Eli Lilly: New Long-Acting Glucagon-Insulin Receptor Agonist Approved for Clinical Trials in China

On March 5, according to Eli Lilly (LLY.US), the company’s recently developed Eloralintide was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China, and three global pivotal Phase III clinical studies are being conducted in China at the same time. These studies are intended to support future registration in China for multiple indications such as weight management for this product, in order to meet the clinical needs of patients with obesity or overweight and their related comorbidities, and to provide more effective treatment options with good tolerability.

As described, Eloralintide is a potent, selective, long-acting amylin receptor agonist (AMYR) that can bind to human amylin receptor 1 (AMY1R) with high affinity, while maintaining selectivity for the human calcitonin receptor (hCTR). It achieves a balance of efficacy and tolerability by improving gastrointestinal reactions while maintaining weight loss effects.

This time, the CDE approved China to join three global Phase III pivotal studies of Eloralintide, to support global concurrent development and registration of Eloralintide alone or in combination with stable-dose incretin-mimetic drugs for weight-loss management in adults.