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

A Randomized, Participant and Investigator Blinded, Sponsor Open-label, Placebo-controlled, Single Dose Study to Investigate the Safety and Tolerability of XXB750 in Heart Failure Participants With Reduced Ejection Fraction (HFrEF)

ClinicalTrials.gov Identifier: NCT05328752

Novartis Reference Number: CXXB750A12101

Last Update: Jul 28, 2022

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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. 

Study Description

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.

Condition 
Heart Failure With Reduced Ejection Fraction (HFrEF)
Phase 
Phase 1
Overall status 
Recruiting
Start date 
May 17, 2022
Completion date 
Jun 13, 2023
Gender 
All
Age(s)
18 Years - 78 Years (Adult, Older Adult)

Interventions

Drug
XXB750
XXB750
Drug
Placebo
Placebo

Eligibility Criteria

Key Inclusion Criteria:

NYHA functional class II-III
LVEF ≤ 45% documented at screening
Systolic blood pressure 110 - 180 mmHg (cohort 1) or 105-180 mmHg (cohort 2), and heart rate ≤90 beats per minute
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 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
Cohort 1 only: Treatment with sacubitril/valsartan currently or within 2 weeks from screening
Cohort 2: Treatment with ACE inhibitor or ARB currently or within 4 weeks from screening
BMI >35 kg/m2

Other protocol-specific criteria may apply.

Study Locations

United States
Novartis Investigative Site
Recruiting
Jacksonville, 32216
Florida
United States
Novartis Investigative Site
Recruiting
Saint Paul, 55102
Minnesota
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]