AzTrials
AzTrials

Heart Failure With Reduced Ejection FractionPhase 2RENEU-HFNCT06369298

Study of JK07 in Patients With Chronic Heart Failure

A Phase 2 study testing JK07 in people with Heart Failure With Reduced Ejection Fraction and Heart Failure With Preserved Ejection Fraction, run by Salubris Biotherapeutics Inc at 62 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
JK07
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
282 participants
Where
62 sitesin 4 countries
Study dates
28 Mar 2024to 31 Oct 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

62 sites in 4 countries.

62 sites in 4 countries

United States51 sites

  • Site 121

    Alexander City, Alabama, 35010

  • Site 148

    Arlington, Virginia, 22205

  • Site 152

    Asheville, North Carolina, 28803

  • Site 136

    Atlanta, Georgia, 30343

  • Site 118

    Baltimore, Maryland, 21201

  • Site 130

    Birmingham, Alabama, 35211

  • Site 139

    Birmingham, Alabama, 35294

  • Site 122

    Bloomfield Hills, Michigan, 48304

  • Site 143

    Boise, Idaho, 83712

  • Site 119

    Boston, Massachusetts, 02114

  • Site 144

    Brick, New Jersey, 08724

  • Site 109

    Cary, North Carolina, 27518

  • Site 140

    Charlotte, North Carolina, 28204

  • Site 160

    Chicago, Illinois, 60611

  • Site 117

    Cincinnati, Ohio, 45219

  • Site 100

    Cleveland, Ohio, 44195

  • Site 161

    Coral Gables, Florida, 33134

  • Site 104

    Covington, Louisiana, 70433

  • Site 110

    Dallas, Texas, 75235

  • Site 115

    Dallas, Texas, 75246

  • Site 145

    Durham, North Carolina, 27710

  • Site 123

    Falls Church, Virginia, 22042

  • Site 150

    Farmington Hills, Michigan, 48334

  • Site 137

    Fort Wayne, Indiana, 46804

  • Site 114

    Hialeah, Florida, 33016

  • Site 103

    Houston, Texas, 77030

  • Site 128

    Huntington Beach, California, 92648

  • Site 138

    Huntsville, Alabama, 35801

  • Site 112

    Indianapolis, Indiana, 46250

  • Site 127

    Little Rock, Arkansas, 72205

  • Site 157

    Los Angeles, California, 90033

  • Site 162

    Miami Lakes, Florida, 33014

  • Site 159

    Naples, Florida, 34104

  • Site 126

    Norfolk, Virginia, 23507

  • Site 135

    Oklahoma City, Oklahoma, 73135

  • Site 158

    Orange, California, 92868

  • Site 154

    Park Ridge, Illinois, 60068

  • Site 116

    Pasadena, California, 91105

  • Site 111

    Phoenix, Arizona, 85016

  • Site 101

    Portland, Oregon, 97239

  • Site 107

    Rochester, Minnesota, 55905

  • Site 129

    Santa Maria, California, 93454

  • Site 106

    St Louis, Missouri, 63110

  • Site 105

    St Louis, Missouri, 63136

  • Site 102

    Stanford, California, 94305

  • Site 149

    Tomball, Texas, 77375

  • Site 113

    Torrance, California, 90502

  • Site 153

    Valhalla, New York, 10595

  • Site 163

    Vienna, Virginia, 22182

  • Site 133

    Vista, California, 92081

  • Site 155

    York, Pennsylvania, 17403

Other trials in United States

China6 sites

  • Site 300

    Beijing, 100037

  • Site 305

    Changsha, Hunan, 410005

  • Site 301

    Chengdu, Sichuan, 610041

  • Site 304

    Chongqing, 404000

  • Site 306

    Jining, Shandong, 272100

  • Site 303

    Nanjing, Jiangsu, 210009

Other trials in China

Canada4 sites

  • Site 203

    Brampton, Ontario, L6Z 4N5

  • Site 200

    Chicoutimi, Quebec, G7H 7K9

  • Site 201

    Trois-Rivières, Quebec, G9A 4P3

  • Site 202

    Winnepeg, Manitoba, R2H2A6

Other trials in Canada

Puerto Rico1 site

  • Site 156

    Ponce, 00717

Other trials in Puerto Rico

About this study

Official title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of JK07 in Adults With Chronic Heart Failure (RENEU-HF)

This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure.

There will be 2 cohorts in this study:

Cohort 1: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40%.

Cohort 2: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) > 40% and ≤ 65%.

Being tested
JK07, Placebo
Keywords
Heart Failure, Heart Failure with Reduced Ejection Fraction, Heart Failure with Preserved Ejection Fraction, Heart Failure NYHA Class III, Heart Failure NYHA Class II, Heart Failure with Atrial Fibrillation/Flutter, HFrEF, HFpEF, Neuregulin 1, NRG-1, HER3, HER4, ErbB3, ErbB4, Systolic Heart Failure, Diastolic Heart Failure, Atrial Fibrillation, Atrial Flutter
Medical subject headings
Heart Failure, Fibromatosis, Gingival, 2, Heart Failure, Systolic, Heart Failure, Diastolic, Atrial Fibrillation, Atrial Flutter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JK07Drug

    JK07 is a fully human anti-human epidermal growth factor receptor 3 (also known as ErbB3 or HER3) antibody fused with the epidermal growth factor (EGF)-domain of Neuregulin (NRG)-1b protein.

  • PlaceboDrug

    0.9% sodium chloride

Study groups in NCT06369298
Study groupRoleWhat they receive
JK07 low doseActive comparatorJK07 administered by intravenous (IV) infusion
Receives: Drug: JK07
JK07 high doseActive comparatorJK07 administered by intravenous (IV) infusion
Receives: Drug: JK07
PlaceboPlacebo comparatorPlacebo administered by intravenous (IV) infusion
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety - Cohort 1

    Incidence and severity of treatment emergent adverse events

    Measured: Study entry through week 52

  2. Efficacy - Cohort 1

    Change in LVEF measured by 2D-TTE

    Measured: Baseline through week 26

  3. Safety - Cohort 2

    Incidence and severity of treatment emergent adverse events

    Measured: Study entry through week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2024
  2. Study start28 Mar 2024
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
282 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06369298
Sponsor's protocol ID
JK07.2.01
Acronym
RENEU-HF
Status last verified
May 2026
First submitted
12 Apr 2024
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JK07 in people with Heart Failure With Reduced Ejection Fraction and Heart Failure With Preserved Ejection Fraction, run by Salubris Biotherapeutics Inc at 62 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, China, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety - Cohort 1 (time frame: Study entry through week 52). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06369298.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in