Pulmonary HypertensionPhase 3NCT07816185
A Phase 3 Trial of Inhaled Mosliciguat in PH-ILD (PHrontier)
A Phase 3 study testing Mosliciguat and Dry Powder Inhaler in people with Pulmonary Hypertension and Interstitial Lung Disease, run by Pulmovant, Inc. at 3 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Hypertension, Interstitial Lung Disease, Vascular Diseases
- What is being tested?
- Mosliciguat and Dry Powder Inhaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 376 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Aug 2026to 31 Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Idiopathic interstitial pneumonia (IIP)
- Chronic Hypersensitivity pneumonitis
- ILD associated connective tissue disease (CTD)
- Confirmed pulmonary hypertension by right heart catheterization (RHC).
- Ability to perform 6-minute walk distance ≥100 meters.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Clinical Research Site
Bend, Oregon, 97701
Clinical Site
- Recruiting
Clinical Research Site
Kissimmee, Florida, 34746
Clinical Site
- Recruiting
Clinical Research Site
Louisville, Kentucky, 40202
Clinical Site
About this study
Official title: 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
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
Read the detailed description
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.
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease, Vascular Diseases, Cardiovascular Diseases, Fibrosis
- Being tested
- Mosliciguat, Placebo, Dry Powder Inhaler
- Keywords
- PH, ILD, 6 Minute Walk Distance, mosliciguat
- Medical subject headings
- Hypertension, Pulmonary, Lung Diseases, Interstitial, Vascular Diseases, Cardiovascular Diseases, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MosliciguatDrug
Dose level 1, 2, or 3 for inhalation
PlaceboDrug
Matching Placebo for inhalation
Dry Powder InhalerDevice
Administration via dry powder inhaler
| Study group | Role | What they receive |
|---|---|---|
| Mosliciguat | Active comparator | Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks Receives: Drug: Mosliciguat; Device: Dry Powder Inhaler |
| Matched Placebo | Placebo comparator | Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks Receives: Drug: Placebo; Device: Dry Powder Inhaler |
| Extension | Experimental | After Week 24, all participants may receive mosliciguat through an Extension period Receives: Drug: Mosliciguat; Device: Dry Powder Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to Week 24
Secondary outcomes (4)
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).
- Hospitalization >24 hours due to a cardiopulmonary indication
- 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
- Death (all causes)
- Lung transplantation for worsening PH (except when pre-planned prior to the trial)
- Need to initiate additional therapeutic intervention for the treatment of PH
Measured: From randomization through Week 24
Percent Change from Baseline in Pulmonary Vascular Resistance (PVR)
PVR evaluated using right heart catheterization (RHC)
Measured: 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.
Measured: 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).
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start31 Aug 2026
- Primary completion28 Jan 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulmovant, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ubaldo Martin, Study director, Pulmovant, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816185
- Sponsor's protocol ID
- RVT-2301-301
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07816185
- Acronym / sponsor ID
- RVT-2301-301
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease, Vascular Diseases, Cardiovascular Diseases, Fibrosis
- Keywords
- PH, ILD, 6 Minute Walk Distance, mosliciguat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Pulmovant, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 28 Jan 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mosliciguat | Active comparator | Drug: Mosliciguat, Device: Dry Powder InhalerParticipants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks |
| Matched Placebo | Placebo comparator | Drug: Placebo, Device: Dry Powder InhalerParticipants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks |
| Extension | Experimental | Drug: Mosliciguat, Device: Dry Powder InhalerAfter Week 24, all participants may receive mosliciguat through an Extension period |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Confirmed pulmonary hypertension by right heart catheterization (RHC).
- Ability to perform 6-minute walk distance ≥100 meters.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MosliciguatDose level 1, 2, or 3 for inhalation | Drug | Extension, Mosliciguat |
| PlaceboMatching Placebo for inhalation | Drug | Matched Placebo |
| Dry Powder InhalerAdministration via dry powder inhaler | Device | Extension, Matched Placebo, Mosliciguat |
Primary outcome
Change from Baseline in 6-Minute Walk Distance (6MWD)
Time frame: Baseline to Week 24
The 6MWD measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes
4 secondary outcomes
Time to Clinical Worsening (TTCW)
Time frame: From randomization through Week 24
Percent Change from Baseline in Pulmonary Vascular Resistance (PVR)
Time frame: Baseline to Week 24
Change from Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Time frame: Baseline to Week 24
Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score
Time frame: Baseline to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ubaldo Martin study director
Pulmovant, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mosliciguat and Dry Powder Inhaler in people with Pulmonary Hypertension and Interstitial Lung Disease, run by Pulmovant, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pulmovant Inc (+1-919-462-1310, clinicaltrials@pulmovant.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in 6-Minute Walk Distance (6MWD) (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.