drugset / Trial / NCT01431521

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

NCT01431521

Phase 1 Completed 31 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-4074 Unknown 200 mg Oral
Subject Pioglitazone Small molecule 30 mg Oral

Indications