Eli Lilly's Obesity Pill Orforglipron Gets FDA Clearance After Successful Trial

Eli Lilly's obesity pill, orforglipron, has achieved the main goals in its third Phase 3 trial, allowing for global regulatory submissions. The once-daily GLP-1 receptor agonist is a potential treatment for weight loss. Lilly plans to submit the data to the FDA and other regulatory agencies.

Title: Eli Lilly's Orforglipron Achieves Phase 3 Trial Success, Advancing Global Regulatory Submissions

Eli Lilly and Company (LLY) has announced a significant milestone in its efforts to combat obesity, with its oral weight loss therapy, orforglipron, demonstrating substantial efficacy in a Phase 3 trial. The drug, a once-daily GLP-1 receptor agonist, has achieved its primary endpoint in the ATTAIN-2 trial, paving the way for global regulatory submissions [1].

The Phase 3 ATTAIN-2 trial, which involved 1,600 participants with obesity or overweight and at least one weight-related comorbidity, showed that orforglipron, when combined with a reduced-calorie diet and increased physical activity, led to an average weight loss of 22.9 pounds (10.5%) over 72 weeks at the highest dose [2]. This result surpasses the weight loss observed in previous trials of other weight loss medications, positioning orforglipron as a promising new treatment option in the global obesity crisis.

The safety profile of orforglipron was also evaluated during the trial. Common adverse events, such as nausea, diarrhea, and constipation, were generally mild to moderate in severity and resolved over time. No new safety signals were identified, indicating an acceptable overall safety profile for the drug [2].

With these positive results, Eli Lilly is now moving forward with global regulatory submissions for orforglipron. The company plans to submit applications to regulatory authorities in various regions, including the FDA. If approved, orforglipron could become a significant addition to the current landscape of weight loss treatments, offering a new oral option for individuals struggling with obesity or overweight.

The success of orforglipron in the Phase 3 trial underscores the ongoing efforts of pharmaceutical companies to develop effective and safe treatments for obesity. With the prevalence of obesity continuing to rise globally, innovative therapies like orforglipron are crucial for helping individuals achieve and maintain significant weight loss.

References:
[1] https://seekingalpha.com/news/4489112-eli-lilly-posts-phase-3-trial-win-obesity-pill
[2] https://www.ainvest.com/news/eli-lilly-orforglipron-achieves-10-5-weight-loss-phase-3-trial-2508/