Can a new injection ease heart and lung strain in obesity?
NCT ID NCT07123779
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 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 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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Heart failure with preserved ejection fraction are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGGreenville, South Carolina, 29605, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can biomarkers predict which elderly heart failure patients will return to hospital?
- Can a daily pill shield hearts in HFpEF?
- A 10-Question survey could give brazilian pulmonary hypertension patients a voice in their care
- Inhaled xenon gas could reveal hidden lung vessel disease without catheter
- Inhaled drug aims to ease dangerous lung blood pressure in scarred lungs
- Implanted device aims to ease heart failure symptoms