NCT07333183

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
20mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Dec 2025Jan 2028

Study Start

First participant enrolled

December 23, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

January 8, 2026

Last Update Submit

April 18, 2026

Conditions

Pulmonary HypertensionFibrosisInterstitial Lung Disease (ILD)Lung DiseasesVascular DiseasesCardiovascular Diseases

Keywords

PHILD6 Minute Walk Testmosliciguat

Outcome Measures

Primary Outcomes (1)

  • Incidence and nature of participant TEAEs, SAEs, and AEs leading to discontinuation

    Baseline, Week 16

Study Arms (2)

Active Comparator: inhaled mosliciguat

EXPERIMENTAL

Participants will receive inhaled mosliciguat daily for 16 weeks

Drug: inhaled mosliciguatDevice: Dry Powder Inhaler

Extension: inhaled mosliciguat

EXPERIMENTAL

After Week 16, all participants will continue to receive inhaled mosliciguat through an Extension period

Drug: inhaled mosliciguatDevice: Dry Powder Inhaler

Interventions

inhaled mosliciguatDRUG

Dose level 1, 2, or 3 for inhalation

Active Comparator: inhaled mosliciguatExtension: inhaled mosliciguat
Dry Powder InhalerDEVICE

Dry powder inhaler for mosliciguat delivery

Active Comparator: inhaled mosliciguatExtension: inhaled mosliciguat

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC

Kissimmee, Florida, 34746, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, PulmonaryLung Diseases, InterstitialLung DiseasesVascular DiseasesCardiovascular DiseasesFibrosis

Interventions

Dry Powder Inhalers

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesHypertensionPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nebulizers and VaporizersEquipment and Supplies

Study Officials

  • Ubaldo Martin, MD

    Pulmovant, Inc.

    STUDY DIRECTOR

Central Study Contacts

Pulmovant

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 12, 2026

Study Start

December 23, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

US(1)