Status:
COMPLETED
A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatic Insufficiency
Hepatic Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 wil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06575959
Start Date
September 20 2024
End Date
May 8 2025
Last Update
May 28 2025
Active Locations (2)
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1
Orlando Clinical Research Center ( Site 0002)
Orlando, Florida, United States, 32809
2
The Texas Liver Institute ( Site 0001)
San Antonio, Texas, United States, 78215