Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor's Decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Product | Experimental | HS135 Subcutaneous Injection |
|
| Placebo | Placebo Comparator | Subcutaneous Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS135 | Biological | Subcutaneous Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Up to 24 weeks |
| Change from Baseline in mean pulmonary artery pressure (mPAP) at designated time points up to 24 weeks |
Not provided
Inclusion Criteria:
Patients are eligible to be included in the study only if they meet at least all the following criteria:
Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Monique Champagne, M.Sc. | 35Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site-104 | Phoenix | Arizona | 85016 | United States | ||
| Site-105 |
Not provided
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Double-blind, Placebo controlled
| Placebo |
| Other |
Subcutaneous Injection |
|
| 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 |
To determine mean pulmonary artery pressure (mPAP) |
| 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) | 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 | 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 | 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) | 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) | 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. | Up to 24 weeks |
| Kansas City |
| Missouri |
| 64111 |
| United States |
| D002318 |
| Cardiovascular Diseases |