Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF)
A Randomized, Participant- and Investigator-blinded, Sponsor Open-label, Placebo-controlled, Single and Multiple Dose Study to Investigate the Safety and Tolerability of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF)
ClinicalTrials.gov Identifier: NCT05328752
Novartis Reference Number: CXXB750A12101
Last Update: Feb 10, 2023
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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.
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.