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

35Pharma Inc

Status and phase: Not yet enrolling; Phase 1

Conditions: Heart Failure With Preserved Ejection Fraction; Pulmonary Hypertension

Treatments: Other: Placebo; Biological: HS235

Study type: Interventional

Funder types: Industry

Identifiers

NCT07123779

HS235-003

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Investigational Product

Experimental group

Description:

HS235 Subcutaneous Injection

Treatment:

Biological: HS235

Placebo

Placebo Comparator group

Description:

Subcutaneous Injection

Treatment:

Other: Placebo