Conditions: Nonalcoholic Steatohapatitis
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effect of roflumilast and pioglitazone therapy on serum transaminase (ALT) levels in adults with Nonalcoholic SteatoHepatitis.

Detailed description:
This proof of concept study will evaluate the effect of roflumilast and pioglitazone on transaminase levels and liver fat content.

Takeda has chosen not to continue this Study, however, randomized subjects were allowed to complete the study per protocol.

The decision to terminate the study is not related to any safety concerns with either of the study medications.

Arms:
arm 1: Roflumilast dose and pioglitazone dose, orally for up to 4 months arm 2: Roflumilast dose and pioglitazone matching-placebo dose orally for up to 4 months. arm 3: Pioglitazone dose, orally and roflumilast matching-placebo dose, orally for up to 4 months

Interventions: intervention 1: Roflumilast intervention 2: Pioglitazone intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Roflumilast dose intervention 2: Pioglitazone dose intervention 3: Pioglitazone placebo-matching dose intervention 4: Roflumilast placebo-matching dose

Protocol document: