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New heart failure drug shows early promise in safety trial

NCT ID NCT05328752

Symptom relief Sponsor: Novartis Pharmaceuticals 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tested a new drug called XXB750 in 27 adults with stable heart failure and reduced heart pumping ability. The main goal was to see if the drug is safe and tolerable. Participants received either the drug or a placebo, and researchers monitored for side effects and how the drug moves through the body.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

27 people

The number who actually took part.

Started

May 2022

Finished

Jan 2024

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 80 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.

Key Inclusion Criteria: * NYHA functional class II-III * LVEF ≤ 50% documented at screening * Systolic blood pressure 110 - 160 mmHg (cohort 1) or 105-160 mmHg (cohort 2), and heart rate between 50-90 beats per minute, inclusive * Treatment with a stable dose of a beta blocker. * Cohort 1: Treatment with a stable dose of ACE inhibitor or ARB * Cohort 2: Treatment with a stable dose of sacubitril/valsartan. Key Exclusion Criteria * Acute decompensated heart failure within 3 months prior to screening. 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, except mitral regurgitation secondary to LV dilatation at screening * Implantation of a CRT device within 3 months prior to screening or intent to implant a CRT during the study period * History of severe pulmonary disease (e.g. COPD) requiring chronic supplemental oxygen therapy or pulmonary hypertension requiring pharmacology treatment at Screening * eGFR \<45 mL/min/1.73 m2 at screening * Cohort 1 only: Treatment with sacubitril/valsartan currently or within 4 weeks from screening * Cohort 2: Treatment with ACE inhibitor or ARB currently or within 4 weeks from screening * BMI \>40 kg/m2 Other protocol-specific criteria may apply.

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Conditions

The condition(s) this trial relates to.

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 reduced ejection fraction (hfref) Or heart failure with mildly reduced ejection fraction (hfmref)

Contacts and locations

Locations

  • Fairview Health Services .

    Saint Paul, Minnesota, 55102, United States

  • Jacksonville Ctr for Clin Rea Main Centre

    Jacksonville, Florida, 32216, United States

  • Nature Coast Clinical Research LLC

    Inverness, Florida, 34452, United States

  • Novartis Investigative Site

    Groningen, 9713 GZ, Netherlands

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