NCT05070390

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Moderate Renal Impairment

Interventions

Type	Name	Description
DRUG	Enlicitide Chloride	10 mg capsule administered orally

Timeline

• Start date: 2021-11-16
• Primary completion: 2023-05-03
• Completion: 2023-05-03
• First posted: 2021-10-07
• Last updated: 2024-09-26
• Results posted: 2024-09-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study