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A Study of the Efficacy and Safety of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 2

Conditions

Hypercholesterolemia
Familial Hypercholesterolemia

Treatments

Drug: MK-0616
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05261126
jRCT2031210701 (Registry Identifier)
MK-0616-008 (Other Identifier)
2021-005221-24 (EudraCT Number)
0616-008

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of MK-0616, an oral PCSK9 inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia. The primary hypothesis is that at least one of the four doses of MK-0616 tested in this study is superior to placebo on percent change from baseline in LDL-C at Week 8.

Enrollment

381 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • History of clinical atherosclerotic cardiovascular disease (ASCVD), or has an ASCVD risk equivalent and/or a 10-year risk of having an ASCVD event ≥5.0%, AND has a corresponding LDL-C that falls within the protocol-specified range at screening.
  • Treatment with a stable dose of one or more lipid-lowering therapies for ≥30 days before screening, or has not received treatment with any lipid-lowering therapy for ≥30 days before screening.
  • A female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and for at least 8 weeks after the last dose of study intervention.

Exclusion criteria

  • History of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria.
  • History of nephrotic syndrome.
  • History of unstable angina, a myocardial infarction, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening.
  • Has poorly controlled diabetes mellitus, defined as hemoglobin A1C (A1C) ≥9.0% at Screening.
  • History of malignancy ≤3 years before screening, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, which have no timeframe limitations relative to screening.
  • Currently participating in or has previously participated in an interventional clinical study within 3 months before Screening.
  • Has moderate or greater renal insufficiency.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

381 participants in 5 patient groups, including a placebo group

MK-0616 6 mg
Experimental group
Description:
Participants will receive 6 mg of MK-0616 orally QD for 8 weeks
Treatment:
Drug: MK-0616
MK-0616 12 mg
Experimental group
Description:
Participants will receive 12 mg of MK-0616 orally QD for 8 weeks
Treatment:
Drug: MK-0616
MK-0616 18 mg
Experimental group
Description:
Participants will receive 18 mg of MK-0616 orally QD for 8 weeks
Treatment:
Drug: MK-0616
MK-0616 30 mg
Experimental group
Description:
Participants will receive 30 mg of MK-0616 orally QD for 8 weeks
Treatment:
Drug: MK-0616
Placebo
Placebo Comparator group
Description:
Participants will receive MK-0616-matching placebo orally QD for 8 weeks
Treatment:
Drug: Placebo

Trial documents
1

Trial contacts and locations

63

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Data sourced from clinicaltrials.gov

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