Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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).

Key facts

Study ID: NCT05671835
Run by: Tvardi Therapeutics, Incorporated
People needed: 100
Starts: 2023-05-15
Expected to finish: 2025-08-14
Last updated by the study team: 2025-09-30

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
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.
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.
A predicted diffusing capacity of the lungs for carbon monoxide (DLCO) (hemoglobin [Hb] corrected) ≥25% during screening confirmed by central review.
Oxygen saturation (SpO2) ≥88% with up to 4L O2/min by pulse oximetry at rest.
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.
Has a life expectancy of at least 12 months.

You may not qualify if…

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.
Planned surgery during the study.
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.
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.
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.
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.
History or difficulty of swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the study drug.
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.
Received pirfenidone within 3 months prior to randomization.
Smoking or vaping of any kind within 3 months of screening.

Where it is running

The Kirklin Clinic of University of Alabama Birmingham Hospital — Birmingham, Alabama, United States
University of California San Diego — La Jolla, California, United States
University of California Irvine (UCI) Health — Orange, California, United States
University of Colorado School of Medicine — Aurora, Colorado, United States
Saint Francis Sleep Allergy and Lung Institute — Clearwater, Florida, United States
University of Florida — Gainesville, Florida, United States
UHealth - University of Miami Health Systems — Miami, Florida, United States
Emory University Hospital — Atlanta, Georgia, United States
Northwestern University — Chicago, Illinois, United States
University of Chicago Medicine — Chicago, Illinois, United States
Loyola University Medical Center — Maywood, Illinois, United States
University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
Tulane University School of Medicine — New Orleans, Louisiana, United States
The Lung Research Center — Chesterfield, Missouri, United States
New York University Langone Pulmonary and Critical Care Associates — Brooklyn, New York, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Pulmonix — Greensboro, North Carolina, United States
Salem Chest Specialists — Winston-Salem, North Carolina, United States
Saint Luke's University Hospital - Bethlehem — Bethlehem, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Temple University Hospital — Philadelphia, Pennsylvania, United States
The Medical University of South Carolina — Charleston, South Carolina, United States
Clinical Trials Center of Middle Tennessee — Franklin, Tennessee, United States
Baylor Scott & White Center for Advanced Heart & Lung Disease — Dallas, Texas, United States
Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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