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Completed

NCT Number: NCT06450366

A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn)

The main purpose of this study is to assess whether enlicitide is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto de Investigaciones Clínicas Mar del Plata ( Site 1002), Mar del Plata, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has either a) history of a major atherosclerotic cardiovascular disease (ASCVD) event or b) if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event
  • Has fasted lipid values (evaluated by the central laboratory) at Visit 1 (Screening) as follows: a) history of a major ASCVD event with LDL-C ≥55 mg/dL (≥1.42 mmol/L) OR b) No history of a major ASCVD event with low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL (≥1.81 mmol/L)
  • Is treated with a low, moderate, or high intensity statin (±non-statin lipid lowering therapy [LLT])
  • Is on a stable dose of all background LLTs with no planned medication or dose changes during the study
  • Is an individual of any sex/gender, from 18 years of age inclusive, at the time of providing the informed consent

Exclusion criteria

  • Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous familial hypercholesterolemia (HeFH), or double HeFH
  • Has New York Heart Association class IV heart failure, or last known left ventricular ejection fraction ≤25% by any imaging method, or had a heart failure hospitalization within 3 months before Visit 1 (Screening)
  • Participants with a history of tendon disorder or tendon rupture
  • Participants with a history of gout
  • Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening) or plans to initiate an LDL-C apheresis program
  • Was previously treated/is being treated with certain other cholesterol lowering medications, including ezetimibe, bempedoic acid, or protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout

Treatment and study plan

Enlicitide

Drug

Oral tablet

Other names: MK-0616, Enlicitide Decanoate

ezetimibe

Drug

Oral tablet

Bempedoic acid

Drug

Oral capsule

Placebo for Enlicitide

Other

enlicitide-matching placebo oral tablet

Placebo for Ezetimibe

Other

ezetimibe-matching placebo oral tablet

Placebo for Bempedoic Acid

Other

bempedoic acid-matching placebo oral capsule

Primary outcomes

  1. Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 56

    Time frame: Baseline and Day 56

    Blood samples were collected at baseline and after 56 days of treatment to assess mean percentage change in LDL-C. The mean percent change from baseline in LDL-C at Day-56 is reported.

Secondary outcomes

  1. Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 56

    Time frame: Baseline and Day 56

    Blood samples were collected at baseline and on day 56 of treatment to assess mean percent change in ApoB. The mean percent change from baseline in ApoB at Day 56 is reported.

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

    Time frame: Baseline and Day 56

    Blood samples were collected at baseline and on day 56 of treatment to assess mean percent change in non-HDL-C. The mean percent change from baseline in non-HDL-C at 56 days is reported.

  3. Median Percent Change From Baseline in Lipoprotein(a) Levels (Lp[a])

    Time frame: Baseline and Day 56

    Blood samples were collected at baseline and on day 56 of treatment to assess median percent change in Lp(a) levels. The median percent change from baseline at Day 56 is reported.

  4. Percentage of Participants Who at Day 56 Have an LDL-C <70 mg/dL and ≥50% Reduction From Baseline

    Time frame: Baseline and Day 56

    Blood samples were collected at baseline and after 56 days of treatment to assess the percentage of participants who have an LDL-C <70 mg/dL and ≥50% reduction from baseline at day 56. The percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline is reported.

  5. Percentage of Participants Who at Day 56 Have an LDL-C <55 mg/dL and ≥50% Reduction From Baseline

    Time frame: Baseline and Day 56

    Blood samples were collected at baseline and after 56 days of treatment to assess the percentage of participants who have an LDL-C <55 mg/dL and ≥50% reduction from baseline at day 56. The percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline is reported.

  6. Percentage of Participants With ≥1 Adverse Event (AE)

    Time frame: Up to approximately 147 days

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE is reported.

  7. Percentage of Participants Discontinuing From Study Intervention Due to AE

    Time frame: Up to approximately 91 days

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to an AE is reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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