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

NCT06581159 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: HS135-003
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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)

Conditions

Heart Failure With Preserved Ejection Fraction; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (31)

• 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.

  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

  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.

  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

  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

  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

  Up to 24 weeks

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

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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  Up to 24 weeks

Secondary Outcomes (8)

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

  Up to 24 weeks

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

  Up to 24 weeks

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

  Up to 24 weeks

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

  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

  Up to 24 weeks

Study Arms (2)

Investigational Product

EXPERIMENTAL

HS135 Subcutaneous Injection

Biological: HS135

Placebo

PLACEBO COMPARATOR

Subcutaneous Injection

Other: Placebo

Interventions

HS135 BIOLOGICAL

Subcutaneous Injection

Investigational Product

Placebo OTHER

Subcutaneous Injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are eligible to be included in the study only if they meet at least all the following criteria:
• Male or female, \>18 years of age.
• CardioMEMS™ Heart Failure System implanted during standard of care at least 90 days before Screening.
• Established diagnosis of HFpEF with Left Ventricular Ejection Fraction (LVEF) at least 45% as measured by echocardiography during Screening.
• New York Heart Association (NYHA) class II, III or IV heart failure symptoms.
• BMI ≥ 30 kg/m2.
• Ability to adhere to study visit schedule and understand and comply with all protocol requirements.

You may not qualify if:

• Patients will be excluded from the study if they meet any of the following criteria:
• Decompensated heart failure.
• Admission for an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 30 days prior to Screening.
• Implantation of cardiac resynchronization therapy (CRT) device within 90 days prior to Screening.
• Planned cardiovascular revascularization or major cardiac surgery or planned implantation of CRT device.
• History of heart transplant or on heart transplant list.
• Uncontrolled systemic hypertension.
• Patients who have an abnormality in echocardiography or electrocardiogram that in the opinion of the investigator increases the risk of participating in the study.
• 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.

Sponsors & Collaborators

• 35Pharma Inc: lead

Study Sites (2)

Site-104

Phoenix, Arizona, 85016, United States

Location

Site-105

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Monique Champagne, M.Sc.

  35Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind, Placebo controlled
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: September 3, 2024
• Study Start: January 23, 2025
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-07

Locations

US (2)