XXB750 for Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called XXB750 to determine its safety and tolerability for people with certain types of heart failure. The study includes two groups: one will receive a single dose, and the other will receive multiple doses of XXB750, with some participants receiving a placebo for comparison. It seeks participants who have been living with heart failure that affects their daily life, have had it for a while, and are already on stable heart medications. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires participants to be on a stable dose of certain medications. If you are in Cohort 1, you must be on a stable dose of a beta blocker and an ACE inhibitor or ARB. If you are in Cohort 2, you must be on a stable dose of a beta blocker and sacubitril/valsartan. You may need to stop taking sacubitril/valsartan if you are in Cohort 1 or ACE inhibitor/ARB if you are in Cohort 2, at least 4 weeks before screening.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that XXB750 has been tested for safety in people with heart failure. Previous studies found it generally well-tolerated. Some research examined different doses of XXB750 and found no severe side effects. However, like many treatments, some people might still experience mild reactions.
XXB750 is currently being tested for heart failure, but this is an early trial. The goal is to assess its safety and tolerability. While past trials provide promising data, more research is needed to fully understand its safety.12345Why do researchers think this study treatment might be promising for heart failure?
Unlike the standard treatments for heart failure, which often focus on easing symptoms or slowing progression, XXB750 is unique because it directly targets the underlying mechanisms of the condition. Researchers are particularly excited about XXB750 because it introduces a new active ingredient that could potentially improve heart function more effectively. Additionally, the treatment comes in two forms—single and multiple doses—offering flexibility that might lead to more personalized care for patients. This novel approach could represent a significant advancement in how we manage heart failure, potentially leading to better patient outcomes.
What evidence suggests that XXB750 might be an effective treatment for heart failure?
Research has shown that XXB750 might help people with heart failure who have a lower or slightly lower heart pumping ability. In some studies, patients taking XXB750 have exercised longer and felt better. Another study found that XXB750 lowered levels of NT-proBNP, a substance often high in people with heart failure, suggesting that the treatment could improve heart function. Although the research remains in the early stages, these initial results are promising for those considering this treatment. Participants in this trial will receive either XXB750 or a placebo, with some receiving a single dose and others multiple doses, to further evaluate its effectiveness.13678
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults with heart failure who have a left ventricular ejection fraction (LVEF) of 50% or less. They must have stable blood pressure and heart rate, be on certain heart medications, and not severely overweight. Excluded are those with severe lung disease, recent acute heart failure or cardiovascular events, significant valve disease, recent device implantation in the heart, or poor kidney function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Cohort 1 receives a single dose of XXB750 or placebo, followed by a domiciling period. Cohort 2 receives three doses of XXB750 or placebo, each followed by a domiciling period.
Follow-up
Participants are monitored for safety, tolerability, and pharmacokinetics after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- XXB750
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD