The Effect of Food and Water Volume in Healthy Adult Participants Administered Enlicitide Decanoate (MK-0616) (MK-0616-022)

Completed · Phase 1

Conditions studied: Healthy

In brief

Enlicitide decanoate (MK-0616, the study medicine) is in a class of medicines that have been shown to reduce LDL-C. Enlicitide decanoate is different from the other medicines in this class because it is taken as a tablet and not an injection. The goal of this study is to see what happens to doses of enlicitide decanoate in a person's body over time. During the study, researchers will measure people's blood samples for the amount of enlicitide decanoate when taken with food or on an empty stomach, or when taken with high, medium, and low volumes of water. Researchers also want to learn about the safety of enlicitide decanoate, including how well people tolerate (manage) it.

Key facts

Study ID

NCT06658652

Run by

Merck Sharp & Dohme LLC

People needed

34

Starts

2023-10-24

Expected to finish

2023-12-26

Last updated by the study team

2024-10-26

Who can join

Age: 18 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:
• Has body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2
• Is medically healthy with no clinically significant medical history

You may not qualify if…

• The key exclusion criteria include but are not limited to the following:
• Has history of gastrointestinal disease which may affect food and drug absorption
• Has history of cancer (malignancy).

Where it is running

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

Full record on ClinicalTrials.gov

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