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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-012 | Other Identifier | MSD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlicitide Chloride | Experimental | 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. |
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| Placebo | Placebo Comparator | Participants receive placebo orally for up to approximately 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlicitide Chloride | Biological | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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. | Up to approximately 56 days |
| Number of Participants Who Discontinue Study Treatment Due to an AE | 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. | Up to approximately 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve from Time 0 to 24 Hours (AUC0-24) of Enlicitide Chloride | Blood samples will be collected to determine the AUC0-24 of enlicitide chloride. | At designated timepoints (up to approximately 24 hours) |
| Maximum Plasma Concentration (Cmax) of Enlicitide Chloride |
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Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical Kansas, Inc. (Site 0002) | Overland Park | Kansas | 66212 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C000728674 | MK-0616 |
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| Placebo | Other | Oral administration |
|
Blood samples will be collected to determine the Cmax of enlicitide chloride. |
| At designated timepoints (up to approximately 1 week) |
| Plasma Concentration 24 Hours Postdose (C24) of Enlicitide Chloride | Blood samples will be collected to determine the C24 of enlicitide chloride. | At designated timepoints (up to approximately 1 week) |
| Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride | Blood samples will be collected to determine the Tmax of enlicitide chloride. | At designated timepoints (up to approximately 1 week) |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Chloride | Blood samples will be collected to determine the AUC0-Last of enlicitide chloride. | At designated timepoints (up to approximately 1 week) |
| Percent Change from Baseline of Plasma Low Density Lipoprotein (LDL-C) Concentration After Administration of Enlicitide Chloride | Blood samples will be collected to determine the LDL-C of enlicitide chloride. | Baseline, Week 1 |
| D009750 |
| Nutritional and Metabolic Diseases |