Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis

NCT05671835 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: TVD-101-003P
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 28

Brief 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).

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; IPF; TTI-101

Outcome Measures

Primary Outcomes (1)

• Number of Participants with an Adverse Event (AE)

  Incidence of AEs, including serious AEs assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V.5.0. Clinically significant changes between baseline and postbaseline laboratory assessments, electrocardiograms, vital signs, and physical examinations will be recorded as AEs.

  16 weeks

Secondary Outcomes (4)

• Maximum Observed Plasma Concentration (Cmax) of TTI-101

  Day 1 to Week 12

• Time of Maximum Observed Plasma Concentration (tmax) of TTI-101

  Day 1 to Week 12

• Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC[0-τ]) of TTI-101

  Day 1 to Week 12

• Trough Plasma Concentration (Cτ) of TTI-101

  Day 1 to Week 12

Study Arms (3)

TTI-101 400 mg/day

EXPERIMENTAL

Participants will receive 400 mg/day of TTI-101 twice daily (BID) for 12 weeks.

Drug: TTI-101

TTI-101 800 mg/day

EXPERIMENTAL

Participants will receive 800 mg/day of TTI-101 BID for 12 weeks.

Drug: TTI-101

Placebo

PLACEBO COMPARATOR

Participants will receive a matching placebo BID for 12 weeks.

Drug: Placebo

Interventions

TTI-101 DRUG

Orally via a tablet.

TTI-101 400 mg/day; TTI-101 800 mg/day

Placebo DRUG

Orally via a tablet.

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Tvardi Therapeutics, Incorporated: lead

Study Sites (28)

The Kirklin Clinic of University of Alabama Birmingham Hospital

Birmingham, Alabama, 35233, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

University of California Irvine (UCI) Health

Orange, California, 92868, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Saint Francis Sleep Allergy and Lung Institute

Clearwater, Florida, 33765, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

UHealth - University of Miami Health Systems

Miami, Florida, 33125, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112-2600, United States

Location

The Lung Research Center

Chesterfield, Missouri, 63017, United States

Location

New York University Langone Pulmonary and Critical Care Associates

Brooklyn, New York, 10017, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Pulmonix

Greensboro, North Carolina, 27403, United States

Location

Salem Chest Specialists

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

Location

Saint Luke's University Hospital - Bethlehem

Bethlehem, Pennsylvania, 18020, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

The Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Clinical Trials Center of Middle Tennessee

Franklin, Tennessee, 37067, United States

Location

Baylor Scott & White Center for Advanced Heart & Lung Disease

Dallas, Texas, 75246, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

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

Houston, Texas, 77030, United States

Location

Metroplex Pulmonary and Sleep Center

McKinney, Texas, 75069, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

C188-9 compound

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: May 15, 2023
• Primary Completion: August 14, 2025
• Study Completion: August 14, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)