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New lung drug aims to slow scarring in IPF patients

NCT ID NCT05321420

Disease control Sponsor: PureTech Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests a new drug called LYT-100 (deupirfenidone) in 240 adults with idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring and breathing difficulty. Participants receive either LYT-100, the existing drug pirfenidone, or a placebo. The main goal is to see if LYT-100 can slow the decline in lung function over 26 weeks, with fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Deupirfenidone (LYT-100)
What this could lead to
If successful, this could lead to a new treatment option for idiopathic pulmonary fibrosis that slows lung function decline with fewer side effects than current therapies.
What could go wrong
This is a mid-stage trial with 240 participants, so results may not confirm benefit. The drug is similar to an existing treatment, so improvements may be modest. Side effects are still being evaluated.

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 240 people

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

Started

Jul 2022

Expected to finish

Dec 2025

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: * Treatment naïve patients or those with \<6 months of exposure to nintedanib with physician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines * Idiopathic Pulmonary Fibrosis on HRCT, performed within 12 months of Visit 1 as confirmed by central readers * DLCO corrected for Hemoglobin (Hb) \[visit 1\] ≥ 30% and ≤90% of predicted of normal * FVC ≥ 45% of predicted normal Key Exclusion Criteria: * Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC \< 0.7 at Visit 1) * Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer * Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis * Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion) * Cardiovascular diseases, any of the following: * Uncontrolled hypertension, within 3 months of Visit 1 * Myocardial infarction within 6 months of Visit 1 * Unstable cardiac angina within 6 months of Visit 1 * Prior hospitalization for confirmed COVID-19, acute exacerbation of IPF or any lower respiratory tract infection within 3-months of Visit 1

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis pulmonary fibrosis Respiration Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis

Contacts and locations

Locations

  • "Dr. Victor Babes" Clinical Hospital of Infectious Diseases and Pneumophtisiology

    Timișoara, 300312, Romania

  • "Sotiria" Chest Diseases Hospital of Athens

    Athens, 11527, Greece

  • Accel Research Sites Network

    DeLand, Florida, 32720, United States

  • Ahmed Kathrada Lenmed Private Hospital

    Johannesburg, South Africa

  • Apollo Spectra Hospital

    Kanpur, Uttar Pradesh, 208001, India

  • Aprillus Asistencia e Investigación

    Buenos Aires, 1406, Argentina

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Athens Medical Center

    Athens, 15125, Greece

  • BHS Lakeview Heart

    Belagāve, 590016, India

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75204, United States

  • CALPULAB

    Calpulalpan, 90204, Mexico

  • CEMER Centro Medico de Enfermedades Respiratorias

    Buenos Aires, 1602, Argentina

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496, South Korea

  • CIMRO- Centro de Investigación Médica Respiratoria Oncológica

    Mendoza, 5600, Argentina

  • Central Chest Institute Of Thailand

    Nonthaburi, Thailand

  • Centro Médico Dharma

    Mendoza, M5500, Argentina

  • Centro Respiratorio Integral

    Valparaíso, Chile

  • Centro de Estudios Clinicos

    Santiago, 7550000, Chile

  • Centro de Investigaciones Clinicas S.A.S

    Cali, 760036, Colombia

  • Chonnam National University Hospital

    Gwangju, 61469, South Korea

  • Clinica Central S.A.

    Villa Regina, 8336, Argentina

  • Clinica Maule

    Maule, 3530000, Chile

  • Clinica Universidad de Los Andes

    Santiago, 7550000, Chile

  • Clinical Research Investments

    Decatur, Georgia, 30030, United States

  • Clinical Trials Center of Middle Tennessee

    Franklin, Tennessee, 37067, United States

  • Durban Lung Centre

    Durban, 4051, South Africa

  • Emergency Cardiology Center by Academician G. Chapidze LLC

    Tbilisi, 0159, Georgia

  • Fundacion Cardiomet CEQUIN

    Armenia, Colombia

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloniki, 57010, Greece

  • Getwell Hospital and Research Institute

    Nagpur, Maharashtra, 440012, India

  • Government Medical College and Hospital Aurangabad

    Aurangabad, Maharashtra, 431004, India

  • Govt. General and Chest Hospital

    Hyderabad, Telangana, 500038, India

  • Hanyang University - Myongji Hospital

    Goyang-si, Gyeonggi-do, 10475, South Korea

  • Hanyang University Seoul Hospital

    Seoul, 04763, South Korea

  • Harmony Medical Research Institute, Inc

    Hialeah, Florida, 33016, United States

  • Hospital Pulau Pinang

    George Town, 10450, Malaysia

  • Hospital Serdang

    Kajang, Malaysia

  • Hospital Sultanah Bahiyah

    Alor Star, Kedah, 05460, Malaysia

  • Hospital Tengku Ampuan Afzan

    Kuantan, Malaysia

  • Hospital Universitario Dr. José Eleuterio González

    Monterrey, Nuevo León, 64460, Mexico

  • INSARES - Instituto de Salud Respiratoria

    Mendoza, M5500CCG, Argentina

  • InJe University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Institut Perubatan Respiratori

