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

Phase 1TerminatedNCT06581159

35Pharma Inc4 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Heart Failure With Preserved Ejection Fraction Pulmonary Hypertension

Interventions

HS135BIOLOGICAL

Subcutaneous Injection

PlaceboOTHER

Subcutaneous Injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Site-104

Phoenix, Arizona, United States

Site-105

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

Incidence and Number of Adverse Events (AEs)

An AE is any untoward medical occurrence in a patient or clinical trial patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The incidence and number of patients who experience an AE will be reported.

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Hematology): White Blood Cell Count

Blood samples will be collected to determine the White Blood Cell Count at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Hematology): Platelet Count

Blood samples will be collected to determine the Platelet Count at designated time points up to 24 weeks.

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Hematology): Red Blood Cell Count

Blood samples will be collected to determine the Red Blood Cell Count at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Hematology): Hemoglobin

Blood samples will be collected to determine concentration of Hemoglobin at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Hematology): Hematocrit

Blood samples will be collected to determine concentration of Hematocrit at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Albumin

Data from ClinicalTrials.gov

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Blood samples will be collected to determine concentration of Albumin at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Aspartate aminotransferase (AST)

Blood samples will be collected to determine concentration of AST designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Alanine aminotransferase (ALT)

Blood samples will be collected to determine concentration of ALT designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Alkaline phosphatase (ALP)

Blood samples will be collected to determine concentration of ALP designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Total Bilirubin

Blood samples will be collected to determine concentration of Total Bilirubin at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Calcium

Blood samples will be collected to determine concentration of Calcium at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Creatinine

Blood samples will be collected to determine concentration of Creatinine at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Glucose

Blood samples will be collected to determine concentration of Glucose at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Urea

Blood samples will be collected to determine concentration of Urea at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Total Cholesterol

Blood samples will be collected to determine concentration of Total Cholesterol at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Biochemistry): High-density Lipoprotein-cholesterol (HDL-c)

Blood samples will be collected to determine concentration of HDL-c at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Low-density Lipoprotein-cholesterol (LDL-c)

Blood samples will be collected to determine concentration of LDL-c at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Chloride

Blood samples will be collected to determine concentration of Chloride at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Potassium

Blood samples will be collected to determine concentration of Potassium at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Sodium

Blood samples will be collected to determine concentration of Sodium at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Blood (occult)

Urine samples will be collected to determine the presence of Blood (occult) at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Ketones

Urine samples will be collected to determine the presence of Ketones at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Leukocyte Esterase

Urine samples will be collected to determine the presence Leukocyte Esterase of at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Nitrites

Urine samples will be collected to determine the presence of Nitrites at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Bilirubin

Urine samples will be collected to determine the presence of Bilirubin at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Glucose

Urine samples will be collected to determine the presence of Glucose at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Urobilinogen

Urine samples will be collected to determine concentration of Urobilinogen at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Protein

Urine samples will be collected to determine the presence of Protein at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Urinalysis): pH

Urine samples will be collected to determine the pH at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Specific Gravity

Urine samples will be collected to determine the Specific Gravity at designated time points up to 24 weeks

Time frame: Up to 24 weeks

Secondary Outcomes

Change from Baseline in mean pulmonary artery diastolic pressure (mPADP) at designated time points up to 24 weeks

To determine mean pulmonary artery diastolic pressure (mPADP)

Time frame: Up to 24 weeks

Change from Baseline in mean pulmonary artery pressure (mPAP) at designated time points up to 24 weeks

To determine mean pulmonary artery pressure (mPAP)

Time frame: Up to 24 weeks

Change from Baseline in mean pulmonary artery systolic pressure (mPASP) at designated time points up to 24 weeks

To determine mean pulmonary artery systolic pressure (mPASP)

Time frame: Up to 24 weeks

Change in New York Heart Association (NYHA) Class at designated time points up to 24 weeks

To determine change in New York Heart Association (NYHA) Class at Week 24

Time frame: Up to 24 weeks

Change from Baseline in number of hospitalizations or urgent outpatient visits for heart failure during the treatment period at designated time points at designated time points up to 24 weeks

To determine number of hospitalizations or urgent outpatient visits for heart failure during the treatment period

Time frame: Up to 24 weeks

Change from Baseline to Week 24 in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at designated time points up to 24 weeks

To determine N-terminal pro-B-type natriuretic peptide (NT-proBNP)

Time frame: Up to 24 weeks

Change from Baseline in 6-minute walk distance (6MWD) at designated time points up to 24 weeks

To determine 6-minute walk distance (6MWD)

Time frame: Up to 24 weeks

Change from Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CS) and Kansas City Cardiomyopathy Questionnaire-Overall Summary Score (KCCQ-OS) at designated time points up to 24 weeks

To determine change from Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CS) and Kansas City Cardiomyopathy Questionnaire-Overall Summary Score (KCCQ-OS) at Week 24.

Time frame: Up to 24 weeks