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New drug NT-88 aims to improve heart function in early trial

NCT ID NCT07509801

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called NT-88 (Zuozhu Daxi) in 60 adults with heart failure where the heart's pumping ability is mildly reduced. Participants will receive either standard heart failure drugs or standard drugs plus NT-88. The goal is to check safety and see if NT-88 can improve heart function and symptoms.

What this could mean

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

Active substance
NT-88 (Zuozhu Daxi)
What this could lead to
If it works, this could point toward a new treatment option for heart failure with mildly reduced ejection fraction.
What could go wrong
This is a very early, small study (60 people) focused on safety and preliminary effects. It may not show clear benefit or lead to a proven therapy.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

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 years and older

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: 1. Aged ≥18 years, no gender restriction; 2. Willing to participate in the study, understand and sign the informed consent form (ICF); 3. Established diagnosis of heart failure with signs and/or symptoms of heart failure; Symptoms: Dyspnea, reduced exercise tolerance, fatigue, exhaustion, etc.;Signs: Scattered moist rales in limited lung fields (clinically defined as: sparse, discontinuous, fine bubbling sounds heard in 1-2 localized lung areas during mid-to-late inspiration) or accompanied by mild cardiac murmur; Diagnostic examinations (key for confirmation): Echocardiography, natriuretic peptide testing, electrocardiography. 4. Cardiac imaging examination (primarily echocardiography) demonstrating LVEF 41%-49%; 5. New York Heart Association (NYHA) functional Class II-III (see Appendix 1); 6. Clinically stable condition with no significant changes in symptoms, signs, or treatment regimen for at least 3 months; 7. Normal cognitive function. Exclusion Criteria: 1. Known allergy to any component of the investigational product; 2. Complicated with cardiogenic shock, acute severe myocarditis, poorly controlled malignantarrhythmia, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, severevalvular disease requiring surgical intervention, or pulmonary embolism, among others; 3. Hospitalization for acute heart failure decompensation within the past 3 months; 4. Implantation of implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy(CRT) within 3 months; 5. Uncontrolled hypertension, defined as resting systolic blood pressure ≥180 mmHg and/or diastolicblood pressure ≥110 mmHg at two separate assessments prior to randomization; 6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or total bilirubin \>3 times theupper limit of normal (ULN) due to non-cardiac causes; estimated glomerular filtration rate (eGFR) \<15mL/min/1.73 m²; or serum potassium \>5.5 mmol/L; 7. Acute coronary syndrome, stroke, or transient ischemic attack within 3 months; cardiac, carotid, orother major vascular surgery; percutaneous coronary intervention (PCI), carotid angioplasty, coronary arterybypass grafting (CABG), or other cardiac surgery within 3 months; or recent onset of non-cardiac conditions affecting exercise capacity, or conditions that may be exacerbated by vigorous exercise (such as infection,hepatic or renal failure, thyrotoxicosis, etc.); 8. Major surgery within 6 months; 9. Serious primary diseases of the liver, kidney, hematopoietic system, nervous system, endocrinesystem, or other severe systemic diseases; malignancy; or psychiatric disorders; 10. Acute infection; 11. Positive for human immunodeficiency virus (HIV) antibody, positive syphilis test, or hepatitis B orhepatitis C infection; 12. Life expectancy \<1 year; 13. Known hypersensitivity to any study drug, or history of chronic urinary tract infection, or prior orplanned bariatric surgery; 14. Women who are pregnant, breastfeeding, or planning pregnancy; 15. Participation in another clinical study within 3 months; 16. Subjects deemed unsuitable for participation in this trial by the investigator.

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As listed by the trial registrant

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How to take part

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