Eli Lilly Says Phase 3 Study of Orforglipron Meets Primary Endpoint

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Eli Lilly (LLY) said Tuesday that a phase 3 study of orforglipron met its primary endpoint, with all three doses of orforglipron demonstrating "superior body weight reduction" compared with placebo.

Orforglipron is the company's investigational oral glucagon-like peptide-1, or GLP-1, receptor agonist and the phase 3 study enrolled adults with obesity, or overweight, with a weight-related medical problem and without diabetes, according to the statement.

Eli Lilly said all three orforglipron doses also delivered clinically meaningful results across key secondary endpoints of body weight reduction and waist circumference reduction. The investigational drug also demonstrated improvements in key cardiovascular risk factors associated with obesity, the company added.

Eli Lilly said it plans to proceed with orforglipron's global regulatory submissions as obesity treatment, with regulatory action expected as soon as next year. Regulatory submission for the treatment of type 2 diabetes is expected in 2026, the company said.

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