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MK8245

Phase 1

Type 2 Diabetes | Small molecule | Metabolic |Merck & Company, Inc.|Trials Updated: Sep 10, 2018

MK8245 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment70

FDA Designations

No designations recorded

MK8245 clinical trials

MK8245 · 2 trials · 2 indications

Phase 1 2
NCT00972322Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)Type 2 Diabetes Mellitus
COMPLETED56 Analytics
NCT00790556A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)Type 2 Diabetes
COMPLETED14 Analytics
PHASE1COMPLETED
Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)
Type 2 Diabetes MellitusUnlock trial analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)
Baseline and Day 28

The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A "weighted" rather than a "simple" mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose.

Number of Participants Who Experienced Serious or Non-serious Adverse Events
Up to Day 31

An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. A serious AE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Number of Participants Discontinuing Study Drug Due to an AE
Up to Day 28

An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)
56 days

An LAE is defined as any unfavorable \& unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A CAE is defined similarly but also includes changes in structure or function of the body. Serious AEs are those occuring that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc. Drug-relatedness was determined by the investigator based on clinical judgement.

Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14
Day 14 of each 14-day Treatment Period

Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK-8245 50 mgEXPERIMENTALMK-8245, 50 mg, twice daily for 28 days
PlaceboPLACEBO_COMPARATORPlacebo to MK-8245, 50 mg, twice daily
1EXPERIMENTALMK8245
2PLACEBO_COMPARATORPlacebo Comparator

Interventions

NameTypeDescription
MK-8245DRUGMK-8245 50 mg twice daily for 28 days
Comparator: placeboDRUGmatching placebo to MK-8245 twice daily for 28 days
MK8245DRUGMK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents * Subject is willing to follow a weight-maintaining diet and exercise program during the ...

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Frequently asked questions about MK8245

What is MK8245?

MK8245 is an investigational small molecule developed by Merck & Company, Inc. for the treatment of Type 2 Diabetes and Type 2 Diabetes Mellitus. It is a Phase 1 clinical candidate in the metabolic therapeutic area and has been studied in placebo-controlled, double-blind, randomized Phase 1 trials.

What is MK8245 used for in Type 2 Diabetes?

MK8245 is being evaluated for the treatment of Type 2 Diabetes and Type 2 Diabetes Mellitus. It is an investigational small molecule in Phase 1 development, and its clinical program has focused on pharmacokinetics and pharmacodynamics in participants with Type 2 Diabetes.

Who makes MK8245?

MK8245 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 1 clinical studies of the compound in participants with Type 2 Diabetes.

What phase is MK8245 in?

MK8245 is in Phase 1 clinical development. It is investigational and has not been approved for any indication. The Phase 1 program has been completed, with no active trials currently listed for the compound.

What clinical trials is MK8245 in?

MK8245 has been studied in two completed Phase 1 trials: NCT00972322, which evaluated pharmacokinetics and pharmacodynamics in participants with Type 2 Diabetes, and NCT00790556, which assessed safety, tolerability, pharmacokinetics and pharmacodynamics. Both trials are completed.

Is MK8245 the same as MK-8245?

Yes, MK8245 and MK-8245 refer to the same investigational compound. MK-8245 is the hyphenated form of the name used in Merck's Phase 1 study titles, including NCT00972322 and NCT00790556, both conducted in participants with Type 2 Diabetes.