Recruiting
Phase 3

NAL ER

Sponsor:

Trevi Therapeutics

Code:

NCT07671911

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 Idiopathic Pulmonary Fibrosis (IPF).

Conditions

Idiopathic Pulmonary Fibrosis

Study ID

NCT07671911

Start date

Jun 29, 2026

Status verified date

Oct, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jun, 2028

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.
  • Participants who are currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) approved for IPF 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 2 months prior to Screening.

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

Study Design

Enrollment

306 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 (twice daily \[BID\] dosing with one NAL ER once daily \[QD\] dose and one placebo QD dose) followed by a fixed dose treatment period receiving NAL ER 54 milligrams (mg) BID for 52 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 52 weeks.

Interventions

NAL ER

Oral tablets

Placebo

Oral tablets

Primary outcome measure

  • Relative Change from Baseline in 24-hour Cough Frequency at Week 26 [ Time Frame: Baseline, Week 26 ]

Central Contacts and Locations

Central contacts

Paula Buckley

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

Locations

Newportnativemd, Inc.

Recruiting

Newport Beach, California, United States, 92663-3600

Palmtree Clinical Research

Recruiting

Palm Springs, California, United States, 92262

Paradigm Clinical Research Centers, Inc. - Redding

Recruiting

Redding, California, United States, 96001

Critical Care Pulmonary and Sleep Associates (Ccpsa) - West Clinic

Recruiting

Lakewood, Colorado, United States, 80228

Meris Clinical Research

Recruiting

Brandon, Florida, United States, 33511

Clinical Research Specialists, Llc - Kissimmee

Recruiting

Kissimmee, Florida, United States, 34746-4654

Pulmonary Specialists of The Palm Beaches

Recruiting

Loxahatchee Groves, Florida, United States, 33470

Clinical Research and Associates, Inc.

Recruiting

Miami, Florida, United States, 33126

Coastal Pulmonary & Critical Care, PLC

Recruiting

St. Petersburg, Florida, United States, 33704-2733

Tulane Clinic

Recruiting

New Orleans, Louisiana, United States, 70112

Hannibal Regional Hospital

Recruiting

Hannibal, Missouri, United States, 63401

Renown Regional Medical Center - Center For Advanced Medicine B

Recruiting

Reno, Nevada, United States, 89502

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467-2401

Clinical Research of Gastonia (CRG)

Recruiting

Gastonia, North Carolina, United States, 28054

Southeastern Research Center

Recruiting

Winston-Salem, North Carolina, United States, 27103

Clinical Research Associates of Central, PA, LLC

Recruiting

DuBois, Pennsylvania, United States, 15801

Anmed Medical Center

Recruiting

Anderson, South Carolina, United States, 29621

Horizon Clinical Research Group

Recruiting

Cypress, Texas, United States, 77429

El Paso Pulmonary Association, PA

Recruiting

El Paso, Texas, United States, 79902

Elevate Clinical Research

Recruiting

Houston, Texas, United States, 77058

Intermountain MedicalL Center- PulmonaryY and Critical Care Research

Recruiting

Murray, Utah, United States, 84107

Pulmonary Associates of Richmond Inc (Par) - West Broad Location

Recruiting

Richmond, Virginia, United States, 23230-1710

More Information

Sponsor

Trevi Therapeutics

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Trevi Therapeutics on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.