Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced Ejection Fraction (HFrEF)

• Status: Not yet recruiting
• Trial end date: 2022-10-21
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, randomized, sponsor open-label, participant and investigator blinded, placebo-controlled, single dose study to investigate the safety and tolerability of a single subcutaneous dose of XXB750 in HFrEF.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Key Inclusion Criteria:

• NYHA functional class II-III

• LVEF ≤ 45% documented at screening

• Systolic blood pressure 110 - 180 mmHg and heart rate ≤90 beats per minute Key Exclusion Criteria

• Acute heart failure, 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

• Treatment with Sacubitril/Valsartan currently or within 2 weeks from screening

• BMI >35 kg/m2

Other protocol-specific criteria may apply.