A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.

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

Timeline

Start

2019-09-23

Primary completion

2021-05-06

Completion

2021-05-06

Publications

• Shankar SS, Daniels SJ, Robertson D, Sarv J, Sanchez J, Carter D, Jermutus L, Challis B, Sanyal AJ. Safety and Efficacy of Novel Incretin Co-agonist Cotadutide in Biopsy-proven Noncirrhotic MASH With Fibrosis. Clin Gastroenterol Hepatol. 2024 Sep;22(9):1847-1857.e11. doi: 10.1016/j.cgh.2024.04.017. Epub 2024 May 9.

Drugs

Indications