Lilly's Orforglipron Achieves Significant Weight Loss In Phase 3 Trial

(RTTNews) - Eli Lilly and Co. (LLY) announced detailed results from its Phase 3 ATTAIN-1 trial, evaluating the safety and efficacy of orforglipron—an investigational oral glucagon-like peptide-1 (GLP-1) receptor agonist—in adults with obesity, or those overweight with a weight-related medical condition and without diabetes. At 72 weeks, all three doses (6 mg, 12 mg, and 36 mg) of orforglipron met the primary endpoint, demonstrating superior body weight reduction compared to placebo. Additionally, each dose delivered clinically meaningful results across key secondary endpoints, including body weight reductions of =10%, =15%, and =20%, as well as reductions in waist circumference.

According to the company, the investigational once-daily oral pill led to an average weight loss of 27.3 lbs (12.4%) at the highest dose by week 72 in the Phase 3 study. As a result, orforglipron met its primary endpoint, demonstrating superior body weight reduction compared to placebo.

In key secondary endpoints, 59.6% of participants taking the highest dose of orforglipron lost at least 10% of their body weight, while 39.6% lost at least 15% of their body weight. Among the 1,127 participants who had prediabetes at the start of the study, up to 91% of those taking orforglipron achieved near-normal blood sugar levels compared to 42% of those taking placebo at 72 weeks.

Additionally, orforglipron showed clinically meaningful improvements across key cardiovascular risk factors often associated with obesity, including non-HDL cholesterol, systolic blood pressure and triglycerides. In a pre-specified exploratory analysis, the highest dose of orforglipron reduced high-sensitivity C-reactive protein (hsCRP) levels, a marker of inflammation, by 47.7%.

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