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The purpose of this study is to learn about the safety and if people tolerate a study medicine called MK-2828. The study will also measure what happens to MK-2828 in the body of a person with type 2 diabetes (T2D) over time (pharmacokinetic or PK study), and how it affects the amount of high-sensitivity C-reactive protein (hsCRP) in a person's blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-2828 | Experimental | Participants receive daily MK-2828 for 28 days. |
|
| Placebo | Placebo Comparator | Participants receive daily placebo for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-2828 | Drug | Oral capsule of MK-2828 taken once per day for 28 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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 Treatment Due to an AE | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of MK-2828 at 24 Hours Postdose (C24) After Day 1 Dose | Blood samples will be collected to determine the C24 of MK-2828 in plasma after the Day 1 dose. | 24 hours post-Day 1 dose |
| Plasma Concentration of MK-2828 at 24 Hours Postdose (C24) After Day 27 Dose |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProSciento Inc. ( Site 0004) | Chula Vista | California | 91911 | United States | ||
| California Clinical Trials Medical Group managed by PAREXEL ( Site 0008) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Placebo |
| Drug |
Placebo to match MK-2828 oral capsule, taken once per day for 28 days. |
|
Blood samples will be collected to determine the C24 of MK-2828 in plasma after the Day 27 dose. |
| Predose on Day 28 |
| Change from Baseline in Placebo Corrected High-Sensitivity C-Reactive Protein (hsCRP) Serum Concentration | Blood samples will be collected to determine the change from baseline in placebo corrected hsCRP. | Baseline and Predose Day 28 |
| Glendale |
| California |
| 91206 |
| United States |
| Velocity Clinical Research, Hallandale Beach ( Site 0010) | Hallandale | Florida | 33009 | United States |
| Jacksonville Center for Clinical Research ( Site 0002) | Jacksonville | Florida | 32216 | United States |
| Advanced Pharma CR, LLC ( Site 0001) | Miami | Florida | 33147 | United States |
| QPS Miami Research Associates ( Site 0005) | South Miami | Florida | 33143 | United States |
| AMR Lexington ( Site 0012) | Lexington | Kentucky | 40509 | United States |
| Alliance for Multispecialty Research, LLC ( Site 0013) | Kansas City | Missouri | 64114 | United States |
| Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0009) | Springfield | Missouri | 65802 | United States |
| AMR Clinical ( Site 0003) | Knoxville | Tennessee | 37920 | United States |
| ICON Early Phase Services ( Site 0006) | San Antonio | Texas | 78209 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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