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

NCT ID: NCT07123779

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-09-30

Brief Summary

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

Detailed 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

Conditions

Pulmonary Hypertension; Heart Failure With Preserved Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Investigational Product

HS235 Subcutaneous Injection

Group Type: EXPERIMENTAL

HS235

Intervention Type: BIOLOGICAL

Subcutaneous Injection

Placebo

Subcutaneous Injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Subcutaneous Injection

Interventions

HS235

Subcutaneous Injection

Intervention Type: BIOLOGICAL

Placebo

Subcutaneous Injection

Intervention Type: OTHER

Eligibility Criteria

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 or Cordella™ HF System) implanted in the course of standard of care at least 90 days before Screening with mean pulmonary artery pressure (mPAP) ≥ 25 mmHg and diastolic pulmonary artery pressure(dPAP) ≥ 15 mmHg as averaged over the last 2 weeks prior to Randomization.

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 at screening.

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 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. Patients with a pneumonectomy or more than moderate Chronic Obstructive Pulmonary Disease (COPD) or mild interstitial lung disease (ILD) or mild obstructive sleep apnea (OSA).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

35Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monique Champagne, M.Sc

Role: STUDY_DIRECTOR

35Pharma Inc

Central Contacts

Roxanne Julien, M.Sc

Role: CONTACT

clinicaltrials@35pharma.com

438-439-9168

Other Identifiers

HS235-003

Identifier Type: -

Identifier Source: org_study_id