Pulmonary HypertensionWeight managementBiologicalPhase 1, Phase 2
What this study is
Study of HS235 in Overweight and Obese Participants with Combined Pre and Post-Capillary Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction
What's being tested
- HS235
Intervention · BIOLOGICAL
- Placebo
Intervention · OTHER
Both interventions
Subcutaneous Injection
Study details
- Official title
- Phase 1b/2, Multicenter, Double-Blind, Placebo-Controlled, Multiple Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS235 in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
- Sponsor
- 35Pharma Inc., a GSK company
- Conditions
- Pulmonary Hypertension · Heart Failure With Preserved Ejection Fraction
- Enrolling
- 126 people
- Starts
- 2026-10-21
- Est. completion
- 2030-01
- Design
- Quadruple-blind, randomized, sequential groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Male or female, ≥ 18 years of age.
- [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:; 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,; 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.; 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.
- [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:; PVR ≥ 240 dyn*sec/cm5 or ≥ 3 WU, and; mPAP > 20 mmHg, and; PAWP > 15 mmHg but < 30 mmHg, and; dPAP ≥ 15 mmHg.
- 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..
- New York Heart Association (NYHA) class II or III heart failure symptoms.
- Stable diuretic regimen during the screening period.
- Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) < 90 at screening.
- 6-minute walking distance (6MWD) ≥ 100 m at screening.
- Body mass index ≥ 25 to ≤ 50 kg/m2 and Body weight ≤140 kg.
- Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
You can't join if
- Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.
- Occurrence of an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 90 days prior to Screening.
- Implantation of a cardiac resynchronization therapy (CRT) device within 90 days before screening.
- Planned cardiovascular revascularization or planned implantation of CRT device.
- History of heart transplant or on heart transplant list.
- History of serious or life-threatening cardiac arrhythmia within 90 days prior to screening.
- Systemic hypotension or uncontrolled systemic hypertension.
- History of Pericardial constriction or hypertrophic cardiomyopathy.
- History of significant valvular stenosis or regurgitation.
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openInvestigational Site-105
Kansas City, Missouri, United States
RecruitingInvestigational Site-101
Greenville, South Carolina, United States
RecruitingInvestigational Site-103
Dallas, Texas, United States
Recruiting
Study team
Sponsor
35Pharma Inc., a GSK company
Study ID HS235-003
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.