NAL ER IPF Respiratory Function and Safety Study

Completed · Phase 1 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

The primary purpose of this study is to assess the safety and tolerability of escalating doses of NAL ER and to evaluate its effect on respiratory function in participants with IPF.

Key facts

Study ID

NCT07036029

Run by

Trevi Therapeutics

People needed

9

Starts

2025-08-21

Expected to finish

2026-06-30

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of IPF as determined by a pulmonologist based on American Thoracic Society (ATS)/ European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Asociación Latinoamericana de Tórax (ALAT) guidelines.
• SpO2 ≥ 92%, taken after at least 5 minutes in a sitting position, undisturbed and non-stimulated - Saturation of Hemoglobin with Oxygen as measured by pulse oximetry.
• FVC ≥ 40% of Global Lung Function Initiative (GLI) 2012 predicted values- Forced Vital Capacity, as determined by spirometry adhering to ATS/ERS guidelines.

You may not qualify if…

• Exacerbation of IPF in the last 3 months.
• Positive results for coronavirus infection (COVID-19) at Day -2, prior to Admission to the clinical research unit (CRU).
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), or an forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) <0.8.
• Currently using any overnight oxygen therapy at any level or delivered by any modality. Intermittent daytime oxygen use of any duration is allowed.
• Diagnosis of sleep disordered breathing (e.g., sleep apnea).
• Upper or lower respiratory tract infection within the 8 weeks prior to admission to the CRU.
• Clinical history of aspiration pneumonitis.
• Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• Medicines Evaluation Unit Ltd. — Manchester, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.