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

Last updated: February 12, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

1

Condition

Hypercholesterolemia

Treatment

Enlicitide Decanoate

MK-0616

Clinical Study ID

NCT05934292
0616-020
MK-0616-020
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be in good health with the exception of renal impairment (RI) andhypercholesterolemia for participants in Panels A, B, and C. Participants with RIthat have stable, chronic medical or psychiatric conditions, including but notlimited to hypertension, hypercholesterolemia, diabetes mellitus, hyper- orhypothyroidism, gout, and chronic anxiety or depression may be included at thediscretion 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 ofstatin therapy for at least 2 months prior to Screening and participant anticipatesno changes to statin therapy throughout the study until the poststudy visit

Exclusion

Exclusion Criteria:

  • History or presence of renal artery stenosis

  • Had a functioning renal transplant in the past 5 years and is taking transplantmedication

  • Participants in panels A, B and D: Has rapidly fluctuating renal function asdetermined 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 anaphylacticreaction or significant intolerability to prescription or nonprescription drugs orfood

  • Has received an anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) smallmolecule treatment, monoclonal antibody, or short interfering RNA (siRNA) or RNAinterference (ie, Inclisiran) within 12 months prior to Screening

  • Participants with RI (Panels A, B, and C): Taking medications to treat chronicmedical conditions and/or conditions associated with renal disease, if participanthas not been on a stable regimen for at least 1 month (other than statins, whichrequire a stable dose for at least 2 months) prior to administration of the initialdose of study intervention, and/or is unable to withhold the use of themedication(s) within 4 hours prior to and 4 hours after administration of studyintervention

  • 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 caffeinatedbeverages per day

Study Design

Total Participants: 33
Treatment Group(s): 2
Primary Treatment: Enlicitide Decanoate
Phase: 1
Study Start date:
July 20, 2023
Estimated Completion Date:
January 19, 2024

Study Description

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.

Connect with a study center

  • Velocity Clinical Research, Hallandale Beach ( Site 0003)

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Advanced Pharma CR, LLC ( Site 0001)

    Miami, Florida 33147
    United States

    Site Not Available

  • Clinical Pharmacology of Miami ( Site 0005)

    Miami, Florida 33014-3616
    United States

    Site Not Available

  • Orlando Clinical Research Center ( Site 0004)

    Orlando, Florida 32809
    United States

    Site Not Available

  • Genesis Clinical Research, LLC ( Site 0002)

    Tampa, Florida 33603
    United States

    Site Not Available

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