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

Novartis Pharmaceuticals · NCT07465653

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–100 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
12
US sites recruiting
5
Study start
March 18, 2026
Record last updated
October 1, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: HJB647 low dose; HJB647 high dose; Placebo

Conditions: Heart Failure With Reduced Ejection Fraction

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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 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.

Recruiting US locations

  • Synergy Healthcare

    Bradenton, FL 34208

    Site contact: Shannon Stickels · sstickels@synergyhealthcorp.com

  • Nature Coast Clinical Research LLC

    Inverness, FL 34452

    Site contact: Jill Barnett · +1 352 341 2100 · jbarnett@flourishresearch.com

  • Jacksonville Center for Clinical

    Jacksonville, FL 32216

    Site contact: Sara Villotti · +1 904 730 0101 · svillotti@flourishresearch.com

  • Inpatient Research Clinical LLC

    Miami Lakes, FL 33014

    Site contact: Lazaro Rivero · +1 786 502 4303 · lrivero@inpatientresearch.com

  • Flourish Research

    Winter Park, FL 32789

    Site contact: Sara Contreras · scontreras@flourishresearch.com

Study contacts (from the official record)

  • Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
  • Novartis Pharmaceuticals · +41613241111
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