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New pill shows promise for scarred lungs in early trial

NCT ID NCT05671835

Disease control Sponsor: Tvardi Therapeutics, Incorporated 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 3 times

Summary

This Phase 2 study tested an experimental oral drug called TTI-101 in 100 people with idiopathic pulmonary fibrosis (IPF), a disease that causes lung scarring and breathing difficulty. Participants took either TTI-101 or a placebo daily for 12 weeks. The main goal was to check safety and side effects, while also measuring how the drug moves through the body. Results will help decide if larger studies are warranted.

What this could mean

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

Active substance
TTI-101
What this could lead to
If successful, this could point toward a new oral treatment option for idiopathic pulmonary fibrosis, a serious lung disease with limited therapies.
What could go wrong
This is an early Phase 2 trial with only 100 participants over 12 weeks. The drug may not show clear benefit or could have side effects. Larger, longer studies are needed.

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

100 people

The number who actually took part.

Started

May 2023

Finished

Aug 2025

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.

Inclusion Criteria: 1. Diagnosed with IPF based on either the 2018 American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/ Latin American Thoracic Association (ALAT) International Diagnostic Guidelines or on the 2022 updated guidelines within 7 years prior to the date of informed consent. 2. Chest high-resolution computed tomography scan (HRCT) performed within 12 months prior to providing informed consent meeting requirements for IPF diagnosis based on 2018 or 2022 ATS/ERS/JRS/ALAT guidelines and confirmed by central review. 3. Greater than 40% of predicted forced vital capacity (FVC) and a ratio of forced expiratory volume in 1 second (FEV1)/FVC ≥0.7 measured pre-bronchodilator during screening confirmed by central review. 4. A predicted diffusing capacity of the lungs for carbon monoxide (DLCO) (hemoglobin \[Hb\] corrected) ≥25% during screening confirmed by central review. 5. Oxygen saturation (SpO2) ≥88% with up to 4L O2/min by pulse oximetry at rest. 6. If currently receiving nintedanib, dose must have been stable for ≥3 months prior to randomization. If participant has previously discontinued nintedanib, there is a 6-week washout period required before screening can begin. 7. Has a life expectancy of at least 12 months. Exclusion Criteria: 1. Unresolved respiratory tract infection within 4 weeks (including coronavirus disease 2019 \[COVID-19\] infections) or an acute exacerbation of IPF within 3 months prior to screening. 2. Planned surgery during the study. 3. The investigator judges that there has been sustained improvement in the severity of IPF during the 12 months prior to screening, based on changes in FVC, DLCO, and/or HRCT scans of the chest. 4. History of other types of respiratory diseases including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that, in the opinion of the investigator, would impact the primary protocol endpoint or ability to do pulmonary function tests (PFTs), or otherwise preclude participation in the study. 5. Likely to have lung transplantation during the study. Note: Participant may be on a lung transplant list if the investigator anticipates the participant will be able to complete the study prior to transplant. 6. Clinically relevant and uncontrolled cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders that may interfere with the participant's ability to complete this study according to the investigator's judgment, or logistical challenges that, in the opinion of the investigator, preclude adequate participation in the study. 7. History or difficulty of swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the study drug. 8. Receiving steroids (excluding topical steroids) in excess of a mean of 10 mg/day of prednisolone or its equivalent within 2 weeks prior to randomization. 9. Received pirfenidone within 3 months prior to randomization. 10. Smoking or vaping of any kind within 3 months of screening.

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

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

Idiopathic pulmonary fibrosis

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Baylor Scott & White Center for Advanced Heart & Lung Disease

    Dallas, Texas, 75246, United States

  • Clinical Trials Center of Middle Tennessee

    Franklin, Tennessee, 37067, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Metroplex Pulmonary and Sleep Center

    McKinney, Texas, 75069, United States

  • New York University Langone Pulmonary and Critical Care Associates

    Brooklyn, New York, 10017, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Pulmonix

    Greensboro, North Carolina, 27403, United States

  • Saint Francis Sleep Allergy and Lung Institute

    Clearwater, Florida, 33765, United States

  • Saint Luke's University Hospital - Bethlehem

    Bethlehem, Pennsylvania, 18020, United States

  • Salem Chest Specialists

    Winston-Salem, North Carolina, 27103-4007, United States

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • The Kirklin Clinic of University of Alabama Birmingham Hospital

    Birmingham, Alabama, 35233, United States

  • The Lung Research Center

    Chesterfield, Missouri, 63017, United States

  • The Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112-2600, United States

  • UHealth - University of Miami Health Systems

    Miami, Florida, 33125, United States

  • University of California Irvine (UCI) Health

    Orange, California, 92868, United States

  • University of California San Diego

    La Jolla, California, 92037, United States

  • University of Chicago Medicine

    Chicago, Illinois, 60637, United States

  • University of Colorado School of Medicine

    Aurora, Colorado, 80045, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Texas Health Science Center at Houston (UT Health)

    Houston, Texas, 77030, United States

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