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Unknown

XXB750 for Heart Failure

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 91 days (cohort 1), 146 days (cohort 2)

Summary

This trial tests a new medication, XXB750, in patients with certain types of heart failure. It aims to see if the drug can improve heart function and be safely used alongside other treatments.

Who is the study for?
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.
What is being tested?
The study tests the safety and tolerability of a new medication called XXB750 compared to a placebo in patients with reduced (HFrEF) or mildly reduced (HFmrEF) ejection fraction. Participants will receive either XXB750 or placebo without knowing which one they get while researchers monitor their reactions over time.
What are the potential side effects?
While specific side effects of XXB750 aren't listed here, common side effects for drugs treating heart failure may include dizziness due to low blood pressure, changes in heartbeat rhythm, kidney problems, swelling due to fluid retention and fatigue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~91 days (cohort 1), 146 days (cohort 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 91 days (cohort 1), 146 days (cohort 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events, which may include abnormal vital signs, safety lab tests, or ECG parameters that induce clinical signs or symptoms, are considered clinically significant or require therapy
Secondary study objectives
Pharmacokinetics parameters AUCinf for Cohort 1
Pharmacokinetics parameters AUClast for Cohort 1
Pharmacokinetics parameters AUCtau for Cohort 2
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: XXB750 Cohort 2Experimental Treatment1 Intervention
XXB750, multiple doses
Group II: XXB750 Cohort 1Experimental Treatment1 Intervention
XXB750, single dose
Group III: Placebo Cohort 1Placebo Group1 Intervention
Placebo, single dose
Group IV: Placebo Cohort 2Placebo Group1 Intervention
Placebo, multiple doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XXB750
2022
Completed Phase 1
~110

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Heart Failure (HF) work through various mechanisms to improve heart function and patient outcomes. ACE inhibitors and angiotensin receptor blockers (ARBs) reduce the workload on the heart by dilating blood vessels, thereby lowering blood pressure and decreasing fluid retention. Beta-blockers slow the heart rate and reduce blood pressure, which helps to improve heart function and reduce symptoms. Diuretics help to remove excess fluid from the body, reducing the burden on the heart. Aldosterone antagonists prevent fluid retention and reduce fibrosis in the heart. Device therapies like CRT improve the coordination of heart muscle contractions, and ICDs prevent sudden cardiac death by correcting life-threatening arrhythmias. These treatments are crucial for HF patients as they help to manage symptoms, improve quality of life, and reduce the risk of hospitalization and mortality.
Growth hormone therapy in heart failure: where are we now?

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,899 Previous Clinical Trials
4,207,377 Total Patients Enrolled
68 Trials studying Heart Failure
2,001,103 Patients Enrolled for Heart Failure

Media Library

Placebo (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05328752 — Phase 1
Heart Failure Research Study Groups: XXB750 Cohort 1, Placebo Cohort 1, XXB750 Cohort 2, Placebo Cohort 2
Heart Failure Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05328752 — Phase 1
Placebo (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05328752 — Phase 1
~8 spots leftby Oct 2025