Can a new injection slow pulmonary arterial hypertension?
NCT ID NCT07143448
First seen Aug 17, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This trial is testing an experimental drug called HS235, given as a shot under the skin, in adults with pulmonary arterial hypertension (PAH), a condition where high blood pressure in the lungs makes it hard to breathe and can strain the heart. The study aims to see if adding HS235 to standard PAH treatments is safe and helps improve how well patients function. About 90 adults will be randomly assigned to receive either HS235 or a placebo, with different doses being evaluated. The main focus is on safety and how the drug affects the body, with the hope that it may offer a new way to manage this serious disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HS235, an experimental activin signaling inhibitor given as a subcutaneous injection
- What this could lead to
- If successful, HS235 could offer a new add-on treatment to help manage pulmonary arterial hypertension, potentially improving exercise capacity and slowing disease progression.
- What could go wrong
- This is an early-phase trial with a small number of participants, so safety and effectiveness are not yet established. The drug may not work better than placebo, and side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Participants are eligible to be included in the study only if they meet all of the following criteria: 1. Male and female participants, 18 years of age and older. 2. Body Mass Index (BMI) 18.5 and 40 kg/m2 and body weight at or below 120 kg. 3. Baseline RHC performed during the Screening Period documenting: 1. A minimum PVR of ≥ 5 Wood units (WU) or ≥ 400 dyn·sec·cm-5 and, 2. A pulmonary artery wedge pressure (PAWP) of ≤ 15 mm Hg. 4. Diagnosis of WHO pulmonary arterial hypertension (PAH) Group 1. 5. Symptomatic PAH classified as WHO Functional class II to IV. 6. On stable doses of at least 2 approved background PAH therapies and diuretics. 7. 6-Minute Walk Distance (6MWD) ≥ 150 m and ≤ 500 m repeated twice during screening. 8. Ability to adhere to study visit schedule and understand and comply with all protocol requirements. Exclusion Criteria: 1. PH WHO Groups 2, 3, 4 or 5. 2. Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening. 3. Any symptomatic coronary disease events. 4. History of heart transplant or on heart transplant list. 5. Uncontrolled systemic hypertension. 6. History of restrictive, constrictive or congestive cardiomyopathy. 7. History of significant mitral regurgitation or aortic regurgitation valvular disease. 8. Untreated or poorly controlled moderate or severe obstructive sleep apnea. 9. A diagnosis of worse than moderate COPD or worse than mild ILD. 10. Cerebrovascular event within 90 days prior to screening 11. A pneumonectomy or lobectomy 12. Having received an activin signaling inhibitor such as sotatercept at any time prior to screening 13. A Hgb \> sex-specific ULN 14. Platelets count \< 100,000/mm3 15. Severe (stage ≥4) renal failure with eGFR \< 30 mL/min/m2 16. Abnormally elevated liver function enzymes (ALT or AST \> 3X ULN, or total bilirubin \> 1.5X ULN).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Investigational Site-102
RECRUITINGTampa, Florida, 33620, United States
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Investigational Site-104
RECRUITINGProvidence, Rhode Island, 02903, United States
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Investigational Site-305
RECRUITINGBarcelona, 08035, Spain
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Investigational Site-903
RECRUITINGLondon, London, W12 0HS, United Kingdom
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