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New heart failure drug JK07 enters Mid-Stage trial

NCT ID NCT06369298

Disease control Sponsor: Salubris Biotherapeutics Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests JK07, a lab-made protein designed to help heart cells repair and pump better. About 282 adults with chronic heart failure will receive either JK07 or a placebo. The study looks at safety and whether JK07 can improve heart function in two groups: those with very weak hearts and those with moderately weak hearts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JK07 (a lab-made protein that targets HER3 and delivers a growth factor signal to heart cells)
What this could lead to
If it works, JK07 could offer a new way to improve heart pumping strength and manage symptoms in people with chronic heart failure.
What could go wrong
This is a mid-stage trial with 282 participants, so results are not yet proven. The drug may cause side effects or fail to show meaningful benefit over placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 282 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants with New York Heart Association (NYHA) Class II-III. * Cohort 1 - Left Ventricular Ejection Fraction (LVEF) ≤ 40%. * Cohort 2 - Left Ventricular Ejection Fraction (LVEF) \>40% and ≤ 65%, elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥ 600pg/mL and atrial fibrillation/flutter. * Stable heart failure and on optimal medical therapy. * Screening hemoglobin ≥ 9.0 g/dL. Exclusion Criteria: * Uncontrolled hypertension. * Sustained systolic Blood Pressure (BP) \< 90 mmHg and/or diastolic BP \< 50 mmHg on 2 consecutive (duplicate seated) readings at screening. * Heart failure due to hypertrophic cardiomyopathy, restrictive and/or infiltrative cardiomyopathy, arrhythmogenic right ventricular dysplasia, Fabry disease, or Noonan syndrome with LV hypertrophy or a positive serum immunofixation result. * Diagnosis of stress-induced (Takotsubo) cardiomyopathy, myocarditis, or peripartum cardiomyopathy. * Diagnosis of chemotherapy- or radiation-induced cardiomyopathy. * Diagnosed with stroke or Transient Ischemic Attack (TIA) within 12 weeks of screening. * History of syncope within the last 12 weeks prior to screening or sustained ventricular tachycardia without an implantable cardioverter-defibrillator. * Moderate or severe aortic and/or mitral valve stenosis. * Medically documented unstable angina, acute coronary syndrome (e.g., myocardial infarction, troponin-positive with symptoms of angina or unstable angina) within the last 8 weeks prior to start of screening. * Medically documented ST-elevation myocardial infarction within 12 weeks of screening. * Any tachycardia (inclusive of Atrial Fibrillation (AF) or atrial flutter) with a resting ventricular rate \> 110 beats per minute at screening. * For participants with a history of AF or atrial flutter, not on adequate anticoagulant therapy via non-vitamin K oral anticoagulants or warfarin if the CHA2DS2-VASc score is ≥ 2 in men or ≥ 3 in women or per local guidelines. Percutaneous occlusion of the left atrial appendage alone is not adequate. * AF ablation within the last 12 weeks prior to screening or planned during the study duration. * Symptomatic bradycardia or second (Mobitz Type II)- or third-degree heart block without a pacemaker. * Cardiac surgery, coronary artery revascularization or indication for coronary artery revascularization, percutaneous coronary intervention, valve repair/replacement or valvuloplasty within 12 weeks prior to screening. * Implantation of a Cardiac Resynchronization Therapy (CRT) device within 12 weeks prior to screening, or intent to implant a CRT device during the course of the study. * Previous cardiac transplantation, or any use of mechanical circulatory support or similar device, or implantation expected after randomization. * Receiving mechanical hemodynamic support or invasive mechanical ventilation within the last 8 weeks prior to screening. * Receiving Intravenous (IV) inotropes or IV vasopressors within the last 8 weeks prior to screening. * Receiving IV vasodilators within the last 4 weeks prior to screening. * Receiving noninvasive mechanical ventilation within the last 4 weeks prior to screening. The use of noninvasive ventilation for sleep disordered breathing is permitted.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation atrial flutter diastolic heart failure fibromatosis, gingival, 2 heart failure systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure with preserved ejection fraction Heart failure with reduced ejection fraction

