A Study of Mosliciguat in Combination With Inhaled Trepro... | NCT07333183

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

NCT07333183

Sponsor

Pulmovant, Inc.

Status

Recruiting

Last Update Posted

Apr 22, 2026Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

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

Interventions

inhaled mosliciguat
Dry Powder Inhaler

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 23, 2025Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Jan 2028Estimated

First Submitted Date

Jan 8, 2026

First Submission Date that Met QC Criteria

Jan 9, 2026

First Posted Date

Jan 12, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2026

Last Update Posted Date

Apr 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Comparator: inhaled mosliciguat	Experimental	Participants will receive inhaled mosliciguat daily for 16 weeks	Drug: inhaled mosliciguat Device: Dry Powder Inhaler
Extension: inhaled mosliciguat	Experimental	After Week 16, all participants will continue to receive inhaled mosliciguat through an Extension period	Drug: inhaled mosliciguat Device: Dry Powder Inhaler

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inhaled mosliciguat	Drug	Dose level 1, 2, or 3 for inhalation	Active Comparator: inhaled mosliciguat Extension: inhaled mosliciguat

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

Eligibility Module

Eligibility Criteria

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 exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Pulmovant	Contact	+1-919-462-1310		clinicaltrials@pulmovant.com

Name	Affiliation	Role
Ubaldo Martin, MD	Pulmovant, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC	Recruiting	Kissimmee	Florida	34746	United States

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D005355	Fibrosis

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D006973	Hypertension
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D009330	Nebulizers and Vaporizers
D004864	Equipment and Supplies