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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-032 | Other Identifier | MSD |
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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 (PK) study). Researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do not work properly) and to people who are in good health. The researchers believe that the total amount of enlicitide in a person's body measured during the 24 hours after a dose will be similar in people with severe renal impairment and in healthy people.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A: Severe Renal Impairment | Experimental | Participants with severe renal impairment receive enlicitide once daily (QD) for 28 days. |
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| Panel B: Healthy | Experimental | Healthy participants receive enlicitide QD for 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlicitide | Drug | Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma | AUC0-24 of enlicitide in plasma will be determined. | Pre-dose and at designated time points up to 24 hours post dose on Day 28 |
| Maximum plasma concentration (Cmax) of enlicitide in plasma | Cmax of enlicitide in plasma will be determined. | Pre-dose and at designated time points up to 24 hours post dose on Day 28 |
| Time to maximum plasma concentration (Tmax) of enlicitide in plasma | Tmax of enlicitide in plasma will be determined. | Pre-dose and at designated time points up to 24 hours post dose on Day 28 |
| Apparent Clearance (CL/F) of enlicitide in plasma | CL/F of enlicitide in plasma will be determined. | Pre-dose and at designated time points up to 24 hours post dose on Day 28 |
| Apparent volume of distribution during terminal phase (Vz/F) of enlicitide in plasma | Vz/F of enlicitide in plasma will be determined. | Pre-dose and at designated time points up to 24 hours post dose on Day 28 |
| Number of participants who experience one or more adverse events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 42 days |
| Number of participants who discontinue study intervention due to an AE |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Panel A: Participants with Severe Renal Impairment:
- History of any illness, other than hypercholesterolemia and Renal Impairment
Panel B: Healthy Participants:
- History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases, other than hypercholesterolemia
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research, New Smyrna Beach ( Site 0003) | Edgewater | Florida | 32132 | United States | ||
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 4, 2026 | |
| Reset | Jun 30, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 4, 2026 | Jun 30, 2026 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000728674 | MK-0616 |
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Up to approximately 28 days |
| Velocity Clinical Research, Hallandale Beach ( Site 0006) |
| Hallandale |
| Florida |
| 33009 |
| United States |
| Nature Coast Clinical Research - Inverness ( Site 0002) | Inverness | Florida | 34452 | United States |
| Jacksonville Center for Clinical Research ( Site 0004) | Jacksonville | Florida | 32216 | United States |
| Genesis Clinical Research, LLC ( Site 0001) | Tampa | Florida | 33603 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |