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MK-6213

Phase 2

Hypercholesterolemia | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Jan 14, 2019

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment334

FDA Designations

No designations recorded

Clinical trial landscape

MK-6213 · 1 trial · 1 indication

Phase 2 1
NCT00687271A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006)Hypercholesterolemia
COMPLETED334 Analytics
PHASE2COMPLETED
A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006)
HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Baseline (predose) and Week 4

Blood collected at baseline (predose) and after 4 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by reflex beta-quantitation method. The percentage change from baseline at Week 4 was summarized.

Secondary Endpoints

Percentage of Participants Who Experience at Least 1 Adverse Event (AE)
Up to 14 days post last dose of study drug (up to 6 weeks)
Percentage of Participants That Had Study Drug Discontinued Due to an AE
up to 4 weeks
Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Baseline (predose) and Week 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK-6213 160 mg + Atorvastatin 20 mgEXPERIMENTAL1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks
Atorvastatin 20 mgACTIVE_COMPARATOR1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks
MK-6213 160 mgEXPERIMENTAL1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks
PlaceboPLACEBO_COMPARATOR1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks

Interventions

NameTypeDescription
MK-6213DRUGMK-6213 160 mg for 4 weeks.
Atorvastatin calciumDRUGatorvastatin calcium 20mg for 4 weeks.
Placebo for MK-6312 160 mgDRUG -
Placebo for Atorvastatin 20 mgDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * 18 to 75 years of age at the time of the study with high cholesterol * Can have diabetes mellitus but is not currently on lipid lowering therapy * Have a stable weight for \>6 weeks Exclusion Criteria: * Has significant cardiovascular (heart), renal (kidney), neurologic (ner...

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Frequently asked questions about MK-6213

What is MK-6213 used for?

MK-6213 is an investigational small molecule being studied for the treatment of hypercholesterolemia, a condition of high cholesterol levels in the blood. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 2 clinical development.

What does MK-6213 target?

MK-6213 is a small molecule developed by Merck & Company, Inc. (MRK) for hypercholesterolemia. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated for its ability to lower cholesterol when co-administered with atorvastatin.

Who makes MK-6213?

MK-6213 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is an investigational small molecule intended for the treatment of hypercholesterolemia.

What phase is MK-6213 in?

MK-6213 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial of MK-6213 has been completed, and the drug is being studied for hypercholesterolemia.

What clinical trials is MK-6213 in?

MK-6213 has one completed Phase 2 clinical trial, identified as NCT00687271. This randomized, double-blind, placebo-controlled study evaluated MK-6213 co-administered with atorvastatin in 334 participants with hypercholesterolemia. The trial enrolled adults aged 18 years and older.

Is MK-6213 the same as other cholesterol drugs?

MK-6213 is an investigational small molecule developed by Merck & Company, Inc. (MRK) for hypercholesterolemia. It has been studied in combination with atorvastatin, a commonly used statin, but its relationship to other cholesterol-lowering medications has not been disclosed in available clinical trial information.