Clinical trial NCT06581159: Study of HS135 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
Official title: Phase 1b Double-Blind, Placebo-Controlled, MAD 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
Overall status: RECRUITING
Phase: PHASE1
Conditions: Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension
Lead sponsor: 35Pharma Inc
Sponsor class: INDUSTRY
First posted: 2024-09-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Detailed 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

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. 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.

Primary outcomes:
measure: Incidence and Number of Adverse Events (AEs)
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Hematology): White Blood Cell Count
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Hematology): Platelet Count
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Hematology): Red Blood Cell Count
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Hematology): Hemoglobin
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Hematology): Hematocrit
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Albumin
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Aspartate aminotransferase (AST)
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Alanine aminotransferase (ALT)
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Alkaline phosphatase (ALP)
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Total Bilirubin
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Calcium
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Creatinine
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Glucose
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Urea
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Total Cholesterol
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Biochemistry): High-density Lipoprotein-cholesterol (HDL-c)
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Low-density Lipoprotein-cholesterol (LDL-c)
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Chloride
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Potassium
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Sodium
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Blood (occult)
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Ketones
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Leukocyte Esterase
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Nitrites
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Bilirubin
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Glucose
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Urobilinogen
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Protein
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Urinalysis): pH
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Specific Gravity
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Change from Baseline in mean pulmonary artery diastolic pressure (mPADP) at designated time points up to 24 weeks
timeFrame: Up to 24 weeks
measure: Change from Baseline in mean pulmonary artery pressure (mPAP) at designated time points up to 24 weeks
timeFrame: Up to 24 weeks
measure: Change from Baseline in mean pulmonary artery systolic pressure (mPASP) at designated time points up to 24 weeks
timeFrame: Up to 24 weeks
measure: Change in New York Heart Association (NYHA) Class at designated time points up to 24 weeks
timeFrame: Up to 24 weeks
measure: 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
timeFrame: Up to 24 weeks
measure: Change from Baseline to Week 24 in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at designated time points up to 24 weeks
timeFrame: Up to 24 weeks
measure: Change from Baseline in 6-minute walk distance (6MWD) at designated time points up to 24 weeks
timeFrame: Up to 24 weeks
measure: 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
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site-104
state: Arizona
city: Kansas City
country: United States
facility: Site-105
state: Missouri
Study officials:
affiliation: 35Pharma Inc
name: Monique Champagne, M.Sc.
role: STUDY_DIRECTOR
References: