Recruiting
Phase 3

NAL ER

Sponsor:

Trevi Therapeutics

Code:

NCT07868419

Conditions

Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

NAL ER

Placebo

Study Details

Brief summary:

The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with IPF.

Conditions

Idiopathic Pulmonary Fibrosis

Study ID

NCT07868419

Start date

Sep 30, 2026

Status verified date

Oct, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of IPF as determined by the Investigator based on American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) clinical practice guidelines.
  • Chronic cough for ≥8 weeks prior to Screening.
  • PGI-Severity Score ≥ 2 at Screening.
  • Forced vital capacity (FVC) ≥40 percent (%) of predicted at Screening.
  • Diffusing capacity for carbon monoxide (DLCO) ≥25% of predicted during Screening or within 12 weeks prior to Screening.
  • If currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) should be on a stable dose for at least 6 weeks prior to the Baseline Visit.

Exclusion Criteria:

  • Clinical diagnosis or clinical suspicion of an upper or lower respiratory tract infection in the last 8 weeks prior to the Screening visit or during Screening.
  • Hospitalization for any respiratory illness (including acute exacerbation of IPF) within 8 weeks prior to Screening.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Enrollment

201 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NAL ER 54 mg

Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving NAL ER 54 milligrams (mg) twice daily (BID) for 12 weeks.

placebo comparator: Placebo

Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving a matching placebo BID for 12 weeks.

Interventions

NAL ER

Oral tablets

Placebo

Oral tablets

Primary outcome measure

  • Relative Change from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo [ Time Frame: Baseline, Week 14 ]

Central Contacts and Locations

Central contacts

Paula Buckley

(203) 304-2499Paula.Buckley@trevitherapeutics.com

Locations

Premier Medical Associates, LLC

Recruiting

Wilmington, Delaware, United States, 19803

Essential Health and Research Services

Recruiting

North Miami Beach, Florida, United States, 33162

American Health Research - Charlotte Location

Recruiting

Charlotte, North Carolina, United States, 28277

Hillcroft Medical Clinic

Recruiting

Sugar Land, Texas, United States, 77478

More Information

Sponsor

Trevi Therapeutics

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Trevi Therapeutics on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.