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Clinical Trials in the USA / NCT07465653
Recruiting Phase 1

A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction

NCT07465653 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 1
Started
2026-03-18
Last updated
2026-09-10

Condition(s) studied

Heart Failure With Reduced Ejection Fraction

Investigational drug(s) / intervention(s)

HJB647 low doseHJB647 high dosePlacebo

HJB647 low dose: Study drug low dose in capsule form

HJB647 high dose: Study drug high dose in capsule form

Placebo: Placebo control in capsule form

Study summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of HJB647 at two different doses in participants with chronic stable heart failure with reduced or mildly reduced ejection fraction (HFrEF/HFmrEF).

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: Participants eligible for inclusion in this study must meet all of the following criteria: * Men and women aged 18 years or older * Stable NYHA functional class II-III * LVEF \<50% * NT-proBNP ≥600 pg/ml if in sinus rhythm or ≥900 pg/ml if in atrial fibrillation at screening * On stable standard of care therapy with sacubitril/valsartan with a dose of at least 49/51 mg BID for at least 4 weeks before screening. Exclusion Criteria: Participants will be deemed ineligible for inclusion if they meet any of the following exclusion criteria: * Acute decompensated heart failure within 3 months prior to screening * SBP \<105 mmHg at screening or baseline. * 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, or any prior valve replacement, except mitral regurgitation secondary to LV dilation at screening * eGFR \<30 ml/min/1.73m2 at screening, as measured by the CKD-EPI formula * BMI \>40 kg/m2 * Strong CYP3A4 inhibitors or inducers, sGC activators (vericiguat), PDE5 inhibitors, and nitroglycerin products * Women of childbearing potential Further eligibility criteria might apply in alignment with the trial protocol.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Synergy Healthcare Bradenton Florida Recruiting
Nature Coast Clinical Research LLC Inverness Florida Recruiting
Jacksonville Center for Clinical Jacksonville Florida Recruiting
Inpatient Research Clinical LLC Miami Lakes Florida Recruiting
Flourish Research Winter Park Florida Recruiting
Novartis Investigative Site Montreal Quebec Recruiting

More Novartis Pharmaceuticals trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07465653 on ClinicalTrials.gov ↗ ← All trials in the USA