A Phase 3 interventional study of Mosliciguat and Placebo in Pulmonary Hypertension, Interstitial Lung Disease and Vascular Diseases, sponsored by Pulmovant, Inc.. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Pulmovant, Inc. · Phase 3, Interventional, and Treatment
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
This study is a randomized double-blind placebo control study with an extension.
The study consists of 2 periods: a blinded placebo-controlled period (24 weeks) and an extension (beyond 24 weeks).
Participants will be randomized to receive mosliciguat or placebo in the 24-week double-blind treatment period.
All participants who complete the 24-week double-blind period may continue to participate in the extension period where all participants receive mosliciguat.
1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.
This study's planned enrollment of 376 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Pulmovant, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Drug: Mosliciguat · Device: Dry Powder Inhaler
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Drug: Placebo · Device: Dry Powder Inhaler
After Week 24, all participants may receive mosliciguat through an Extension period
Drug: Mosliciguat · Device: Dry Powder Inhaler
Dose level 1, 2, or 3 for inhalation
Matching Placebo for inhalation
Administration via dry powder inhaler
Change from Baseline in 6-Minute Walk Distance (6MWD)
The 6MWD measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes
Time frame: Baseline to Week 24
Time to Clinical Worsening (TTCW)
Time from randomization to first occurrence of any of the following events as adjudicated by the independent Event Adjudication Committee (EAC). 1. Hospitalization \>24 hours due to a cardiopulmonary indication 2. Decrease in 6MWD \>15% from baseline directly related to PH-ILD, at two consecutive visits on a different day but no more than 7 days apart 3. Death (all causes) 4. Lung transplantation for worsening PH (except when pre-planned prior to the trial) 5. Need to initiate additional therapeutic intervention for the treatment of PH
Time frame: From randomization through Week 24
Percent Change from Baseline in Pulmonary Vascular Resistance (PVR)
PVR evaluated using right heart catheterization (RHC)
Time frame: Baseline to Week 24
Change from Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
The NT-ProBNP serum concentrations is a useful biomarker associated with changes in right heart morphology and function. NT-proBNP serum concentration will be assessed to compare the severity of heart failure at Baseline and Week 24.
Time frame: Baseline to Week 24
Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score
Change from baseline to Week 24 in L-PF total symptom scores (patient-reported outcome).
Time frame: Baseline to Week 24
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jan 2029, 28 months after the start.
Of 31 phase 3 interventional studies under Hypertension, Pulmonary, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 83. This study's planned 28 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Mosliciguat
Pulmovant, Inc.