NCT06643377

A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)

An Open-Label, Multiple-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Severe Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward, The purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic (PK) study). Researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do not work properly) and to people who are in good health. The researchers believe that the total amount of enlicitide in a person's body measured during the 24 hours after a dose will be similar in people with severe renal impairment and in healthy people.

Conditions

• Healthy
• Renal Impairment

Interventions

Type	Name	Description
DRUG	Enlicitide	Oral tablet

Timeline

• Start date: 2024-11-22
• Primary completion: 2025-06-25
• Completion: 2025-06-25
• First posted: 2024-10-16
• Last updated: 2025-07-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study