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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

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Percent Change from Baseline in LDL-C at Day 56
Secondary outcome measures
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

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
2023
Completed Phase 2
~420

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,174,683 Total Patients Enrolled
5 Trials studying High Cholesterol
14,762 Patients Enrolled for High Cholesterol
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,079,480 Total Patients Enrolled
2 Trials studying High Cholesterol
14,583 Patients Enrolled for High Cholesterol
~200 spots leftby Jul 2025
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