What side effects are associated with this type of intervention?

Common treatments for dyslipidemia include statins, PCSK9 inhibitors, and ezetimibe. Statins can cause muscle-related side effects such as myopathy and liver enzyme elevations. PCSK9 inhibitors, like alirocumab and evolocumab, often cause mild injection site reactions and, less frequently, hypersensitivity reactions and neurocognitive symptoms. Ezetimibe is generally well-tolerated but can cause gastrointestinal issues and, rarely, myopathy.

What prior FDA approvals exist?

The FDA has approved several lipid-lowering agents for the treatment of dyslipidemia. Statins, such as atorvastatin and rosuvastatin, are commonly used due to their efficacy in lowering LDL-C and reducing cardiovascular risk. PCSK9 inhibitors, including alirocumab and evolocumab, have also been approved and are effective in significantly lowering LDL-C levels, especially in patients with familial hypercholesterolemia. Additionally, small interfering RNA (siRNA) therapies like inclisiran have been approved for further LDL-C reduction in patients who require additional therapy beyond statins and PCSK9 inhibitors. These treatments are similar to the investigational agent LY3561774, which is being studied for its efficacy and safety in treating mixed dyslipidemia.

What other types of research exist?

Promising novel alternatives to LY3561774 for dyslipidemia patients include PCSK9 inhibitors such as inclisiran, alirocumab, and evolocumab. Inclisiran has shown significant LDL-C reduction in the ORION trials with a favorable safety profile. Alirocumab and evolocumab are fully humanized monoclonal antibodies that have demonstrated substantial LDL-C lowering and reduced rates of myocardial infarction and stroke. These agents are well-supported by clinical data and are viable options for dyslipidemia treatment in 2024.

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LY3561774 for Mixed Dyslipidemia (PROLONG-ANG3 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

Must be on a stable moderate or high-intensity dose of a statin for at least 2 months before screening and remain on the same medication and dose for the duration of the study

Be older than 18 years old

Must not have

Have a history of acute or chronic pancreatitis

Have uncontrolled hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new medication called LY3561774. It targets patients with abnormal blood fat levels who are already taking statins. The goal is to see if LY3561774 can further improve their blood fat levels.

Who is the study for?

This trial is for adults with mixed dyslipidemia who have high LDL cholesterol (≥100 mg/dL) and triglycerides (200-499 mg/dL), a BMI of 18.5 to 40 kg/m², and are on a stable statin dose. Excluded are those with recent severe cardiovascular events, heart failure, procedures affecting lipids or obesity surgery within the last year, uncontrolled hypertension or diabetes.

What is being tested?

The study tests LY3561774's effectiveness in lowering lipid levels compared to placebo in participants with mixed dyslipidemia already taking statins. It's a Phase 2b trial where patients receive either the drug or placebo through injections while their usual statin treatment continues.

What are the potential side effects?

Potential side effects of LY3561774 may include reactions at the injection site, changes in liver enzymes or fat levels that could affect organ function, muscle pain or weakness especially when combined with statins.

Eligibility Criteria

Inclusion Criteria

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

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I have been on a consistent dose of a strong statin for at least 2 months.

Exclusion Criteria

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

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I have had pancreatitis before.

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My high blood pressure is not under control.

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I have had nephrotic syndrome in the past.

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I have not had severe diabetes issues or an HbA1c ≥8% in the last 6 months.

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My heart's pumping ability is severely reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3561774 Dose 3Experimental Treatment1 Intervention

Participants will receive LY3561774 SC

Group II: LY3561774 Dose 2Experimental Treatment1 Intervention

Participants will receive LY3561774 SC

Group III: LY3561774 Dose 1Experimental Treatment1 Intervention

Participants will receive LY3561774 subcutaneously (SC)

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3561774

2020

Completed Phase 2

~280

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 dyslipidemia include statins, PCSK9 inhibitors, and other lipid-lowering agents. Statins inhibit the enzyme HMG-CoA reductase, reducing cholesterol synthesis in the liver. PCSK9 inhibitors, such as alirocumab and evolocumab, block the PCSK9 protein, increasing LDL receptors on liver cells and enhancing LDL cholesterol clearance. Ezetimibe reduces cholesterol absorption in the intestines. These treatments are vital for dyslipidemia patients as they lower LDL cholesterol levels, thereby decreasing the risk of cardiovascular events like heart attacks and strokes.