June 21 (Reuters) - Eli Lilly ( LLY ) said on Saturday
its experimental pill orforglipron helped diabetics lose weight
and lower their blood sugar, and the company aims to announce in
the third quarter trial results for the drug in overweight and
obese people without diabetes.
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 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.