RecruitingPhase 2NCT07333183

A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD

An Open-Label, Phase 2 Study Evaluating the Safety of Mosliciguat in Combination With Inhaled Treprostinil in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

Sponsor

Pulmovant, Inc.

Enrollment

20 participants

Start Date

Dec 23, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases Fibrosis Lung Diseases Pulmonary Hypertension Vascular Diseases Interstitial Lung Disease (ILD)

Summary

This is a Phase 2, open-label, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD) on a background inhaled treprostinil.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria8

Participants willing and able to provide informed consent
Participants on inhaled treprostinil
Participants with diagnosis of Interstitial Lung Disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed diseases include:
Idiopathic interstitial pneumonia (IIP)
Chronic hypersensitivity pneumonitis
ILD associated with connective tissue disease (CTD) with a forced vital capacity (FVC) \< 70% of predicted
Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC).
Ability to perform 6MWD ≥100 meters.

Exclusion Criteria6

Diagnosis of PH Group 1 (eg. pulmonary arterial hypertension), Group 2 (related to left-heart dysfunction), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified).
Exacerbation of underlying lung disease within 28 days prior to randomization.
Initiation of pulmonary rehabilitation within 28 days prior to randomization.
Receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
History or intolerance to or lack of efficacy with mosliciguat or sGC stimulators or activators.
Receipt of investigational, or experimental therapy within 42 days OR 5 half-lives prior to randomization.