Particle.news

Download on the App Store

Lilly’s Oral GLP-1 Pill Hits 72-Week Goals, Company to Seek Global Approvals

Regulatory filings will test whether an easier-to-make oral option can broaden access beyond injections.

Eli Lilly Biotechnology Center is shown in San Diego, California, U.S. March 1, 2023. REUTERS/Mike Blake/File Photo
Image
Image

Overview

  • Eli Lilly said its once-daily small-molecule GLP-1 pill, orforglipron, produced 10.5% average weight loss at 72 weeks in adults with overweight or obesity and type 2 diabetes, meeting primary and key secondary endpoints.
  • The trial lowered A1C by up to 1.8 percentage points at the highest dose, and 75% of those patients reached an A1C of 6.5% or less, which is at or below the diabetes threshold.
  • Gastrointestinal side effects were common, with nausea in 36.4%, vomiting in 23.1% and diarrhea in 27.4% at the top dose, and just over 10% discontinued due to adverse events at that dose, according to company-reported data.
  • Lilly said it now has the full data package to begin global regulatory submissions, positioning the oral pill—which has no fasting or water restrictions and is easier to manufacture than peptide injections—against rivals as Novo Nordisk pursues approval of an oral Wegovy.
  • Separately, a phase 3 study published in The Lancet found ecnoglutide matched or beat dulaglutide on glycemic control and delivered nearly double the weight loss, as consumer reports show GLP-1 use is reshaping dining habits and prompting smaller-portion offerings at restaurants.