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Clinical Trials List

Protocol NumberMK-0616-019
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

    Merck Sharp & Dohme LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

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 夏建勳 Division of Cardiovascular Diseases
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-I Yeh Division of Cardiovascular Diseases
MacKay Memorial Hospital

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
  • 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
  • 林書毅 Division of Cardiovascular Diseases
  • 郭任遠 Division of Cardiovascular Diseases
  • 蘇正煌 Division of Cardiovascular Diseases
  • 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

The Actual Total Number of Participants Enrolled

0 Recruiting

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 洪國竣 Division of Cardiovascular Diseases
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Yao Huang
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Hypercholesterolemia

Objectives

To evaluate the safety and tolerability of enlicitide treatment

Test Drug

tablet

Active Ingredient

MK-0616

Dosage Form

110

Dosage

20 mg

Endpoints

AEs
Discontinuation of study intervention due to
AEs

Inclution Criteria

An individual is eligible for inclusion in the study if the individual meets all of the following
criteria:
Type of Participant and Disease Characteristics
1. Has completed an MK-0616 (enlicitide) parent study (P013, P017, P018) per protocol
(including the final assessments/procedures of their parent study [ie, Visit 8 in P013 and
P017, and Visit 6 in P018]). Refer to Appendix 7 for country-specific requirements.
2. Had overall study intervention compliance ≥80% while participating in their parent study
(excluding time off study intervention related to AEs and protocol-specified
interruptions).
Demographics
3. Is an individual of any sex/gender, from 18 years of age inclusive, at the time of
providing the informed consent.
Female Participants
4. A participant assigned female sex at birth is eligible to participate if not pregnant or
breastfeeding, and at least one of the following conditions applies:
• Is not a POCBP
OR
• Is a POCBP and:
 Uses an acceptable contraceptive method, or is abstinent from penile-vaginal
intercourse as their preferred and usual lifestyle (abstinent on a long-term and
persistent basis), as described in Appendix 5 during the intervention period and for at
least 56 days after the last dose of study intervention. The investigator should
evaluate the potential for contraceptive method failure (ie, noncompliance, recently
initiated) in relationship to the first dose of study intervention. Contraceptive use by
POCBPs should be consistent with local regulations regarding the methods of
contraception for those participating in clinical studies. If the contraception
requirements in the local label for any of the study interventions are more stringent
than the requirements above, the local label requirements are to be followed.

Exclusion Criteria

An individual must be excluded from the study if the individual meets any of the following
criteria:
1. Has discontinued study intervention in their parent study.
Medical Conditions
2. At Visit 1, has developed a clinically significant malabsorption condition (eg, recurrent
vomiting, inflammatory bowel disease with ongoing symptoms, chronic intestinal disease
accompanied by a disturbance in digestion and absorption, or a history of extensive
resection of the upper GI tract) or new/active liver disease, based on principal
investigator assessment.
3. At Visit 1, has an ongoing SAE considered related to study intervention by the
investigator in the parent study.
Prior/Concomitant Therapy
4. Is planning to begin treatment with a nonstudy PCSK9i (siRNA or mAb) while enrolled
in the study.
Prior/Concurrent Clinical Study Experience
5. Is currently participating in an interventional clinical study other than an
MK-0616 (enlicitide) parent study (ie, P013, P017, P018).

The Estimated Number of Participants

  • Taiwan

    250 participants

  • Global

    3000 participants

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