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A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)

CompletedPhase 1

Sponsor: Merck Sharp & Dohme LLC

Conditions: Hepatic Insufficiency, Hepatic Impairment

Interventions: Enlicitide

Countries: United States

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 or PK study). Researchers will compare what happens to enlicitide in the body when it is given to people with hepatic impairment (HI- meaning the liver does not work properly) and people who are in good health. This study will have 2 parts. In Part 1, enlicitide will be given to people with moderate HI and people who are in good health. After Part 1, researchers may decide to include people who have mild HI and compare what happens to enlicitide in the body with people who are in good health.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

All participants:

* Has been a non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to starting the study
* Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m2

Participants with moderate or mild HI:

* Diagnosis of chronic (\> 6 months) and stable (no sudden or severe episodes of illness due to worsening liver function in the past 2 months) hepatic insufficiency, and features cirrhosis (liver scarring) due to any cause.
* Is generally in good health with the exception of HI.

Healthy Control Participants:

* Medically healthy with no clinically significant medical history, physical examination, or clinical laboratory profiles

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

All participants:

* History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery.
* History of cancer
* Consumes greater than 3 servings of alcoholic beverages per day.
* Is on statin background therapy.

Participants with moderate or mild HI:

* Severe complications of liver disease within 3 months of entering the study.

Locations (2)

Orlando, Florida, United States
San Antonio, Texas, United States