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Clinical Trials List

Protocol NumberMK-0616-017
NCT Number(ClinicalTrials.gov Identfier)NCT05952869
Completed

2023-06-20 - 2026-06-30

Phase III

Recruiting4

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 Heterozygous Familial 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 Hung-I Yeh Division of Cardiovascular Diseases
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 楊鎧鍵 Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Min-Ji Charng Division of Cardiovascular Diseases
Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

  • 陳隆景 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) The efficacy of MK-0616 compared with placebo was evaluated based on the average percentage change in low-density lipoprotein cholesterol (LDL-C) from the base period to week 24. (2) Evaluate the safety and tolerability of MK-0616. Secondary purpose: (1) Evaluate the efficacy of MK-0616 compared with placebo based on the average percentage change in LDL-C from the baseline period to week 52. (2) Evaluate the efficacy of MK-0616 compared to placebo based on the average percentage change in non-HDL-C from the baseline period to week 24. (3) Evaluate the efficacy of MK-0616 compared to placebo based on the average percentage change in apolipoprotein B (ApoB) from the base period to week 24. (4) Evaluate the efficacy of MK-0616 compared to placebo based on the average percentage change in lipoprotein a (Lp(a)) from the base period to 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 decrease of ?50% 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 and a ?50% decrease from the base period at week 24.

Test Drug

MK-0616

Active Ingredient

MK-0616

Dosage Form

Tablet

Dosage

20mg

Endpoints

(1) The efficacy of MK-0616 compared with placebo was evaluated based on the average percentage change in low-density lipoprotein cholesterol (LDL-C) from the base period to week 24.
(2) Evaluate the safety and tolerability of MK-0616.

Inclution Criteria

Inclusion Criteria:

Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm
Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history
Is treated with a moderate- or high-intensity statin medication
Is on a stable dose of all background lipid-lowering therapies (LLTs) 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

The Estimated Number of Participants

  • Taiwan

    28 participants

  • Global

    270 participants

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