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Clinical Trials List

Protocol NumberMK-0616-013
NCT Number(ClinicalTrials.gov Identfier)NCT05952856
Completed

2023-07-01 - 2026-01-31

Phase III

Recruiting7

ICD-10E78.0

Pure hypercholesterolemia

ICD-9272.0

Pure hypercholesterolemia

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chun-Yao Huang Division of Cardiovascular Diseases
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 楊鎧鍵 Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 夏建勳 Division of Cardiovascular Diseases
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鄭正一 Division of Cardiovascular Diseases
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 施志遠 Division of Cardiovascular Diseases
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Po-Hsun Huang Division of Cardiovascular Diseases
Taipei Veterans General Hospital

Co-Principal Investigator

  • 黃金洲 Division of Cardiovascular Diseases
  • 張俊欽 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ting-Hsing Chao Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Hypercholesterolemia、 Familial Hypercholesterolemia

Objectives

main purpose: (1) Evaluate the efficacy of MK-0616 compared to placebo in terms of the average percentage change in low-density lipoprotein cholesterol (LDL-C) from the base period at week 24 (2) Evaluate the safety and tolerability of MK-0616 Secondary purpose: (1) Evaluate the efficacy of MK-0616 compared to placebo in terms of the average percentage change in LDL-C from the base period at week 52 (2) Evaluate the efficacy of MK-0616 compared to placebo in terms of the average percentage change from the base period in non-HDL-C at week 24 (3) Evaluate the efficacy of MK-0616 compared to placebo in terms of the average percentage change in lipoprotein B (ApoB) from the base period at week 24 (4) Evaluate the efficacy of MK-0616 compared to placebo in terms of the average percentage change in lipoprotein a (Lp(a)) from the base period at week 24 (5) Evaluate the efficacy of MK-0616 compared with placebo in terms of the proportion of subjects with LDL-C <70 mg/dL at week 24 and a 50% decrease from the base period (6) Evaluate the efficacy of MK-0616 compared with placebo in terms of the proportion of subjects with LDL-C <55 mg/dL at week 24 and a 50% decrease from the base period

Test Drug

MK-0616

Active Ingredient

MK-0616

Dosage Form

Tablet

Dosage

20 mg

Endpoints

LDL-C
adverse events
Discontinuation of trial treatment due to adverse events
Non-HDL-C
ApoB
Lp(a)

Inclution Criteria

Inclusion Criteria:

Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C ≥70 mg/dL.
Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance
If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change.

Exclusion Criteria

Exclusion Criteria:

Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
Has a history of heart failure or heart failure hospitalization within 3 months before first study visit
Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program
Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout

The Estimated Number of Participants

  • Taiwan

    165 participants

  • Global

    2760 participants

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