Eli Lilly Announces Positive Results from Phase 3 Trial of Obesity Treatment Drug Orforglipron.

Eli Lilly has announced positive topline results from the Phase 3 ATTAIN-1 trial of orforglipron, an oral GLP-1 receptor agonist, for treating obesity. All three doses met the primary and key secondary endpoints, delivering clinically meaningful weight loss as an adjunct to a healthy diet and physical activity. Detailed results will be presented at the EASD Annual Meeting 2025 and published in a peer-reviewed journal.

Eli Lilly and Company (NYSE: LLY) has announced positive topline results from the Phase 3 ATTAIN-1 trial of orforglipron, an investigational oral glucagon-like peptide-1 (GLP-1) receptor agonist. The trial evaluated the efficacy and safety of orforglipron in 3,127 adults with obesity or overweight with a weight-related medical problem and without diabetes. The results demonstrate significant weight loss and improvements in cardiovascular risk factors.

At 72 weeks, all three doses of orforglipron met the primary endpoint and all key secondary endpoints compared to placebo. The highest dose (36 mg) resulted in an average weight loss of 27.3 lbs (12.4%) compared to 0.9% (2.2 lbs) with placebo. Additionally, 59.6% of participants taking the highest dose lost at least 10% of their body weight, while 39.6% lost at least 15%. The trial also showed reductions in non-HDL cholesterol, triglycerides, and systolic blood pressure.

The overall safety profile of orforglipron was consistent with the established GLP-1 receptor agonist class. The most common adverse events were gastrointestinal-related and generally mild to moderate in severity. Treatment discontinuation rates due to adverse events were 5.1% (6 mg), 7.7% (12 mg), and 10.3% (36 mg) for orforglipron versus 2.6% with placebo.

Lilly plans to submit orforglipron for regulatory review by year-end and is preparing for a global launch to address the urgent public health need of obesity. The detailed ATTAIN-1 results will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2025 and published in a peer-reviewed journal.

References:
[1] https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-delivers-weight-loss-average-273