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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia; Familial Hypercholesterolemia

Treatments: Drug: Enlicitide Decanoate; 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 enlicitide decanoate, 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 enlicitide decanoate 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

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381 participants in 5 patient groups, including a placebo group

Enlicitide Decanoate 6 mg

Experimental group

Description:

Participants will receive 6 mg of enlicitide decanoate orally QD for 8 weeks

Treatment:

Drug: Enlicitide Decanoate

Enlicitide Decanoate12 mg

Experimental group

Description:

Participants will receive 12 mg of enlicitide decanoate orally QD for 8 weeks

Treatment:

Drug: Enlicitide Decanoate

Enlicitide Decanoate 18 mg

Experimental group

Description:

Participants will receive 18 mg of enlicitide decanoate orally QD for 8 weeks

Treatment:

Drug: Enlicitide Decanoate

Enlicitide Decanoate 30 mg

Experimental group

Description:

Participants will receive 30 mg of enlicitide decanoate orally QD for 8 weeks

Treatment:

Drug: Enlicitide Decanoate

Placebo

Placebo Comparator group

Description:

Participants will receive enlicitide decanoate-matching placebo orally QD for 8 weeks

Treatment:

Drug: Placebo