Approval Probability
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Adjusted LOA
ML Risk
MK-2828 · 2 trials · 4 indications
Blood samples will be collected to determine the AUC0-inf of MK-2828
Blood samples will be collected to determine the AUC0-last of MK-2828
Blood samples will be collected to determine the AUC0-24 of MK-2828
Blood samples will be collected to determine the Cmax of MK-2828
Blood samples will be collected to determine the Tmax of MK-2828
Blood samples will be collected to determine the C24 of MK-2828
Blood samples will be collected to determine the t1/2 of MK-2828
Blood samples will be collected to determine the CL/F of MK-2828
Blood samples will be collected to determine the Vz/F of MK-2828
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.
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.
| Arm | Type | Description |
|---|---|---|
| Severe Renal Impairment | EXPERIMENTAL | Participants with severe renal impairment will receive a single dose of MK-2828 on Day 1 |
| End Stage Renal Disease (ESRD) on Hemodialysis (HD) | EXPERIMENTAL | Participants with ESRD will receive a single dose of MK-2828 on Day 1 in each of 2 periods, with a washout of at least 14 days between doses. |
| Healthy Mean Matched Control | EXPERIMENTAL | Participants with normal renal function will receive a single dose of MK-2828 on Day 1 |
| MK-2828 | EXPERIMENTAL | Participants receive daily MK-2828 for 28 days. |
| Placebo | PLACEBO_COMPARATOR | Participants receive daily placebo for 28 days. |
| Name | Type | Description |
|---|---|---|
| MK-2828 | DRUG | Oral administration |
| Placebo | DRUG | Placebo to match MK-2828 oral capsule, taken once per day for 28 days. |
The main inclusion criteria include but are not limited to the following: * Is in generally good health, with the exception of renal impairment participants. Participants with stable, chronic medical or psychiatric conditions may be included at the discretion of the investigator and the Sponsor. S...
MK-2828 is an investigational small molecule being developed by Merck & Company, Inc. (ticker MRK) for chronic kidney failure and type 2 diabetes mellitus. It is in Phase 1 clinical development in the nephrology therapeutic area. It has been studied in two completed Phase 1 trials, one in kidney disease and one in type 2 diabetes.
MK-2828 is being studied for chronic kidney failure and type 2 diabetes mellitus. Its clinical program includes a Phase 1 trial in people with kidney disease, including end-stage renal disease and renal impairment, and a Phase 1 multiple dose study in participants with type 2 diabetes. It is investigational and not approved for any use.
MK-2828 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the Phase 1 clinical program for MK-2828, including the kidney disease study MK-2828-006 and the type 2 diabetes study MK-2828-003.
MK-2828 is in Phase 1 clinical development. Both of its recorded trials are Phase 1 studies and both are completed. MK-2828 is investigational and has not been approved by the FDA for chronic kidney failure, type 2 diabetes, or any other indication.
MK-2828 has been evaluated in two completed Phase 1 trials. NCT07348237, titled MK-2828-006, studied MK-2828 in people with kidney disease, including chronic kidney failure, end-stage renal disease, and renal impairment, enrolling 18 participants in the United States. NCT07089784, titled MK-2828-003, was a multiple dose study in participants with type 2 diabetes, enrolling 46 participants in the United States.
The MK-2828 clinical program enrolled 46 participants in its type 2 diabetes Phase 1 trial, NCT07089784, and 18 participants in its kidney disease Phase 1 trial, NCT07348237. Both studies were conducted in the United States, were controlled, and included participants aged 24 years and older.