A Study of Enlicitide Chloride (MK-0616) in Healthy Participants and Participants Taking Statins (MK-0616-012)
- Conditions
- HealthyHypercholesterolemia
- Interventions
- Other: Placebo
- Registration Number
- NCT06655311
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enlicitide Chloride Enlicitide Chloride Participants receive enlicitide chloride titrated orally from Dose 1, Dose 2, or Dose 3 once daily (QD) over the course of a 14-day treatment for each dose based on the safety and tolerability of the previous starting dose. The total treatment duration is up to approximately 6 weeks. Placebo Placebo Participants receive placebo orally for up to approximately 6 weeks.
- Primary Outcome Measures
Name Time Method Number of Participants Who Experience an Adverse Event (AE) Up to approximately 56 days An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE Up to approximately 42 days An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
- Secondary Outcome Measures
Name Time Method Area Under the Curve from Time 0 to 24 Hours (AUC0-24) of Enlicitide Chloride At designated timepoints (up to approximately 24 hours) Blood samples will be collected to determine the AUC0-24 of enlicitide chloride.
Maximum Plasma Concentration (Cmax) of Enlicitide Chloride At designated timepoints (up to approximately 1 week) Blood samples will be collected to determine the Cmax of enlicitide chloride.
Plasma Concentration 24 Hours Postdose (C24) of Enlicitide Chloride At designated timepoints (up to approximately 1 week) Blood samples will be collected to determine the C24 of enlicitide chloride.
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride At designated timepoints (up to approximately 1 week) Blood samples will be collected to determine the Tmax of enlicitide chloride.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Chloride At designated timepoints (up to approximately 1 week) Blood samples will be collected to determine the AUC0-Last of enlicitide chloride.
Percent Change from Baseline of Plasma Low Density Lipoprotein (LDL-C) Concentration After Administration of Enlicitide Chloride Baseline, Week 1 Blood samples will be collected to determine the LDL-C of enlicitide chloride.
Trial Locations
- Locations (1)
Altasciences Clinical Kansas, Inc. (Site 0002)
🇺🇸Overland Park, Kansas, United States