NCT05934292

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

An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of MK-0616 in Participants With Varying Degrees of Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

Panel C included participants with ESRD. No urine samples could be obtained on Panel C participants and hence no pharmacokinetic (PK) analysis could be performed for Panel C participants as pre-specified in the protocol.

Conditions

• Hypercholesterolaemia

Interventions

Type	Name	Description
DRUG	Enlicitide Decanoate	Oral dose

Timeline

• Start date: 2023-07-20
• Primary completion: 2024-01-19
• Completion: 2024-01-19
• First posted: 2023-07-06
• Last updated: 2025-02-17
• Results posted: 2025-02-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study