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Can a new injection slow pulmonary arterial hypertension?

NCT ID NCT07143448

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    4 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Investigational Site-102

    RECRUITING

    Tampa, Florida, 33620, United States

  • Investigational Site-104

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Investigational Site-305

    RECRUITING

    Barcelona, 08035, Spain

  • Investigational Site-903

    RECRUITING

    London, London, W12 0HS, United Kingdom

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