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NCT05671835 · ClinicalTrials.gov registry record · Phase 2

Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis

A Phase 2 study, sponsored by Tvardi Therapeutics, Incorporated.

Completed
Registry status
Phase 2
Development phase
100
Enrollment target

NCT05671835: Completed Phase 2 study, sponsored by Tvardi Therapeutics, Incorporated.

NCT05671835 is a Phase 2 study that has completed, run by Tvardi Therapeutics, Incorporated. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05671835, a Phase 2 study, has completed, sponsored by Tvardi Therapeutics, Incorporated.

COMPLETED
Registry status
Phase 2
Development phase
100 participants
Enrollment target

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).

Primary Outcome

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.

Interventions

  • DRUG Placebo
  • DRUG TTI-101

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-05-15
Est. Completion 2025-08-14
Phase Phase 2

What the finished NCT05671835 record still lists

NCT05671835 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05671835 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05671835 about?

NCT05671835 is a clinical study titled "Study 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).

What is the current status of trial NCT05671835?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2023-05-15. Estimated completion is 2025-08-14.

What interventions are being tested in trial NCT05671835?

The interventions under investigation include: Placebo (DRUG), TTI-101 (DRUG).

Who is sponsoring clinical trial NCT05671835?

This trial is sponsored by Tvardi Therapeutics, Incorporated, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05671835's enrollment target sits among peer trials

100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05671835, the US trial registry maintained by the National Library of Medicine. NCT05671835 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.