What side effects are associated with this type of intervention?

Common treatments for heart failure, particularly those similar to LY3461767, include beta-blockers, ACE inhibitors, ARBs, and diuretics. These medications can cause side effects such as hypotension, dizziness, renal impairment, hyperkalemia, and electrolyte imbalances. Continuous subcutaneous infusions, like those used in the LY3461767 study, may also lead to local site reactions such as pain, erythema, and bruising.

What prior FDA approvals exist?

Several FDA-approved treatments for heart failure, particularly for HFrEF, include medications like sacubitril/valsartan (Entresto), which is an angiotensin receptor-neprilysin inhibitor (ARNI), and ivabradine (Corlanor), which reduces heart rate. Additionally, traditional treatments include beta-blockers (e.g., carvedilol), ACE inhibitors (e.g., enalapril), and mineralocorticoid receptor antagonists (e.g., spironolactone). While LY3461767 is being studied for continuous subcutaneous infusion, other infusion-based treatments like inotropes (e.g., dobutamine) are used in acute settings for severe heart failure. These treatments aim to improve heart function, reduce symptoms, and enhance quality of life in heart failure patients.

What other types of research exist?

Promising novel alternatives to LY3461767 for HFrEF patients include SGLT2 inhibitors like dapagliflozin and empagliflozin, which have shown significant benefits in reducing cardiovascular death and hospitalization. Additionally, vericiguat, a soluble guanylate cyclase stimulator, has been approved for HFrEF patients to reduce the risk of cardiovascular death and heart failure hospitalization. These treatments have demonstrated efficacy and safety in clinical trials and are considered effective options for managing HFrEF.

← Back to Search

Other

LY3461767 for Heart Failure

Phase 1

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not changed optimal guideline directed therapy in the last 1 month prior to screening

Males in agreement to follow contraceptive requirements, or women of non-child-bearing potential

Must not have

Cardiac amyloidosis, accumulation diseases (e.g., haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic cardiomyopathy, pericardial constriction, or complex congenital heart disease

History of malignancy or active malignancy at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through day 90

Summary

This trial tests a new drug, LY3461767, for safety in people with a specific type of heart failure. The drug is given through a small tube under the skin for a few days. The study checks how the drug affects patients and how their bodies handle it.

Who is the study for?

This trial is for men willing to follow contraceptive guidelines or women not of childbearing potential, with chronic heart failure (NYHA II/III) and a left ventricular ejection fraction under 40%. Participants must have stable heart failure medication doses and meet specific blood test criteria. Exclusions include recent major cardiovascular events, certain valve diseases, liver/biliary disorders, lack of cancer screening, and some other cardiac conditions.

What is being tested?

The study tests the safety and tolerability of LY3461767 in patients with chronic heart failure with reduced ejection fraction (HFrEF). It involves continuous subcutaneous infusion over several days. The drug's levels in the blood will be monitored to see how quickly it's eliminated from the body.

What are the potential side effects?

While specific side effects are not listed here, participants will be closely monitored for any adverse reactions related to LY3461767 during its continuous infusion treatment for heart failure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I haven't changed my cancer treatment plan in the last month.

Select...

I agree to use contraception or am not able to have children.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a heart condition like amyloidosis or muscular dystrophy.

Select...

I have a history of cancer or currently have cancer.

Select...

I have moderate-to-severe narrowing or leakage in my heart valves.

Select...

I have had liver, pancreas, or bile duct problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Secondary study objectives

PK: Maximum Concentration (Cmax) of LY3461767

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3461767

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3461767Experimental Treatment1 Intervention

LY3461767 administered subcutaneously (SC).

Group II: PlaceboPlacebo Group1 Intervention

Placebo administered subcutaneously (SC).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3461767

2021

Completed Phase 1

~50

0 / 6Eligibility criteria met

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 with Reduced Ejection Fraction (HFrEF) include ACE inhibitors, which reduce blood pressure and decrease the heart's workload by blocking the conversion of angiotensin I to angiotensin II. Beta-blockers slow the heart rate and reduce blood pressure, improving heart function over time. Diuretics help eliminate excess fluid, reducing symptoms like swelling and shortness of breath. Neprilysin inhibitors, often combined with angiotensin receptor blockers (ARNIs), enhance the effects of natriuretic peptides, leading to vasodilation and reduced fluid overload. SGLT2 inhibitors, initially used for diabetes, have shown benefits in heart failure by reducing hospitalization rates and improving cardiovascular outcomes. Investigational drugs like LY3461767 are being studied to further improve safety and tolerability in HFrEF patients. These treatments are crucial as they help manage symptoms, improve quality of life, and reduce mortality in heart failure patients.

The disconnect between phase II and phase III trials of drugs for heart failure.