Eli Lilly said its once-daily oral GLP-1 pill, orforglipron, achieved the main and all key secondary goals in the late-stage ATTAIN-2 study, marking the candidate’s third Phase 3 success. The result completes the clinical package the company needs to seek regulatory clearance for the drug as a treatment for obesity and overweight in adults with Type 2 diabetes. The 72-week trial enrolled more than 1,600 participants across three dose groups. Patients receiving the highest 36-milligram dose lost an average 10.5 % of body weight, or about 23 pounds (10.4 kg), versus 2.2 % for placebo. Seventy-five percent of those on the top dose reduced their A1C to 6.5 % or lower, and the drug also improved cholesterol, triglycerides and blood-pressure measures. Gastro-intestinal events such as nausea (36 %) and vomiting (23 %) were the most frequent side effects; roughly one in ten high-dose recipients discontinued treatment, and no liver safety issues were reported. Lilly plans to submit global marketing applications before the end of 2025. Because orforglipron is a small-molecule tablet that can be produced and packaged more easily than injectable GLP-1 therapies such as Lilly’s own Zepbound or Novo Nordisk’s Wegovy, analysts say it could become the first commercially successful oral GLP-1 for weight management. Investors reacted positively, lifting Lilly’s shares almost 4 % to about $722 in early New York trading. The company joins Novo Nordisk in the race to bring pill-based obesity drugs to a market some analysts expect to exceed $150 billion in annual sales by the early 2030s.
イーライリリーの経口肥満症薬、2型糖尿病患者で体重10.5%減 https://t.co/TO2eE8Ovr2 https://t.co/TO2eE8Ovr2
Lilly to submit obesity pill after hitting goal in third late-stage trial https://t.co/azaJQwwFUX $LLY @ByJonGardner
While Truist Securities analysts said the results from the ATTAIN-2 trial leave “room for competition,” they also pointed to a manufacturing advantage that could unlock a “double-digit billion dollar opportunity” for @EliLillyandCo. #obesity #FDA #biospace