In a Phase 2a clinical trial in 36 subjects with NASH (Nonalcoholic steatohepatitis, or “fatty liver”) and the metabolic syndrome, oral aCD3 immunotherapy was safe and well-tolerated, and induced positive trends in clinical biomarkers in groups receiving oral anti-CD3 but not in the placebo group – some of these trends were statistically significant in spite of the very small group sizes. These positive effects were reduced blood levels of two enzymes that are biomarkers for liver inflammation which is a favorable outcome for subjects with NASH, and reduced blood levels of glucose and triglycerides and improved performance in glucose tolerance testing which is a favorable outcome for subjects with type-2 diabetes or altered glucose metabolism.