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COMPLETED
NCT05070390
PHASE1

A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This study evaluated the safety, tolerability and pharmacokinetic (PK) effects of enlicitide chloride in participants with moderate renal impairment (RI) to those of healthy matched control participants. Moderate RI was defined as the estimated glomerular filtration rate (eGFR) ≥30 and \<60milliliter/minute/1.73meters\^2 (ml/min/1.73m\^2). There is no formal hypothesis.

Official title: An Open-Label Clinical Study to Evaluate the Pharmacokinetics of MK-0616 Following Administration of a Single Dose to Participants With Moderate Renal Impairment

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2021-11-16

Completion Date

2023-05-03

Last Updated

2026-08-19

Healthy Volunteers

Yes

Interventions

DRUG

Enlicitide Chloride

10 mg capsule administered orally

Locations (2)

Velocity Clinical Research, Hallandale Beach ( Site 0002)

Hallandale, Florida, United States

Alliance for Multispecialty Research, LLC ( Site 0001)

Knoxville, Tennessee, United States