Lilly expects orforglipron obesity results in third quarter
Lilly expects to submit the non-diabetes Phase 3 data to global regulatory agencies by the end of the year, said Ken Custer, head of cardiometabolic health at the company. The U.S. Food and Drug Administration typically makes new drug approval decisions 10 months after a manufacturer's submission.
Lilly said it plans to file for regulatory approvals for orforglipron as a diabetes treatment in 2026.
Full results of the diabetes trial were presented at the annual meeting of the American Diabetes Association in Chicago.
The Phase 3 study showed that type 2 diabetes patients taking the highest dose of daily orforglipron lost nearly 8% of their body weight over 40 weeks. That compares favorably with Novo Nordisk's (NOVOb.CO), opens new tab injected drug Ozempic, for which trials showed that diabetic patients on the highest dose lost roughly 6% of their body weight.
Lilly's pill, which can be taken without food or water, lowered blood sugar levels by an average of 1.3% to 1.6% across doses.
The company said the most frequently reported side effects were gastrointestinal and similar to other GLP-1 drugs, including diarrhea and vomiting.
Custer said Lilly's goal in its non-diabetes trials is to achieve weight loss consistent with GLP-1 drugs that are currently available. Ozempic was shown in trials to lead to weight loss of 15% for people without diabetes over 68 weeks.
He said orforglipron, which has a simpler production process than injected GLP-1 drugs such as Ozempic or Lilly's Zepbound and does not require cold storage, could mean wider global access to weight-loss drugs.
"This is the type of molecule that is going to allow us to reach the broader globe," Custer said.
The executive declined to comment on pricing plans for orforglipron.
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