HS235 study in overweight and obese people with a specific type of heart failure-related lung pressure problem

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Phase 1b/2, multicenter, double-blind, placebo-controlled, multiple-dose trial evaluating the pharmacokinetics, safety, pharmacodynamics, and efficacy of HS235 in adults with overweight or obesity and combined pre- and post-capillary pulmonary hypertension due to heart failure with preserved ejection fraction. The trial will compare HS235 to placebo across multiple dosing cohorts, with detailed assessments of hemodynamics and clinical outcomes. Participants may be enrolled if they meet the hemodynamic criteria and, for sub-population A, have an ambulatory pulmonary arterial pressure monitor implanted as part of standard care. The study is conducted at three investigational sites in the United States and is sponsored by 35Pharma Inc., a GSK company.

Why it matters

Who can join: the full rules

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 by the ambulatory PAP monitoring system 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 by the ambulatory PAP monitoring system in supine position by the averaged 7-day values (weekly average) 2 weeks and 1 week before Randomization.
   3. Hemodynamic evidence of pre-capillary PH based on presence of PVR ≥ 240 dyn\*sec/cm5 or ≥ 3 WU obtained on most recent RHC obtained prior to screening.
3. \[Sub-population B only - without a remote PAP sensor\]

   Hemodynamic evidence of Cpc-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 ≥ 25 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 untreated mild obstructive sleep apnea (OSA).

Where it's running

• Investigational Site-105
  Kansas City, Missouri, United States Recruiting
• Investigational Site-101
  Greenville, South Carolina, United States Recruiting
• Investigational Site-103
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pulmonary Artery Denervation for a specific type of heart and lung pressure problem

  This study tests whether the Enhancor System can safely and effectively help patients with combined pre- and post-capillary pulmonary hypertension due to left heart disease when added to standard therapy.

  Recruiting at 18 sites Pulnovo Medical, Inc. · Tucson, Arizona and 18 other locations · NCT07214376

• Remote rehabilitation for HFpEF patients using telerehabilitation

  A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.

  Recruiting at 3 sites American Heart of Poland · Chrzanów and 2 other locations · NCT07918209

• Levosimendan to see if it helps the heart after PEA in CTEPH

  This small randomized trial tests whether giving levosimendan around surgery helps reduce pulmonary artery pressure and support right heart function after pulmonary endarterectomy for CTEPH.

  Recruiting Meshalkin Research Institute of Pathology of Circulation · Novosibirsk · NCT07914933

• Early treatment with inhaled treprostinil for exercise-induced pulmonary hypertension in ILD or CTD

  This study tests whether inhaled treprostinil added to standard care can improve exercise-related lung blood flow and function in adults with ILD or CTD who develop pulmonary hypertension during exercise.

  Recruiting at 2 sites Early Phase 1 Valley Health System · Paramus, New Jersey and 1 other locations · NCT07837830

• Brazilian Portuguese version of EmPHasis-10 for pulmonary hypertension

  This study tests a Brazilian Portuguese version of the EmPHasis-10 questionnaire to see if it reliably measures quality of life in adults with pulmonary hypertension in Porto Alegre, Brazil.

  Recruiting Hospital de Clinicas de Porto Alegre · Porto Alegre · NCT07822997

• Inhaled mosliciguat for pulmonary hypertension in interstitial lung disease (PH-ILD) patients

  This study tests inhaled mosliciguat versus placebo in people with PH-ILD to see if it helps with their condition.

  Recruiting at 3 sites Phase 3 Pulmovant, Inc. · Kissimmee, Florida and 2 other locations · NCT07816185

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.