礼来口服减肥药三期数据出炉：平均减重 10.5%，将启动全球申报

According to Zhitong Finance APP, Eli Lilly (LLY.US) announced on Tuesday that its oral weight loss therapy orforglipron achieved its primary goal in the Phase 3 trial, and the company will proceed with the global registration application for this once-daily GLP-1 receptor agonist.

Eli Lilly cited the top-line data from its ATTAIN-2 Phase 3 trial, stating that according to the protocol-specified analysis, orforglipron achieved the primary endpoint with an average weight loss of 22.9 pounds (10.5%) over 72 weeks at the highest dose. Meanwhile, the data evaluated using the gold standard of clinical trial data—the intention-to-treat analysis—showed that orforglipron achieved a weight loss effect of 9.6% at the highest tested dose of 36mg.

This international study involved over 1,600 adult patients with obesity or overweight and type 2 diabetes, and the trial met all primary and secondary endpoints, including key diabetes biomarker glycated hemoglobin (A1C) related indicators. Eli Lilly stated that orforglipron reduced the baseline A1C level of 8.1% by 1.3% to 1.8% across three tested doses.

In terms of safety, the company noted that the tolerability profile of orforglipron was consistent with other drugs in the GLP-1 receptor agonist class. However, the treatment discontinuation rates due to adverse events ranged from 6.1% to 10.6% across the three dose levels, compared to 4.6% in the placebo group. Meanwhile, the overall treatment discontinuation rates for the 6mg, 12mg, and 36mg dose groups were 19.1%, 22.3%, and 20.5%, respectively, while the placebo group was at 20%.

"With the completion of the ATTAIN-2 trial, Eli Lilly now has the complete clinical data package needed to initiate the global registration application for orforglipron," the company stated, adding that the complete study results will be presented at future medical conferences and submitted for publication.

Earlier this month, Eli Lilly announced that the experimental therapy achieved its primary endpoint and all key secondary endpoints in its ATTAIN-1 Phase 3 trial, with the highest dose group achieving an average weight loss of 12.4% (27.3 pounds) over 72 weeks. However, as this reading did not meet Wall Street's high expectations, Eli Lilly's stock price fell in response