Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-20

Study Completion Date

2024-01-19

Brief Summary

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The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment (moderate, severe, end stage renal disease \[ESRD\]) to those of healthy mean matched control participants on a background of statin therapy. There is no formal hypothesis.

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Detailed Description

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Panel C included participants with ESRD. No urine samples could be obtained on Panel C participants and hence no pharmacokinetic (PK) analysis could be performed for Panel C participants as pre-specified in the protocol.

Conditions

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Hypercholesterolaemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Panel A: Moderate Renal Impairment (RI)

Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1

Group Type EXPERIMENTAL

Enlicitide Decanoate

Intervention Type DRUG

Oral dose

Panel B: Severe RI

Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1

Group Type EXPERIMENTAL

Enlicitide Decanoate

Intervention Type DRUG

Oral dose

Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)

Participants receive Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16.

Group Type EXPERIMENTAL

Enlicitide Decanoate

Intervention Type DRUG

Oral dose

Panel D: Healthy Controls

Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.

Group Type EXPERIMENTAL

Enlicitide Decanoate

Intervention Type DRUG

Oral dose

Interventions

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Enlicitide Decanoate

Oral dose

Intervention Type DRUG

Other Intervention Names

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MK-0616

Eligibility Criteria

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Inclusion Criteria

* Be in good health with the exception of renal impairment (RI) and hypercholesterolemia for participants in Panels A, B, and C. Participants with RI that have stable, chronic medical or psychiatric conditions, including but not limited to hypertension, hypercholesterolemia, diabetes mellitus, hyper- or hypothyroidism, gout, and chronic anxiety or depression may be included at the discretion of the investigator
* Body Mass Index (BMI) ≥ 18 kg/m\^2 and ≤ 40 kg/m\^2, inclusive
* Be on a stable dose of any statin therapy defined as: no changes to dose or type of statin therapy for at least 2 months prior to Screening and participant anticipates no changes to statin therapy throughout the study until the poststudy visit

Exclusion Criteria

* History or presence of renal artery stenosis
* Had a functioning renal transplant in the past 5 years and is taking transplant medication
* Participants in panels A, B and D: Has rapidly fluctuating renal function as determined by historical measurements
* Has a history gastrointestinal disease which might affect food and drug absorption, as determined by the investigator, or has had gastric bypass or similar surgery
* History of cancer (malignancy)
* History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
* Has received an anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) small molecule treatment, monoclonal antibody, or short interfering RNA (siRNA) or RNA interference (ie, Inclisiran) within 12 months prior to Screening
* Participants with RI (Panels A, B, and C): Taking medications to treat chronic medical conditions and/or conditions associated with renal disease, if participant has not been on a stable regimen for at least 1 month (other than statins, which require a stable dose for at least 2 months) prior to administration of the initial dose of study intervention, and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 4 hours after administration of study intervention
* Participated in another investigational study within 4 weeks prior to the prestudy (screening) visit
* Consumes greater than 3 servings of alcoholic beverages per day
* Consumes excessive amounts, defined as greater than 6 servings of caffeinated beverages per day

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes