Heart Failure Clinical Trial
Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF)
Summary
This is a multi-center, randomized, sponsor open-label, participant- and investigator-blinded, placebo-controlled, single and multiple dose study to investigate the safety and tolerability of XXB750 in HFrEF/HFmrEF.
Full Description
This is a multi-center, randomized, sponsor open-label, participant- and investigator-blinded, placebo-controlled, single and multiple dose study to investigate the safety and tolerability of XXB750 in participants with HFrEF/HFmrEF. A screening period of up to 29 days will be used to assess participants' eligibility. Participants will be randomized into one of two cohorts based on background therapy. Participants will be randomized in a 2:1 ratio (Cohort 1) or 3:1 ratio (Cohort 2). In Cohort 1, participants will receive a single dose of either subcutaneous (s.c.) XXB750 or placebo. In Cohort 2, participants will receive three doses of either s.c. XXB750 or placebo.
Eligibility Criteria
Key Inclusion Criteria:
NYHA functional class II-III
LVEF ≤ 50% documented at screening
Systolic blood pressure 110 - 160 mmHg (cohort 1) or 105-160 mmHg (cohort 2), and heart rate between 50-90 beats per minute, inclusive
Treatment with a stable dose of a beta blocker.
Cohort 1: Treatment with a stable dose of ACE inhibitor or ARB
Cohort 2: Treatment with a stable dose of sacubitril/valsartan.
Key Exclusion Criteria
Acute decompensated heart failure within 3 months prior to screening. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid, or other major cardiovascular surgery, PCI, or carotid angioplasty within the 6 months prior to screening
Hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to LV dilatation at screening
Implantation of a CRT device within 3 months prior to screening or intent to implant a CRT during the study period
History of severe pulmonary disease (e.g. COPD) requiring chronic supplemental oxygen therapy or pulmonary hypertension requiring pharmacology treatment at Screening
eGFR <45 mL/min/1.73 m2 at screening
Cohort 1 only: Treatment with sacubitril/valsartan currently or within 4 weeks from screening
Cohort 2: Treatment with ACE inhibitor or ARB currently or within 4 weeks from screening
BMI >40 kg/m2
Other protocol-specific criteria may apply.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 6 Locations for this study
Inverness Florida, 34452, United States
Jacksonville Florida, 32216, United States
Saint Paul Minnesota, 55102, United States
New York New York, 10019, United States
Chapel Hill North Carolina, 27514, United States
Groningen , 9713 , Netherlands
How clear is this clinincal trial information?