Clinical trial NCT06655311: A Study of Enlicitide Chloride (MK-0616) in Healthy Participants and Participants Taking Statins (MK-0616-012)
Official title: Multiple-Rising Dose Clinical Study to Evaluate the Safety and Pharmacokinetics of MK-0616 in Healthy Participants and in Male and Female Participants Taking Statins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Hypercholesterolemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 56 days
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 42 days
Secondary outcomes:
measure: Area Under the Curve from Time 0 to 24 Hours (AUC0-24) of Enlicitide Chloride
timeFrame: At designated timepoints (up to approximately 24 hours)
measure: Maximum Plasma Concentration (Cmax) of Enlicitide Chloride
timeFrame: At designated timepoints (up to approximately 1 week)
measure: Plasma Concentration 24 Hours Postdose (C24) of Enlicitide Chloride
timeFrame: At designated timepoints (up to approximately 1 week)
measure: Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride
timeFrame: At designated timepoints (up to approximately 1 week)
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Chloride
timeFrame: At designated timepoints (up to approximately 1 week)
measure: Percent Change from Baseline of Plasma Low Density Lipoprotein (LDL-C) Concentration After Administration of Enlicitide Chloride
timeFrame: Baseline, Week 1
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Altasciences Clinical Kansas, Inc. (Site 0002)
state: Kansas
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: