A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031)

Completed · Phase 1

Conditions studied: Healthy

In brief

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 the effect of this new study medicine enlicitide on digoxin (medicine used in heart disease) over time (a pharmacokinetic or PK study). Researchers will compare what happens to digoxin in the body over time when it is given with this new study medicine enlicitide in healthy adult participants.

Key facts

Study ID

NCT06597760

Run by

Merck Sharp & Dohme LLC

People needed

24

Starts

2024-10-07

Expected to finish

2024-11-15

Last updated by the study team

2024-11-29

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The key inclusion criteria include but are not limited to the following:
• Is in good health before randomization
• Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive

You may not qualify if…

• The key exclusion criteria include but are not limited to the following:
• Has a history of clinically significant psychiatric, immunological, gastrointestinal, cardiovascular abnormalities or diseases.
• Has a history of cancer.
• Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.

Where it is running

• Celerion ( Site 0001) — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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