Prnewswireยท2025-08-07 10:25Core Insights - Eli Lilly's investigational oral medication orforglipron has shown significant efficacy in weight loss and cardiovascular risk factor improvement in the Phase 3 ATTAIN-1 trial, with plans for regulatory submission by year-end [1][4][5] Efficacy Results - In the ATTAIN-1 trial, orforglipron demonstrated a mean weight reduction of 12.4% (27.3 lbs) at the highest dose (36 mg) compared to 0.9% (2.2 lbs) with placebo after 72 weeks [1][2] - Key secondary endpoints showed that 59.6% of participants on the highest dose lost at least 10% of their body weight, while 39.6% lost at least 15% [1][2] - The treatment also resulted in significant reductions in cardiovascular risk markers, including non-HDL cholesterol and systolic blood pressure [1][3] Safety Profile - The safety profile of orforglipron was consistent with existing GLP-1 receptor agonists, with gastrointestinal-related adverse events being the most common [3] - The most frequently reported adverse events included nausea (28.9% to 35.9%), constipation (21.7% to 29.8%), and diarrhea (21.0% to 23.1%) across different doses, compared to lower rates in the placebo group [3] Clinical Trial Details - The ATTAIN-1 trial involved 3,127 participants with obesity or overweight and at least one weight-related medical issue, randomized to receive either orforglipron or placebo [6][7] - The trial's primary objective was to demonstrate superior body weight reduction compared to placebo after 72 weeks [6] Future Plans - Eli Lilly plans to present detailed results from the ATTAIN-1 trial at the European Association for the Study of Diabetes Annual Meeting in 2025 and publish findings in a peer-reviewed journal [4] - Additional results from the ATTAIN Phase 3 clinical trial program and the ACHIEVE Phase 3 program for type 2 diabetes are expected later this year [4]