REVERT Idiopathic Pulmonary Fibrosis Clinical Trial

Phase 2: REVERT IPF Clinical Trial

TTI-101 in Idiopathic Pulmonary Fibrosis
(Currently Recruiting)

A Study of TTI-101 in Participants with Idiopathic Pulmonary Fibrosis

The REVERTIPF clinical trial is evaluating the safety and effectiveness of TTI-101 alone or with nintedanib (OFEV®) in adults with idiopathic pulmonary fibrosis (IPF). The clinical trial will test 3 different doses of TTI-101 compared to a placebo, which looks like but does not contain TTI-101.

TTI-101 is considered an investigational drug, meaning it is not currently approved by the U.S. Food and Drug Administration (FDA). TTI-101 inhibits (or prevents the activity of) STAT3 (signal transducer and activator of transcription 3), a protein that, when activated, plays a key role in the development of fibrosis in patients with IPF. TTI-101 comes in a pill that is taken by mouth twice a day. While nintedanib (OFEV®) is an FDA-approved drug, its use in combination with TTI-101 is considered investigational.

REVERT IPF Clinical Trial Eligibility

To be eligible for the REVERTIPF clinical trial, participants must:

  • Be 40 years of age or older
  • Have had IPF diagnosed within the last 7 years
  • Either not be taking antifibrotic therapy for IPF or be on a stable dose for at least 3 months of nintedanib (OFEV®)
  • Meet additional requirements that will need to be assessed by the clinical trial doctor

REVERT IPF Clinical Trial Participation

A clinical trial doctor at an active location will evaluate participants during a screening period. During this time, participants will visit the clinic and medical assessments will be performed to determine if the participant is eligible to join the trial.

Eligible participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 4 clinical trial treatment groups:

  • TTI-101 – high dose
  • TTI-101 – middle dose
  • TTI-101 – low dose
  • Placebo (a pill which looks like but does not contain TTI-101)

Upon enrollment, participants will receive study therapy for 12 weeks. During treatment, participants will visit the clinic and medical assessments will be performed to evaluate the safety and effects of the treatment.

Clinical Trial Locations and Additional Information

If you are interested in participating and would like to learn more about the clinical trial or to find the U.S. clinical trial location nearest you, click the link below which will redirect you to the website:

Read more about Tvardi Therapeutics’ efforts to prioritize treatment for patients with IPF:

FDA Grants Orphan Drug Designation to TTI-101 for IPF

In 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to TTI-101 as a drug that shows promise in treating IPF. This designation helps to expedite the clinical development of TTI-101.

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