CompletedPhase 1

A Study of Enlicitide Chloride (MK-0616) in Healthy Participants and Participants Taking Statins (MK-0616-012)

United States56 participantsStarted 2022-09-30

Plain-language summary

The goal of this study is to learn what happens to different doses of enlicitide chloride over time in the body of healthy participants and participants taking statins, a group of medicines used to reduce the levels of high cholesterol in the bloodstream. The researchers want to learn about the safety of enlicitide chloride when administered at high doses.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization * Has a body mass index (BMI)≥18 and ≤32 kg/m\^2 Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major (including stroke and chronic seizures) abnormalities or diseases * Has a history of cancer

What they're measuring

Number of Participants Who Experience an Adverse Event (AE)

Timeframe: Up to approximately 56 days

Number of Participants Who Discontinue Study Treatment Due to an AE

Timeframe: Up to approximately 42 days

Trial details

NCT IDNCT06655311

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-02

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