Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis

Last updated: May 20, 2025
Sponsor: Tvardi Therapeutics, Incorporated
Overall Status: Active - Not Recruiting

Phase

2

Condition

Idiopathic Pulmonary Fibrosis

Lung Injury

Lung Disease

Treatment

Placebo

TTI-101

Clinical Study ID

NCT05671835
TVD-101-003P
  • Ages > 40
  • All Genders

Study Summary

The primary objective of this study is to evaluate the safety and tolerability of oral daily administration of TTI-101 over a 12-week treatment duration in participants with idiopathic pulmonary fibrosis (IPF).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed with IPF based on either the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/ LatinAmerican 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 monthsprior 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 forcedexpiratory volume in 1 second (FEV1)/FVC ≥0.7 measured pre-bronchodilator duringscreening 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 torandomization. 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

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 toscreening.

  2. Planned surgery during the study.

  3. The investigator judges that there has been sustained improvement in the severity ofIPF during the 12 months prior to screening, based on changes in FVC, DLCO, and/orHRCT scans of the chest.

  4. History of other types of respiratory diseases including diseases or disorders ofthe airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wallthat, in the opinion of the investigator, would impact the primary protocol endpointor ability to do pulmonary function tests (PFTs), or otherwise precludeparticipation in the study.

  5. Likely to have lung transplantation during the study. Note: Participant may be on alung transplant list if the investigator anticipates the participant will be able tocomplete the study prior to transplant.

  6. Clinically relevant and uncontrolled cardiac, hepatic, gastrointestinal, renal,endocrine, metabolic, neurologic, or psychiatric disorders that may interfere withthe participant's ability to complete this study according to the investigator'sjudgment, 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 chronicgastrointestinal disease or conditions that may hamper compliance and/or absorptionof the study drug.

  8. Receiving steroids (excluding topical steroids) in excess of a mean of 10 mg/day ofprednisolone 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.

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
May 15, 2023
Estimated Completion Date:
August 25, 2025

Connect with a study center

  • The Kirklin Clinic of University of Alabama Birmingham Hospital

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Pulmonary Associates PA

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • University of California San Diego

    La Jolla, California 92037
    United States

    Site Not Available

  • University of California Irvine (UCI) Health

    Orange, California 92868
    United States

    Site Not Available

  • University of California San Diego

    San Diego, California 92037
    United States

    Site Not Available

  • University of Colorado School of Medicine

    Aurora, Colorado 80045
    United States

    Site Not Available

  • MedStar Georgetown University Hospital

    Georgetown, District of Columbia 20007
    United States

    Site Not Available

  • Saint Francis Sleep Allergy and Lung Institute

    Clearwater, Florida 33765
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • UHealth - University of Miami Health Systems

    Miami, Florida 33125
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Chicago Medicine

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Northwestern University

    Evanston, Illinois 60208
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Tulane University School of Medicine

    New Orleans, Louisiana 70112-2600
    United States

    Site Not Available

  • Minnesota Lung Center

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Minnesota Lung Center

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • The Lung Research Center

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Somnos Clinical Research

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • New York University Langone Pulmonary and Critical Care Associates

    Brooklyn, New York 10017
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Pulmonix

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • Salem Chest Specialists

    Winston-Salem, North Carolina 27103-4007
    United States

    Site Not Available

  • Saint Luke's University Hospital - Bethlehem

    Bethlehem, Pennsylvania 18020
    United States

    Site Not Available

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • The Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Clinical Trials Center of Middle Tennessee

    Franklin, Tennessee 37067
    United States

    Site Not Available

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

    Dallas, Texas 75246
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

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

    Houston, Texas 77030
    United States

    Site Not Available

  • Metroplex Pulmonary and Sleep Center

    McKinney, Texas 75069
    United States

    Site Not Available

  • Inova Fairfax Medical Campus

    Falls Church, Virginia 22042
    United States

    Site Not Available

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