drugset / Trial / NCT05934292

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

NCT05934292

Phase 1 Completed 33 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-07-20
Primary completion
2024-01-19
Completion
2024-01-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Enlicitide Decanoate Unknown 20 mg Oral

Indications