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Clinical Trials List

Protocol NumberMK-0616-019
NCT Number(ClinicalTrials.gov Identfier)NCT06492291
Active

2024-05-01 - 2029-12-31

Phase III

Recruiting10

ICD-10E78.0

Pure hypercholesterolemia

ICD-9272.0

Pure hypercholesterolemia

A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/24

Investigators and Locations

Principal Investigator 施志遠 Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 夏建勳 Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-I Yeh Division of Cardiovascular Diseases

Co-Principal Investigator

  • 李應湘 Division of Cardiovascular Diseases
  • 洪崇烈 Division of Cardiovascular Diseases
  • 程崇偉 Division of Cardiovascular Diseases
  • 簡禎彥 Division of Cardiovascular Surgery
  • 李俊偉 Division of Cardiovascular Diseases
  • 洪大川 Division of Cardiovascular Diseases
  • 陳律安 Division of Neurology
  • 劉俊傑 Division of Cardiovascular Diseases
  • 林書毅 Division of Cardiovascular Diseases
  • 郭任遠 Division of Cardiovascular Diseases
  • 蘇正煌 Division of Cardiovascular Diseases
  • 吳懿哲 Division of Cardiovascular Diseases
  • 林肇鋒 Division of Cardiovascular Diseases
  • 陳俊延 Division of Cardiovascular Diseases
  • 廖峰慶 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Min-Ji Charng Division of Cardiovascular Diseases

Co-Principal Investigator

  • 陳隆景 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Yao Huang Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 楊鎧鍵 Division of General Internal Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鄭正一 Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Po-Hsun Huang Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 洪國竣 Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ping-Yen Liu

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Hypercholesterolemia

Objectives

Testing the long-term safety of MK-0616; observing the cholesterol-lowering efficacy of MK-0616 over time.

Test Drug

錠劑

Active Ingredient

MK-0616

Dosage Form

110

Dosage

20 mg

Endpoints

Adverse events (AEs), discontinuation of trial treatment due to AEs

Inclution Criteria

Inclusion Criteria:

Has completed an enlicitide decanoate (also known as enlictide and MK-0616) parent study [MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT06450366)] per protocol (including the final assessments/procedures of their parent study)
Had an overall study intervention compliance ≥80% while participating in their parent study

Exclusion Criteria

Exclusion Criteria:

Has discontinued study intervention in their parent study
Has an ongoing serious adverse event considered related to study intervention by the investigator in the parent study
Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study
Is currently participating in an interventional clinical study other than an enlicitide decanoate parent study

The Estimated Number of Participants

  • Taiwan

    250 participants

  • Global

    3000 participants