At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacodynamic Effects of MEDI0382 in Obese Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)/ Non-Alcoholic Steatohepatitis (NASH)
In Brief
A Phase 2 clinical trial evaluating MEDI0382 high dose, Placebo for MEDI0382 high dose, and 2 other interventions for Non-alcoholic Fatty Liver Disease (NAFLD) and Non-alcoholic Steatohepatitis (NASH). Completed, enrolled 74 participants across 27 sites in 2 countries.
Detailed Summary
A Phase 2 study with 4 treatment groups of two differing doses and matched placebos designed to evaluate the safety (including hepatic safety), tolerability and pharmacodynamic effects of two dose levels of MEDI0382 in obese subjects with non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH). The subjects will have biopsy-confirmed NAFLD/NASH with liver fibrosis stage F1, F2 or F3. Approximately 72 subjects will be randomized
Study Details
Timeline
Interventions
MEDI0382 high dose administered subcutaneously
Placebo for MEDI0382 high dose administered subcutaneously
MEDI0382 low dose administered subcutaneously
Placebo for MEDI0382 low dose administered subcutaneously