Tides Express | Lilly Initiates Phase III Trial of Oral Small-Molecule GLP-1R Agonist Orforglipron

December 29, 2023, the Drug Clinical Trial Registration and Information Disclosure Platform shows,Eli LillyLaunched GLP-1R Small Molecule AgonistOrforglipron(LY3502970) The Phase III ACHIEVE-2 study aims to evaluate the efficacy and safety of once-daily oral orforglipron compared to dapagliflozin in adult subjects with type 2 diabetes whose blood glucose levels are inadequately controlled with metformin.

ACHIEVE-2 is a randomized, open-label study designed to demonstrate the non-inferiority of orforglipron 3mg, 12mg, and/or 36mg compared to dapagliflozin in terms of glycemic control. Dapagliflozin was first approved in China in 2017 and can be used as monotherapy in addition to diet and exercise to improve glycemic control in adult patients with type 2 diabetes. The primary endpoint of the study is the change in HbA1c from baseline at week 40.

Previously, Eli Lilly and Company announced the Phase II study data (NCT05048719) of orforglipron in treating patients with type 2 diabetes. For the efficacy estimand, at 26 weeks, the mean reduction in A1c was up to 2.1% in the orforglipron group, compared to 0.4% in the placebo group.DulaglutideThe group was 1.1% (average baseline 8.1%).

About Glucagon-Like Peptide 1 (GLP-1)

Glucagon-like peptide 1 (GLP-1) is a peptide hormone secreted by intestinal cells. It stimulates insulin secretion and inhibits glucagon secretion by binding to the GLP-1 receptor, thereby promoting glucose metabolism. At the same time, it can also slow gastric emptying and suppress appetite. Therefore, GLP-1 has become a powerful target for the treatment of obesity and type 2 diabetes.

AboutOrforglipron

Orforglipron, initially developed by Chugai Pharmaceutical, is an orally available non-peptideGlucagon-Like Peptide-1Receptor (GLP-1R) agonist. In September 2018, Eli Lilly and Company entered into a licensing agreement with Chugai Pharmaceutical Co., Ltd. to obtain the global development rights for the product with an upfront payment of 50 million US dollars.Commercialization Rights。

About Eli Lilly and Company

Eli Lilly and Company is a globally leading pharmaceutical company engaged in the research, development, manufacturing, and marketing of medicines, dedicated to improving human health through innovation. Eli Lilly and Company was founded over a century ago by Colonel Eli Lilly in Indianapolis, Indiana, in 1876. The company's founder was committed to producing high-quality medicines to meet real medical needs. Today, we remain steadfast in this mission and continue our work based on it. Globally, our employees are constantly striving to develop medicines that can make a difference in people’s lives and make them available to patients in genuine need. Moreover, we are also committed to enhancing public understanding of diseases and improving disease management. At the same time, we give back to society by engaging in charitable activities and volunteer work.