In August 2021, we announced positive topline data from our Phase 1a/1b study of CB4211 under development for NASH and obesity. The Phase 1b portion of trial was a 4 week, multi-center, randomized, double blind, placebo-controlled clinical study in 20 obese subjects with fatty liver disease.
Results: The study met its primary endpoint showing that CB4211 was well-tolerated and appeared safe with no serious adverse events. Evaluation of the exploratory pharmacodynamic endpoints from the Phase 1b stage of the study comparing CB4211 to placebo demonstrated robust and significant reductions in key biomarkers of liver damage, ALT and AST, a significant decrease in glucose levels, and a trend towards lower body weight after four weeks of treatment. Both the CB4211 and placebo groups had substantial reductions in liver fat content compared to baseline.
Key findings from the study are summarized below.
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