikato Hospital

    RECRUITING

    Hamilton, Waikato Region, 3240, New Zealand

  • Hillel Yaffe Medical Center

    RECRUITING

    Hadera, Haifa District, 3820302, Israel

  • IPR-Investigaciones en Patologías Respiratorias

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, T4000IAP, Argentina

  • IbaMedica

    RECRUITING

    Santa Fe, S3000ASF, Argentina

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

  • Institute for Respiratory Health

    RECRUITING

    Midland, Western Australia, 6056, Australia

  • Institute of Pulmonary Diseases of Vojvodina

    RECRUITING

    Kamenitz, Syrmia, 21204, Serbia

  • Instituto Ave Pulmo

    RECRUITING

    Mar del Plata, Buenos Aires, B7602DCK, Argentina

  • Instituto Médico de la Fundación Estudios Clínicos

    RECRUITING

    Rosario, Santa Fe Province, S2000DEJ, Argentina

  • Instituto de Especialidades de la Salud Rosario - Clínica del Tórax

    RECRUITING

    Rosario, Santa Fe Province, S2000DBS, Argentina

  • Instituto de Medicina Respiratoria - IMER

    RECRUITING

    Córdoba, X5003DCE, Argentina

  • Kaplan Medical Center

    RECRUITING

    Rehovot, Central District, 7661041, Israel

  • Korea University Anam Hospital

    RECRUITING

    Seoul, 2841, South Korea

  • Meir Medical Center

    RECRUITING

    Kafr Saba, Central District, 4428164, Israel

  • NIHR Leicester Biomedical Research Centre - Glenfield Hospital

    RECRUITING

    Leicester, England, LE3 9QP, United Kingdom

  • Perth Royal Infirmary

    RECRUITING

    Perth, Scotland, PH1 1NX, United Kingdom

  • Rabin Medical Center - PPDS

    RECRUITING

    Petah Tikva, Central District, 4941492, Israel

  • Royal Brompton Hospital

    RECRUITING

    London, SW3 6NP, United Kingdom

  • Royal Infirmary of Edinburgh

    RECRUITING

    Edinburgh, Scotland, EH16 4SA, United Kingdom

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • STAT Research S.A.

    RECRUITING

    Buenos Aires, C1023AAB, Argentina

  • Samsung Medical Center

    RECRUITING

    Seoul, Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    Seoul, Seodaemun, 03722, South Korea

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, Yerushala, 9103102, Israel

  • Shamir Medical Center

    RECRUITING

    Be’er Ya‘aqov, Central District, 7033001, Israel

  • Soon Chun Hyang University Hospital

    RECRUITING

    Seoul, Yongsan-gu, 04401, South Korea

  • Southampton General Hospital

    RECRUITING

    Southampton, Hampshire, SO16 6YD, United Kingdom

  • SpiroClinic

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland

  • St Bartholomew's Hospital - PPDS

    RECRUITING

    London, Greater London, EC1A 7BE, United Kingdom

  • Tel Aviv Sourasky Medical Center Ichilov - PPDS

    RECRUITING

    Tel Aviv, 6423906, Israel

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • The Barzilai University Medical Center

    RECRUITING

    Ashkelon, Southern District, 7830604, Israel

  • The Catholic University of Korea - Eunpyeong St. Mary's Hospital

    RECRUITING

    Seoul, Eunpyeong District, 03312, South Korea

  • The Catholic University of Korea, Bucheon St. Mary's Hospital

    RECRUITING

    Bucheon-si, Gyeonggi-do, 14647, South Korea

  • The Chaim Sheba Medical Center - PPDS

    RECRUITING

    Ramat Gan, Central District, 5262100, Israel

  • The Prince Charles Hospital

    RECRUITING

    Chermside, Queensland, 4032, Australia

  • Toronto General Hospital

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • TrialsWest Pty Ltd

    RECRUITING

    Spearwood, Western Australia, 6163, Australia

  • University Clinical Center Kragujevac

    RECRUITING

    Kragujevac, 34000, Serbia

  • University Clinical Center Nis

    RECRUITING

    Niš, 18 000, Serbia

  • University Clinical Center of Serbia - Koste Todorovica - PPDS

    RECRUITING

    Belgrade, 11000, Serbia

  • Vancouver General Hospital

    RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

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