What side effects are associated with this type of intervention?

Treatments for lipoprotein disorders, particularly those aimed at reducing lipoprotein(a) levels, include PCSK9 inhibitors, statins, and ezetimibe. PCSK9 inhibitors can cause injection site reactions, nasopharyngitis, and flu-like symptoms. Statins may lead to muscle pain, liver enzyme abnormalities, and rarely, rhabdomyolysis. Ezetimibe can cause gastrointestinal issues, muscle pain, and liver enzyme elevations. These side effects are generally mild but should be monitored by a healthcare provider.

What prior FDA approvals exist?

FDA-approved treatments for lipoprotein disorders that are similar to LY3819469 include PCSK9 inhibitors like alirocumab and evolocumab. These drugs lower LDL-C and have shown efficacy in reducing lipoprotein(a) levels by inhibiting PCSK9, which enhances the clearance of LDL-C from the bloodstream. Additionally, inclisiran, a small interfering RNA, has been studied for its ability to lower PCSK9 levels and subsequently reduce both LDL-C and lipoprotein(a).

What other types of research exist?

Promising alternatives to LY3819469 for treating lipoprotein disorders include PCSK9 inhibitors like alirocumab and evolocumab, which have been shown to reduce lipoprotein(a) levels. Additionally, mipomersen, an apoB messenger RNA antisense therapy currently in phase 3 trials, may serve as a potential inhibitor of Lp(a) production.

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Monoclonal Antibodies

LY3819469 for Lipoprotein Disorder

Phase 2

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 540

Summary

This trial is testing a new drug called LY3819469 to see if it can safely lower high levels of a specific fat in the blood in adults. The goal is to reduce their risk of heart disease. Another drug, Pelacarsen, is also being reviewed for its potential to reduce heart disease risk in people with high levels of this fat.

Who is the study for?

Adults over 40 with a BMI of 18.5-40 kg/m² and high lipoprotein(a) levels (≥175 nmol/L) can join this trial. They must be on stable medication regimens if taking lipid-lowering drugs or hormones, and agree to use contraception if necessary. Those with uncontrolled diabetes, hypertension, unstable medical conditions, or any condition that could affect safety or study results are excluded.

What is being tested?

The trial is testing the effectiveness and safety of LY3819469 compared to a placebo in adults with elevated lipoprotein(a). Participants will receive either the investigational drug or a placebo for about 20 months to see how it affects their condition.

What are the potential side effects?

Specific side effects of LY3819469 aren't provided here but generally may include reactions at the injection site, potential liver issues due to changes in fat metabolism, muscle pain or weakness from statin-like effects, and possible allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 540

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 540

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 540 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3819469

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3819469 Dose 4 + PlaceboExperimental Treatment2 Interventions

Participants will receive LY3819469 SC and placebo.

Group II: LY3819469 Dose 3Experimental Treatment1 Intervention

Participants will receive LY3819469 SC.

Group III: LY3819469 Dose 2Experimental Treatment1 Intervention

Participants will receive LY3819469 SC.

Group IV: LY3819469 Dose 1Experimental Treatment1 Intervention

Participants will receive LY3819469 subcutaneously (SC).

Group V: PlaceboPlacebo Group1 Intervention

Participants will receive placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3819469

2023

Completed Phase 1

~120

Placebo

1995

Completed Phase 3

~2670

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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 lipoprotein disorders include statins, PCSK9 inhibitors, and antisense oligonucleotides. Statins work by inhibiting HMG-CoA reductase, reducing cholesterol synthesis in the liver. PCSK9 inhibitors, such as alirocumab and evolocumab, increase the number of LDL receptors on liver cells, enhancing the clearance of LDL cholesterol from the bloodstream. Antisense oligonucleotides, like those targeting apo(a), reduce the synthesis of lipoprotein(a). These mechanisms are crucial for patients with lipoprotein disorders as they help lower harmful lipid levels, reducing the risk of atherosclerotic cardiovascular disease and improving overall cardiovascular health.

Lipoprotein(a) as an Old and New Causal Risk Factor of Atherosclerotic Cardiovascular Disease.Contemporary and Novel Therapeutic Options for Hypertriglyceridemia.An overview of cholesterol management.