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drugset / Trial / NCT05070390

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

NCT05070390 ↗

Phase 1 Completed 18 enrolled Merck Sharp & Dohme LLC
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2021-11-16
Primary completion
2023-05-03
Completion
2023-05-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Enlicitide Unknown 10 mg Oral

Indications

No indication recorded.