Nonalcoholic Steatohapatitis Clinical Trial
Official title:
A Randomized, Double-Blind, Controlled, Multi-Center Phase 2 Study to Evaluate the Effect of Roflumilast Plus Pioglitazone on Liver Enzymes and Liver Fat Content in Subjects With Nonalcoholic SteatoHepatitis
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment