Phase
Condition
Hypercholesterolemia
Treatment
Enlicitide Decanoate
MK-0616
Clinical Study ID
Ages 18-85 All Genders Accepts Healthy Volunteers
Study Summary
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
Study Description
Connect with a study center
Velocity Clinical Research, Hallandale Beach ( Site 0003)
Hallandale Beach, Florida 33009
United StatesSite Not Available
Advanced Pharma CR, LLC ( Site 0001)
Miami, Florida 33147
United StatesSite Not Available
Clinical Pharmacology of Miami ( Site 0005)
Miami, Florida 33014-3616
United StatesSite Not Available
Orlando Clinical Research Center ( Site 0004)
Orlando, Florida 32809
United StatesSite Not Available
Genesis Clinical Research, LLC ( Site 0002)
Tampa, Florida 33603
United StatesSite Not Available

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