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MK-4074

Phase 1

Non-alcoholic Fatty Liver Disease | Small molecule | Gastrointestinal |Merck & Company, Inc.|Last Updated: Sep 10, 2018

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

MK-4074 · 1 trial · 1 indication

Phase 1 1
NCT01431521Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008)Non-alcoholic Fatty Liver Disease
COMPLETED31 Analytics
PHASE1COMPLETED
Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008)
Non-alcoholic Fatty Liver DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change From Baseline in Hepatic Fat
Baseline and Week 4

Hepatic fat content was assessed via magnetic resonance imaging (MRI) prior to first dose administration and following 4 weeks of treatment. Percent change in hepatic fat fraction from baseline was calculated for each of the 9 liver regions separately and then these were averaged to calculate overall percent change from baseline for each participant.

Number of Participants Experiencing One or More Adverse Events (AE)
Up to 10 weeks

An 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 Who Discontinued Study Drug Due to an AE
Up to 4 weeks

An 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.

Secondary Endpoints

Percent Change From Baseline in Alanine Transaminase (ALT)
Baseline and Week 4
Percent Change From Baseline Aspartate Transaminase (AST)
Baseline and Week 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK-4074EXPERIMENTALParticipants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
Placebo for MK-4074PLACEBO_COMPARATORParticipants will receive oral doses of placebo to match MK-4074 twice daily for 4 weeks.
PioglitazoneEXPERIMENTALParticipants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
Placebo for pioglitazonePLACEBO_COMPARATORParticipants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.

Interventions

NameTypeDescription
MK-4074 200 mgDRUG2 x 100-mg capsules, orally, twice-daily (BID) for 4 weeks
Placebo for MK-4074DRUG2 x 100-mg capsules, orally, BID for 4 weeks.
Pioglitazone hydrochloride 30 mgDRUG1 x 30-mg tablet, orally, once daily for 4 weeks
Placebo for pioglitazone hydrochlorideDRUG1 x 30-mg tablet, orally, once daily for 4 weeks
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Females must be of non-childbearing potential * Body mass index (BMI) ≥32.0 kg/m\^2 * In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests * No clinically significant abnormality on electrocardiogram * Has document...

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Frequently asked questions about MK-4074

What is MK-4074 used for?

MK-4074 is an investigational small molecule being studied for the treatment of non-alcoholic fatty liver disease (NAFLD). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes MK-4074?

MK-4074 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK.

What phase is MK-4074 in?

MK-4074 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 trial has been completed.

What clinical trials is MK-4074 in?

MK-4074 has been studied in one completed Phase 1 clinical trial, identified as NCT01431521. This trial evaluated changes in hepatic fat following administration of MK-4074 and pioglitazone hydrochloride in patients with non-alcoholic fatty liver disease.

Is MK-4074 the same as pioglitazone?

No, MK-4074 is not the same as pioglitazone. In the clinical trial NCT01431521, MK-4074 was studied alongside pioglitazone hydrochloride, but they are separate drugs.