Contacts and locations

Locations

  • Site 100

    Cleveland, Ohio, 44195, United States

  • Site 101

    Portland, Oregon, 97239, United States

  • Site 102

    Stanford, California, 94305, United States

  • Site 103

    Houston, Texas, 77030, United States

  • Site 104

    Covington, Louisiana, 70433, United States

  • Site 105

    St Louis, Missouri, 63136, United States

  • Site 106

    St Louis, Missouri, 63110, United States

  • Site 107

    Rochester, Minnesota, 55905, United States

  • Site 109

    Cary, North Carolina, 27518, United States

  • Site 110

    Dallas, Texas, 75235, United States

  • Site 111

    Phoenix, Arizona, 85016, United States

  • Site 112

    Indianapolis, Indiana, 46250, United States

  • Site 113

    Torrance, California, 90502, United States

  • Site 114

    Hialeah, Florida, 33016, United States

  • Site 115

    Dallas, Texas, 75246, United States

  • Site 116

    Pasadena, California, 91105, United States

  • Site 117

    Cincinnati, Ohio, 45219, United States

  • Site 118

    Baltimore, Maryland, 21201, United States

  • Site 119

    Boston, Massachusetts, 02114, United States

  • Site 121

    Alexander City, Alabama, 35010, United States

  • Site 122

    Bloomfield Hills, Michigan, 48304, United States

  • Site 123

    Falls Church, Virginia, 22042, United States

  • Site 126

    Norfolk, Virginia, 23507, United States

  • Site 127

    Little Rock, Arkansas, 72205, United States

  • Site 128

    Huntington Beach, California, 92648, United States

  • Site 129

    Santa Maria, California, 93454, United States

  • Site 130

    Birmingham, Alabama, 35211, United States

  • Site 133

    Vista, California, 92081, United States

  • Site 135

    Oklahoma City, Oklahoma, 73135, United States

  • Site 136

    Atlanta, Georgia, 30343, United States

  • Site 137

    Fort Wayne, Indiana, 46804, United States

  • Site 138

    Huntsville, Alabama, 35801, United States

  • Site 139

    Birmingham, Alabama, 35294, United States

  • Site 140

    Charlotte, North Carolina, 28204, United States

  • Site 143

    Boise, Idaho, 83712, United States

  • Site 144

    Brick, New Jersey, 08724, United States

  • Site 145

    Durham, North Carolina, 27710, United States

  • Site 148

    Arlington, Virginia, 22205, United States

  • Site 149

    Tomball, Texas, 77375, United States

  • Site 150

    Farmington Hills, Michigan, 48334, United States

  • Site 152

    Asheville, North Carolina, 28803, United States

  • Site 153

    Valhalla, New York, 10595, United States

  • Site 154

    Park Ridge, Illinois, 60068, United States

  • Site 155

    York, Pennsylvania, 17403, United States

  • Site 156

    Ponce, 00717, Puerto Rico

  • Site 157

    Los Angeles, California, 90033, United States

  • Site 158

    Orange, California, 92868, United States

  • Site 159

    Naples, Florida, 34104, United States

  • Site 160

    Chicago, Illinois, 60611, United States

  • Site 161

    Coral Gables, Florida, 33134, United States

  • Site 162

    Miami Lakes, Florida, 33014, United States

  • Site 163

    Vienna, Virginia, 22182, United States

  • Site 200

    Chicoutimi, Quebec, G7H 7K9, Canada

  • Site 201

    Trois-Rivières, Quebec, G9A 4P3, Canada

  • Site 202

    Winnepeg, Manitoba, R2H2A6, Canada

  • Site 203

    Brampton, Ontario, L6Z 4N5, Canada

  • Site 300

    Beijing, 100037, China

  • Site 301

    Chengdu, Sichuan, 610041, China

  • Site 303

    Nanjing, Jiangsu, 210009, China

  • Site 304

    Chongqing, 404000, China

  • Site 305

    Changsha, Hunan, 410005, China

  • Site 306

    Jining, Shandong, 272100, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.