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PCSK9 Inhibitor

Enlicitide Decanoate for High Cholesterol

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

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

Must have

Is on a stable dose of all background LLTs with no planned medication or dose changes during the study

Be older than 18 years old

Must not have

Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous familial hypercholesterolemia (HeFH), or double HeFH

Participants with a history of tendon disorder or tendon rupture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 112 days

Awards & highlights

Pivotal Trial

Summary

This trial aims to see if a new medication, enlicitide decanoate, is better than current treatments like ezetimibe or bempedoic acid in lowering LDL cholesterol levels in people

Who is the study for?

This trial is for adults with high cholesterol who may have had a cardiovascular event or are at risk of one. They must be on a stable dose of statins, possibly with other lipid-lowering treatments, and meet specific LDL-C levels based on their heart disease history.

What is being tested?

The study tests if Enlicitide Decanoate (an oral PCSK9 inhibitor) is better than Ezetimibe, Bempedoic Acid, or their combination in lowering 'bad' cholesterol (LDL-C). Participants will receive either the test drug or placebos to compare effects after 8 weeks.

What are the potential side effects?

While not specified here, common side effects for cholesterol medications can include muscle pain, increased blood sugar levels, nausea, liver enzyme changes, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am on a stable dose of my current medications with no changes expected.

Exclusion Criteria

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

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I have a genetic condition that causes very high cholesterol.

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I have had tendon problems or a tendon rupture in the past.

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I have a history of gout.

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I am part of, or plan to join, an LDL cholesterol cleaning program.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 112 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 112 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 112 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mean Percent Change from Baseline in LDL-C at Day 56

Secondary study objectives

Mean Percent Change from Baseline in Apolipoprotein B (ApoB) at Day 56

Mean Percent Change from Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Day 56

Number of Participants Discontinuing from Study Therapy Due to AE

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Enlicitide DecanoateExperimental Treatment3 Interventions

Participants receive enlicitide decanoate 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.

Group II: Ezetimibe + Bempedoic AcidActive Control3 Interventions

Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide decanoate-matching placebo orally QD for approximately 56 days.

Group III: EzetimibeActive Control3 Interventions

Participants receive ezetimibe 10mg, enlicitide decanoate-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.

Group IV: Bempedoic AcidActive Control3 Interventions

Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide decanoate-matching placebo QD orally up to approximately 56 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enlicitide Decanoate

2024

Completed Phase 2

~450

0 / 5Eligibility criteria met