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Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008)

NCT01431521 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-09-10

Study results available
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Summary

This study will evaluate changes in liver fat content following multiple oral doses of MK-4074 and Pioglitazone Hydrochloride in adult males and females with fatty liver disease. The primary hypothesis of the study is that a multiple-dose administration of MK-4074 200 mg twice daily for 4 weeks results in a decrease in hepatic fat content with respect to placebo in adult male and female participants with hepatic steatosis (i.e., on order of 50% reduction in hepatic fat with respect to placebo is expected).

Conditions

  • Non-alcoholic Fatty Liver Disease

Interventions

DRUG

MK-4074 200 mg

2 x 100-mg capsules, orally, twice-daily (BID) for 4 weeks

DRUG

Placebo for MK-4074

2 x 100-mg capsules, orally, BID for 4 weeks.

DRUG

Pioglitazone hydrochloride 30 mg

1 x 30-mg tablet, orally, once daily for 4 weeks

DRUG

Placebo for pioglitazone hydrochloride

1 x 30-mg tablet, orally, once daily for 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-26
Primary Completion
2012-09-18
Completion
2012-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01431521 on ClinicalTrials.gov