Conditions: Non-alcoholic Fatty Liver Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks. arm 2: Participants will receive oral doses of placebo to match MK-4074 twice daily for 4 weeks. arm 3: Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks. arm 4: Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.

Interventions: intervention 1: MK-4074 200 mg intervention 2: Placebo for MK-4074 intervention 3: Pioglitazone hydrochloride 30 mg intervention 4: Placebo for pioglitazone hydrochloride
Intervention descriptions: intervention 1: 2 x 100-mg capsules, orally, twice-daily (BID) for 4 weeks intervention 2: 2 x 100-mg capsules, orally, BID for 4 weeks. intervention 3: 1 x 30-mg tablet, orally, once daily for 4 weeks intervention 4: 1 x 30-mg tablet, orally, once daily for 4 weeks

Protocol document: