What side effects are associated with this type of intervention?

Common treatments for lipoprotein disorders, particularly those aimed at reducing Lipoprotein(a) levels, include PCSK9 inhibitors like alirocumab and evolocumab. Known side effects of these treatments are generally mild and include injection site reactions, which occur in a small percentage of patients. Other potential side effects can include flu-like symptoms, muscle pain, and elevated liver enzymes. Serious adverse reactions are rare but can include allergic reactions. These treatments have been shown to be effective in lowering LDL-C and Lipoprotein(a) levels, thereby reducing cardiovascular risk.

What prior FDA approvals exist?

The FDA has approved several treatments for lipoprotein disorders, particularly those aimed at lowering LDL-C and reducing cardiovascular risk. Notable among these are PCSK9 inhibitors such as alirocumab and evolocumab, which have been shown to effectively lower LDL-C levels and are used in patients with familial hypercholesterolemia and those at high cardiovascular risk. These treatments are relevant to the study of LY3473329, which aims to reduce Lipoprotein(a) levels to lower cardiovascular risk.

What other types of research exist?

Promising alternatives to LY3473329 for reducing Lipoprotein(a) levels and lowering cardiovascular risk include PCSK9 inhibitors such as REGN727/SAR236553 (alirocumab) and AMG145 (evolocumab). These agents have been well-tolerated and have shown potential to significantly decrease LDL-C levels when added to conventional lipid-lowering therapy. Additionally, inclisiran, another PCSK9 synthesis inhibitor, has demonstrated substantial LDL-C reductions in the ORION trials. These therapies represent novel and effective options for patients with lipoprotein disorders considering treatment in 2024.

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Antisense Oligonucleotide

LY3473329 for Lipoprotein Disorder (KRAKEN Trial)

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 week 12

Summary

This trial is testing a new drug called LY3473329. It aims to help adults who have high levels of a specific fat in their blood, known as Lp(a), which puts them at high risk for heart problems. The drug works by lowering these fat levels to reduce the risk of heart attacks and other cardiovascular events.

Who is the study for?

Adults over 40 with high levels of Lp(a) and at high risk for heart-related events can join. They must have stable health conditions, be on a consistent medication regimen for at least 4 weeks, and agree to use contraception if applicable. Those with unstable medical conditions or recent major cardiovascular events cannot participate.

What is being tested?

The trial is testing LY3473329 against a placebo to see if it's effective and safe in lowering the risk of heart problems in people with elevated Lp(a). Participants will randomly receive either the drug or a placebo while their health outcomes are monitored.

What are the potential side effects?

Possible side effects of LY3473329 aren't detailed here but typically include reactions related to the immune system, liver function changes, muscle pain, kidney issues, or bleeding disorders based on similar medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 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): Trough Concentrations (Ctrough) of LY3473329

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3473329 Dose 3Experimental Treatment1 Intervention

Participants will receive LY3473329 orally.

Group II: LY3473329 Dose 2Experimental Treatment1 Intervention

Participants will receive LY3473329 orally.

Group III: LY3473329 Dose 1Experimental Treatment1 Intervention

Participants will receive LY3473329 orally.

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive placebo orally.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3473329

2023

Completed Phase 2

~410

Do I qualify?Apply below to find out

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, particularly those targeting elevated Lipoprotein(a) [Lp(a)] and LDL-C, include statins, PCSK9 inhibitors, and emerging therapies like LY3473329. Statins work by inhibiting HMG-CoA reductase, reducing cholesterol synthesis in the liver, and increasing LDL receptor activity to lower LDL-C levels. PCSK9 inhibitors, such as alirocumab and evolocumab, prevent PCSK9 from degrading LDL receptors, thereby enhancing the clearance of LDL-C from the bloodstream. LY3473329 and similar agents aim to specifically reduce Lp(a) levels, which is crucial as elevated Lp(a) is an independent risk factor for cardiovascular events. These treatments are vital for patients with lipoprotein disorders because they help manage lipid levels, thereby reducing the risk of atherosclerotic cardiovascular disease and improving overall cardiovascular health.

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