    Kuala Lumpur, Malaysia

  • Instituto Ave Pulmo - Fundacion Enfisema

    Mar del Plata, 7600, Argentina

  • Instituto Médico de la Fundación de Estudios Clinicos / Fundación Estudios

    Rosario, Santa Fe Province, 2000, Argentina

  • Instituto Neumologico del Oriente S.A.

    Bucaramanga, Colombia

  • Instituto de Enfermedades Respiratorias e Investigación Clínica

    San Juan Bautista, 1888, Argentina

  • Instituto de Medicina Respiratoria - IMER

    Córdoba, X5003DCE, Argentina

  • Instituto del Buen Aire

    Santa Fe, 3000, Argentina

  • Integral Health Medical Unit

    San Nicolás de los Garza, Nuevo León, 66465, Mexico

  • Investigaciones en Patologías Respiratorias

    San Miguel de Tucumán, 4000, Argentina

  • Keimyung University - Dongsan Medical Center

    Daegu, 42601, South Korea

  • Khon Kaen University

    Khon Kaen, Thailand

  • Kyung Hee University Hospital

    Seoul, 02447, South Korea

  • LTD Aversi Clinic

    Tbilisi, 0160, Georgia

  • LTD The First Medical Center

    Tbilisi, 0180, Georgia

  • Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

    Torrance, California, 90502, United States

  • Lung Center of the Philippines

    Quezon City, 1100, Philippines

  • Mgm Medical College And Hospital, Aurangabad

    Aurangabad, Maharashtra, 431003, India

  • National Ceneter for Tuberculosis and Lung Diseases JSC

    Tbilisi, 0101, Georgia

  • Netcare Milpark Hospital

    Parktown, 2193, South Africa

  • NewportNativeMD, Inc.

    Newport Beach, California, 92663, United States

  • Nil Ratan Sircar Medical College And Hospital, Kolkata

    Kolkata, West Bengal, 700014, India

  • ONCARE Group

    San Pedro Garza García, 66220, Mexico

  • Oaxaca Site Management Organization

    Oaxaca City, 68000, Mexico

  • Oriion Citicare Super Specialty Hospital

    Aurangabad, Maharashtra, 431005, India

  • Paradigm Clinical Research Centers, Inc.

    Redding, California, 96001, United States

  • Philippine General Hospital

    Manila, 1000, Philippines

  • Piedmont Healthcare, Inc.

    Atlanta, Georgia, 30309, United States

  • Polo de Salud Vistalba

    Mendoza, 1428, Argentina

  • Pulmonary Associates of Richmond

    Richmond, Virginia, 23230, United States

  • Pulmonix

    Greensboro, North Carolina, 27403, United States

  • Renovatio Clinical - The Woodlands Research Center

    The Woodlands, Texas, 77380, United States

  • Respira Salud Clinica Integral

    Godoy Cruz, 5501, Argentina

  • Rhythm Heart Institute Vadodara

    Vadodara, Gujarat, 390022, India

  • Ryexo Clinical Research

    Pretoria, 0084, South Africa

  • S.C. Lavinia Davidescu Clinic SRL

    Oradea, 410163, Romania

  • S.C. Netconsult SRL

    Iași, 700141, Romania

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Science 37

    Los Angeles, California, 90230, United States

  • Siriraj Hospital

    Bangkok, Thailand

  • Songklanagarind Hospital

    Songkhla, Thailand

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103, United States

  • Sparsh Super Specialty Hospital

    Bengaluru, Karnataka, 560001, India

  • St. Luke's Medical Center - Global City

    City of Taguig, 1634, Philippines

  • TPMG Clinical Research

    Williamsburg, Virginia, 23188, United States

  • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC

    Tbilisi, 0144, Georgia

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

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

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

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

    Seoul, 07345, South Korea

  • Ulsan University Hospital

    Ulsan, 44033, South Korea

  • University General Hospital "Attikon"

    Athens, 12462, Greece

  • University General Hospital of Patras

    Pátrai, 26504, Greece

  • University Hospital Alexandroupolis

    Alexandroupoli, 68100, Greece

  • University Malaya Medical Centre

    Kuala Lumpur, Malaysia

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37204, United States

  • WITS Clinical Research

    Johannesburg, 2193, South Africa

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