Eli Lilly’s experimental oral GLP-1 medication, orforglipron, led to an average weight loss of 12.4%, or 27.3 pounds, in a phase 3 trial involving more than 3,000 adults.
Based on the results, the drugmaker said Aug. 7 it plans to submit orforglipron to regulatory agencies by the end of 2025. Eli Lilly’s CEO has previously said the company aims to gain FDA approval by early 2026.
The most common GLP-1 formulation is injectable. In May, Novo Nordisk filed an application for its oral version of Wegovy (semaglutide). If approved, the drug would be the first GLP-1 pill for weight loss.
The 72-week study assessed weight loss among 3,127 adults with obesity or who are overweight with a weight-related medical problem. Compared to a placebo, which resulted in an average weight loss of 2.2 pounds, a 36-milligram dose of orforglipron reduced weight by an average of 27.3 pounds.
Nearly 55% of study participants taking the 36-milligram dose experienced at least 10% weight loss, and 36% lost 15% or more of their body weight.
Beyond weight loss, the daily pill was associated with reduced cardiovascular risk, Eli Lilly said.
The most common side effects were nausea, constipation, diarrhea, vomiting and dyspepsia. About 20% of trial participants taking the drug candidate discontinued treatment, compared to 29.9% in the placebo group. Eli Lilly is also studying the pill’s efficacy in patients with Type 2 diabetes.
