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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07333183

Enrollment

Registered

2026-01-12

Start date

2025-12-23

Completion date

2028-01-31

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

PH, ILD, 6 Minute Walk Test, mosliciguat

Brief 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.

Detailed description

This study is an open-label study with an extension. The study consists of 2 periods: an open label treatment period (16 weeks) and an extension (beyond 16 weeks). Participants will receive mosliciguat in the 16-week treatment period. All participants who complete the 16-week treatment period may continue to participate in the extension period where all participants will receive mosliciguat.

Interventions

DRUGinhaled mosliciguat

Dose level 1, 2, or 3 for inhalation

DEVICEDry Powder Inhaler

Dry powder inhaler for mosliciguat delivery

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* 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: 1. Idiopathic interstitial pneumonia (IIP) 2. Chronic hypersensitivity pneumonitis 3. 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 criteria

* 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. Note: Other inclusion and

Design outcomes

Primary

Measure	Time frame
Incidence and nature of participant TEAEs, SAEs, and AEs leading to discontinuation	Baseline, Week 16

Countries

United States

Contacts

Primary ContactPulmovant

clinicaltrials@pulmovant.com+1-919-462-1310

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026