Study of HS135 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

35Pharma Inc

Status and phase: Enrolling; Phase 1

Conditions: Heart Failure With Preserved Ejection Fraction; Pulmonary Hypertension

Treatments: Other: Placebo; Biological: HS135

Study type: Interventional

Funder types: Industry

Identifiers

NCT06581159

HS135-003

Details and patient eligibility

About

A Study of HS135 for the Treatment of in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

Full description

Phase 1b, Multicenter, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction

Enrollment: 30 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. CardioMEMS™ Heart Failure System implanted during standard of care at least 90 days before Screening.
3. Established diagnosis of HFpEF with Left Ventricular Ejection Fraction (LVEF) at least 45% as measured by echocardiography during Screening.
4. New York Heart Association (NYHA) class II, III or IV heart failure symptoms.
5. BMI ≥ 30 kg/m2.
6. Ability to adhere to study visit schedule and understand and comply with all protocol requirements.

Exclusion criteria

Patients will be excluded from the study if they meet any of the following criteria:

1. Decompensated heart failure.
2. Admission for an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 30 days prior to Screening.
3. Implantation of cardiac resynchronization therapy (CRT) device within 90 days prior to Screening.
4. Planned cardiovascular revascularization or major cardiac surgery or planned implantation of CRT device.
5. History of heart transplant or on heart transplant list.
6. Uncontrolled systemic hypertension.
7. Patients who have an abnormality in echocardiography or electrocardiogram that in the opinion of the investigator increases the risk of participating in the study.
8. Patients who have full pneumonectomy or a severe chronic pulmonary disorder that in the opinion of the investigator increases the risk of participating in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Investigational Product

Experimental group

Description:

HS135 Subcutaneous Injection

Treatment:

Biological: HS135

Placebo

Placebo Comparator group

Description:

Subcutaneous Injection

Treatment:

Other: Placebo