DD01 is a dual GLP-1/glucagon receptor agonist acting through two independent pathways to provide rapid resolution of hepatic steatosis, improve glucose control, an reduce body weight in subjects with type 2 diabetes who are obese/overweight and have NAFLD. In a recently completed Phase 1 single and repeat dose safety and pharmacology study, DD01 was well tolerated and improved fasting and fed glucose while providing significant reductions in liver fat as measured by MRI-PDFF. Following only 4 weeks of once-weekly treatment, up to 100% of patients achieved ≥30% reduction in MRI-PDFF. In the high dose group, all subjects achieved at least a 40% reduction in liver fat with a mean reduction of 52% whereas the change from baseline liver fat in the placebo group was only 2.8%. Meaningful and rapid improvements in steatosis were observed at well-tolerated doses that did not cause significant weight loss, thus uncoupling the need for weight loss to precede or coincide with significant improvements in liver health.
D. To: Employee; Neuraly Inc. J. Shin: Employee; D&D Pharmatech. S. Karanth: None. Y. Lin: None. S. Sosnovtseva: None. A. C. Bell: None.
