Study of HS235 in Overweight and Obese Participants with Combined Pre and Post-Capillary Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction
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.
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.
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.
Sequential
HS235
Biological/VaccineSubcutaneous Injection
Placebo
Other interventionSubcutaneous Injection
Incidence and Number of Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The incidence and number of participants who experience an AE will be reported.
Click on the lead sponsor to view all of their trials.
