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Can a new injection ease heart and lung strain in obesity?

NCT ID NCT07123779

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Updated 1 time

Summary

This trial is testing an experimental drug called HS235 in obese adults who have both pulmonary hypertension and heart failure with preserved ejection fraction. The study aims to see if the drug is safe, how it moves through the body, and whether it can improve heart and lung function. Participants will receive either HS235 or a placebo as a subcutaneous injection, and researchers will monitor for side effects and measure the drug's effects.

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 biologic given as a subcutaneous injection
What this could lead to
If successful, HS235 could offer a new treatment option for obese people with pulmonary hypertension and heart failure with preserved ejection fraction, potentially improving symptoms and quality of life.
What could go wrong
This is an early-phase trial, so the drug may not work as hoped or could cause side effects. Results from a small group may not apply to everyone.

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 126 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

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 at least all the following criteria: 1. Male or female, ≥ 18 years of age. 2. \[Sub-population A only - using a remote PAP sensor\]- Ambulatory PAP monitoring (e.g., CardioMEMS™ HF System or Cordella™ HF System) implanted in the course of standard of care at least 90 days before Screening. Hemodynamic evidence of PH with: 1. mPAP ≥ 25 mm Hg, as measured in supine position by the averaged 7-day values (weekly average) 2 weeks and 1 week before Randomization AND, 2. dPAP ≥ 15 mm Hg, as measured in supine position by the averaged 7-day values (weekly average) 2 weeks and 1 week before Randomization. 3. \[Sub-population B only - without a remote PAP sensor\] Hemodynamic evidence of PH based on the presence of all the following RHC parameters obtained during the Screening period, prior to randomization: 1. PVR ≥ 240 dyn\*sec/cm5 or ≥ 3 WU, and 2. mPAP \> 20 mmHg, and 3. PAWP \> 15 mmHg but \< 30 mmHg, and 4. dPAP ≥ 15 mmHg. 4. Established diagnosis of HFpEF with left ventricular ejection fraction (LVEF) ≥ 45 % as measured by echocardiography during Screening and and no documented LVEF \< 45% during the 2 years preceding Screening.. 5. New York Heart Association (NYHA) class II or III heart failure symptoms. 6. Stable diuretic regimen during the screening period. 7. Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) \< 90 at screening. 8. 6-minute walking distance (6MWD) ≥ 100 m at screening. 9. Body mass index ≥ 30 to ≤ 50 kg/m2 and Body weight ≤140 kg. 10. Ability to adhere to study visit schedule and understand and comply with all protocol requirements. Exclusion Criteria: 1. Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening. 2. Occurrence of an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 90 days prior to Screening. 3. Implantation of a cardiac resynchronization therapy (CRT) device within 90 days before screening. 4. Planned cardiovascular revascularization or planned implantation of CRT device. 5. History of heart transplant or on heart transplant list. 6. History of serious or life-threatening cardiac arrhythmia within 90 days prior to screening. 7. Systemic hypotension or uncontrolled systemic hypertension. 8. History of Pericardial constriction or hypertrophic cardiomyopathy. 9. History of significant valvular stenosis or regurgitation. 10. Participants with a pneumonectomy or more than moderate Chronic Obstructive Pulmonary Disease (COPD) or mild interstitial lung disease (ILD) or mild obstructive sleep apnea (OSA).

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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

    1 site. 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-101

    RECRUITING

    Greenville, South Carolina, 29605, United States

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