Recruiting
Phase 3

Mosliciguat

Sponsor:

Pulmovant, Inc.

Code:

NCT07816185

Conditions

Pulmonary Hypertension

Interstitial Lung Disease

Vascular Diseases

Cardiovascular Diseases

Fibrosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mosliciguat

Placebo

Dry Powder Inhaler

Study Details

Brief summary:

A Phase 3, Multicenter, Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease

Conditions

Pulmonary Hypertension

Interstitial Lung Disease

Vascular Diseases

Cardiovascular Diseases

Fibrosis

Study ID

NCT07816185

Start date

Aug 31, 2026

Status verified date

Sep, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Jan 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants willing and able to provide informed consent.
  • Participants with diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed disease include:

1. Idiopathic interstitial pneumonia (IIP)
2. Chronic Hypersensitivity pneumonitis
3. ILD associated connective tissue disease (CTD)
  • Confirmed pulmonary hypertension by right heart catheterization (RHC).
  • Ability to perform 6-minute walk distance ≥100 meters.

Exclusion Criteria:

  • Diagnosis of PH Group 1 (eg, pulmonary arterial hypertension), Group 2 (related to left heart disease), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified).
  • Exacerbation of underlying lung disease requiring change in therapy or hospitalization within 28 days prior to randomization
  • Receiving >10 L/min oxygen supplementation by any mode of delivery at rest
  • History of intolerance to mosliciguat, or sGC stimulators or activators.
  • Initiation of pulmonary rehabilitation or ongoing acute phase of rehabilitation within 28 days prior to randomization.
  • Receipt of investigational or interventional therapy within 42 days OR 5 half-lives (whichever is longer) prior to randomization.

Study Design

Enrollment

376 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Mosliciguat

Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks

placebo comparator: Matched Placebo

Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks

experimental: Extension

After Week 24, all participants may receive mosliciguat through an Extension period

Interventions

Mosliciguat

Dose level 1, 2, or 3 for inhalation

Placebo

Matching Placebo for inhalation

Dry Powder Inhaler

Administration via dry powder inhaler

Primary outcome measure

  • Change from Baseline in 6-Minute Walk Distance (6MWD) [ Time Frame: Baseline to Week 24 ]

Central Contacts and Locations

Central contacts

Pulmovant Inc

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

Locations

Clinical Research Site

Recruiting

Kissimmee, Florida, United States, 34746

Clinical Research Site

Recruiting

Louisville, Kentucky, United States, 40202

Clinical Research Site

Recruiting

Bend, Oregon, United States, 97701

More Information

Sponsor

Pulmovant, Inc.

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

  • PH
  • ILD
  • 6 Minute Walk Distance
  • mosliciguat

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Pulmovant, Inc. on 2026-09-11.