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ORMD-0701 is a novel **oral formulation of human leptin**, developed to allow leptin administration by mouth rather than by injection. Leptin is a hormone involved in the regulation of appetite, energy expenditure, food absorption, intestinal motility, and inflammatory processes. In diabetes research, leptin has been shown to inhibit glucose uptake, reduce glucagon levels, and decrease insulin requirements in mouse models, as well as to ameliorate hyperglycemia and reduce insulin demand in type 1 diabetes patients. ORMD-0701 uses a species-specific protease inhibitor to protect leptin from degradation in the gastrointestinal tract, and a potent absorption enhancer to facilitate uptake across the intestinal epithelium. Current evidence involves first-in-human, placebo-controlled studies in patients with type 1 diabetes, suggesting ORMD-0701 is safe, transiently lowers glucose, and modulates insulin-glucagon balance[1][3][5][9].
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