CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
MK-4074 200 mg +3 moredrug
Likely dose
MK-4074 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01431521
NCT01431521Phase 1Completed
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An Exploratory Study to Evaluate Changes in Hepatic Fat Following Multiple-Dose Administration of MK-4074 and Pioglitazone Hydrochloride

Merck Sharp & Dohme LLC·interventional·Posted Sep 9, 2011·Updated Sep 10, 2018

In Brief

A Phase 1 clinical trial evaluating MK-4074 200 mg, Placebo for MK-4074, and 2 other interventions for Non-alcoholic Fatty Liver Disease. Completed, enrolled 31 participants.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-alcoholic Fatty Liver Disease
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2011
Enrollment StartOct 26, 2011
Primary CompletionSep 18, 2012
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.8 years ago

Interventions

MK-4074 200 mgdrug

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

Placebo for MK-4074drug

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

Pioglitazone hydrochloride 30 mgdrug

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

Placebo for pioglitazone hydrochloridedrug

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