Idiopathic Pulmonary FibrosisPhase 2NCT05671835
Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing TTI-101 in people with Idiopathic Pulmonary Fibrosis, run by Tvardi Therapeutics, Incorporated at 28 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- TTI-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 28 sitesUnited States
- Study dates
- 15 May 2023to 14 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Emory University Hospital
Atlanta, Georgia, 30322
University of Colorado School of Medicine
Aurora, Colorado, 80045
Saint Luke's University Hospital - Bethlehem
Bethlehem, Pennsylvania, 18020
The Kirklin Clinic of University of Alabama Birmingham Hospital
Birmingham, Alabama, 35233
New York University Langone Pulmonary and Critical Care Associates
Brooklyn, New York, 10017
The Medical University of South Carolina
Charleston, South Carolina, 29425
The Lung Research Center
Chesterfield, Missouri, 63017
Northwestern University
Chicago, Illinois, 60611
University of Chicago Medicine
Chicago, Illinois, 60637
Saint Francis Sleep Allergy and Lung Institute
Clearwater, Florida, 33765
Baylor Scott & White Center for Advanced Heart & Lung Disease
Dallas, Texas, 75246
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, 37067
University of Florida
Gainesville, Florida, 32610
Pulmonix
Greensboro, North Carolina, 27403
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
University of Texas Health Science Center at Houston (UT Health)
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of California San Diego
La Jolla, California, 92037
Loyola University Medical Center
Maywood, Illinois, 60153
Metroplex Pulmonary and Sleep Center
McKinney, Texas, 75069
UHealth - University of Miami Health Systems
Miami, Florida, 33125
Tulane University School of Medicine
New Orleans, Louisiana, 70112-2600
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of California Irvine (UCI) Health
Orange, California, 92868
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Salem Chest Specialists
Winston-Salem, North Carolina, 27103-4007
About this study
Official title: REVERT-IPF: A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis
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
- Being tested
- TTI-101, Placebo
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF, TTI-101
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTI-101Drug
Orally via a tablet.
PlaceboDrug
Orally via a tablet.
| Study group | Role | What they receive |
|---|---|---|
| TTI-101 400 mg/day | Experimental | Participants will receive 400 mg/day of TTI-101 twice daily (BID) for 12 weeks. Receives: Drug: TTI-101 |
| TTI-101 800 mg/day | Experimental | Participants will receive 800 mg/day of TTI-101 BID for 12 weeks. Receives: Drug: TTI-101 |
| Placebo | Placebo comparator | Participants will receive a matching placebo BID for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (4)
Maximum Observed Plasma Concentration (Cmax) of TTI-101
Measured: Day 1 to Week 12
Time of Maximum Observed Plasma Concentration (tmax) of TTI-101
Measured: Day 1 to Week 12
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC[0-τ]) of TTI-101
Measured: Day 1 to Week 12
Trough Plasma Concentration (Cτ) of TTI-101
Measured: Day 1 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start15 May 2023
- Primary completion14 Aug 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tvardi Therapeutics, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671835
- Sponsor's protocol ID
- TVD-101-003P
- Status last verified
- Aug 2026
- First submitted
- 3 Jan 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVERT-IPF: A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT05671835
- Acronym / sponsor ID
- TVD-101-003P
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF, TTI-101
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tvardi Therapeutics, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TTI-101 400 mg/day | Experimental | Drug: TTI-101Participants will receive 400 mg/day of TTI-101 twice daily (BID) for 12 weeks. |
| TTI-101 800 mg/day | Experimental | Drug: TTI-101Participants will receive 800 mg/day of TTI-101 BID for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a matching placebo BID for 12 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTI-101Orally via a tablet. | Drug | TTI-101 400 mg/day, TTI-101 800 mg/day |
| PlaceboOrally via a tablet. | Drug | Placebo |
Primary outcome
Number of Participants with an Adverse Event (AE)
Time frame: 16 weeks
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.
4 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of TTI-101
Time frame: Day 1 to Week 12
Time of Maximum Observed Plasma Concentration (tmax) of TTI-101
Time frame: Day 1 to Week 12
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC[0-τ]) of TTI-101
Time frame: Day 1 to Week 12
Trough Plasma Concentration (Cτ) of TTI-101
Time frame: Day 1 to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TTI-101 in people with Idiopathic Pulmonary Fibrosis, run by Tvardi Therapeutics, Incorporated at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with an Adverse Event (AE) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.