Eli Lilly Initiates Phase III ACHIEVE-2 Study of Oral Small-Molecule GLP-1R Agonist Orforglipron Head-to-Head Against Dapagliflozin in Type 2 Diabetes

On December 29, the Drug Clinical Trial Registry and Information Disclosure Platform showed that a Phase III ACHIEVE-2 study of the GLP-1R small molecule agonist orforglipron (LY3502970) was initiated to evaluate the efficacy and safety of once-daily oral orforglipron compared with dapagliflozin in adult subjects with type 2 diabetes whose blood glucose was inadequately controlled after metformin treatment.

Orforglipron, initially developed by Chugai Pharmaceutical, is an orally available non-peptide glucagon-like peptide-1 receptor (GLP-1R) agonist. In September 2018, Eli Lilly and Company entered into a licensing agreement with Chugai Pharmaceutical, securing global development and commercialization rights for the product in exchange for a $50 million upfront payment.

ACHIEVE-2 is a randomized, open-label study designed to demonstrate the non-inferiority of orforglipron 3mg, 12mg, and/or 36mg to dapagliflozin in terms of glycemic control. Dapagliflozin was first approved for marketing in China in 2017 and can be used as monotherapy to improve glycemic control in adult patients with type 2 diabetes on the basis of diet and exercise. The primary endpoint of this 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 and 1.1% in the dulaglutide group (mean baseline 8.1%).

According to the PharmaCube database, Eli Lilly has launched multiple Phase III clinical trials for orforglipron in China.

In addition to ACHIEVE-2, there is also the ACHIEVE-3 study, which evaluates oral semaglutide in a head-to-head comparison. The enrolled population consists of adult subjects with type 2 diabetes who have inadequate glycemic control after metformin treatment; the ATTAIN-1 study aims to evaluate the efficacy and safety of orforglipron versus placebo in adult subjects with obesity or overweight with weight-related comorbidities; the ATTAIN-2 study aims to evaluate the efficacy and safety of orforglipron versus placebo in adult subjects with type 2 diabetes who are also obese or overweight.

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