Study of HS235 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (HFpEF)

Last updated: August 8, 2025
Sponsor: 35Pharma Inc
Overall Status: Active - Not Recruiting

Phase

1

Condition

Heart Failure

Pulmonary Arterial Hypertension

Lung Disease

Treatment

Placebo

HS235

Clinical Study ID

NCT07123779
HS235-003
  • Ages > 18
  • All Genders

Study Summary

Study of HS235 in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction Utilizing Ambulatory Pulmonary Artery Pressure Monitoring

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients 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. Ambulatory pulmonary artery pressure (PAP) monitoring (e.g. CardioMEMS™ HF System orCordella™ HF System) implanted in the course of standard of care at least 90 daysbefore Screening with mean pulmonary artery pressure (mPAP) ≥ 25 mmHg and diastolicpulmonary artery pressure(dPAP) ≥ 15 mmHg as averaged over the last 2 weeks prior toRandomization.

  3. Established diagnosis of HFpEF with left ventricular ejection fraction (LVEF) ≥ 45 %as measured by echocardiography during Screening.

  4. New York Heart Association (NYHA) class II or III heart failure symptoms.

  5. Stable diuretic regimen during the screening period.

  6. Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) < 90 atscreening.

  7. 6-minute walking distance (6MWD) ≥ 100 m at screening.

  8. Body mass index ≥ 30 to ≤ 50 kg/m2 and Body weight ≤140 kg.

  9. Ability to adhere to study visit schedule and understand and comply with allprotocol requirements.

Exclusion

Exclusion Criteria:

  1. Hospitalization for any worsening medical condition or major surgery within 4 weeksprior to screening.

  2. Occurrence of an acute coronary syndrome, percutaneous coronary intervention, orcardiac surgery within 90 days prior to Screening.

  3. Implantation of a cardiac resynchronization therapy (CRT) device within 90 daysbefore 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 toscreening.

  7. Systemic hypotension or uncontrolled systemic hypertension.

  8. History of Pericardial constriction or hypertrophic cardiomyopathy.

  9. History of significant valvular stenosis or regurgitation.

  10. Patients with a pneumonectomy or more than moderate Chronic Obstructive PulmonaryDisease (COPD) or mild interstitial lung disease (ILD) or mild obstructive sleepapnea (OSA).

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
September 01, 2025
Estimated Completion Date:
September 30, 2028

Study Description

A Phase Ib, Multicenter, Double-Blind, Placebo-Controlled, Multiple Ascending Dose (MAD) Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS235 in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction Utilizing Ambulatory Pulmonary Artery Pressure Monitoring