Eli Lilly's Orforglipron Achieves 10.5% Weight Loss in Phase 3 Trial

Eli Lilly and Company (LLY.US) has announced that its oral weight loss drug, orforglipron, has achieved its primary endpoint in the Phase 3 ATTAIN-2 trial. The drug demonstrated an average weight loss of 10.5% over 72 weeks at the highest dose. This significant result has prompted the company to initiate global regulatory submissions for the drug.

The Phase 3 trial, known as ATTAIN-2, was designed to evaluate the efficacy and safety of orforglipron in participants with obesity or overweight with at least one weight-related comorbidity. The trial enrolled over 1,600 participants, and the results showed that orforglipron, when used in combination with a reduced-calorie diet and increased physical activity, led to substantial weight loss.

The primary endpoint of the trial was the percentage change in body weight from baseline to week 72. Participants who received the highest dose of orforglipron achieved an average weight loss of 22.9 pounds, or 10.5% of their initial body weight. This result is particularly noteworthy as it exceeds the weight loss observed in previous trials of other weight loss medications.

The safety profile of orforglipron was also evaluated in the trial. The most common adverse events reported were gastrointestinal in nature, including nausea, diarrhea, and constipation. These side effects were generally mild to moderate in severity and resolved over time. The overall safety profile of orforglipron was considered acceptable, with no new safety signals identified.

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. If approved, orforglipron has the potential to 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 highlights the ongoing efforts of pharmaceutical companies to develop effective and safe treatments for obesity. With the prevalence of obesity continuing to rise globally, there is a growing need for innovative therapies that can help individuals achieve and maintain significant weight loss. Orforglipron's ability to deliver substantial weight loss in a clinical trial setting is a promising development in this area.