Study of HS135 in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction
NCT Number: NCT06581159
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Heart Failure with Preserved Ejection Fraction|Pulmonary Hypertension
Sponsor: 35Pharma Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-06

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

Primary Outcome Measures: 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