Aug 26 (Reuters) - Eli Lilly ( LLY ) said on Tuesday its
experimental GLP-1 pill helped overweight adults with type 2
diabetes shed 10.5% of body weight in a late-stage trial, after
recent data from another study of the drug in patients without
diabetes sent company shares tumbling.
The once-daily pill also helped 75% of patients who received
the highest dose of orforglipron lower their A1C level - a
measure of blood sugar over time - to at or below 6.5%, Lilly
said, which is below the American Diabetes Association's target
of less than 7% for most adults.
Orforglipron is a small-molecule pill that is easier to
manufacture and package than wildly popular injectable drugs for
obesity, such as Lilly's Zepbound and Novo Nordisk's
rival treatment Wegovy, which are peptide mimics of the
appetite-controlling GLP-1 hormone.
Lilly views the pill as a promising alternative to
injections that can be made at "extraordinary scale," said
Kenneth Custer, president of the cardiometabolic health division
for the Indianapolis-based drugmaker.
In the 72-week study of more than 1,600 overweight or obese
adults with type 2 diabetes, those who received the 36-milligram
highest dose of orforglipron on average shed 10.5% of their
weight, or about 23 pounds (10.43 kg), versus 2.2% for those who
received a placebo, achieving the main goal of the trial.
Patients on the lowest 6 mg dose of the Lilly drug lost 5.5%
of their weight.
Custer said overweight and obese patients with type 2
diabetes are typically more resistant to weight loss than those
without the condition.
With data from this trial in hand, Lilly said it now has the
full clinical package needed to start filing for approvals of
orforglipron with various regulators.
When asked if Lilly would consider seeking a priority review
voucher, which can cut the FDA's decision time for a new drug
application to six months from the standard 10, Custer said "all
options are on the table."
Topline data from orforglipron's earlier late-stage study in
overweight or obese adults without diabetes showed 12.4% average
weight loss. Analysts had hoped it would match Wegovy's 14.9%
over 68 weeks from 2021, with some expecting the pill to exceed
that.
The rate of nausea in the latest trial for high-dose
patients was 36.4%, while 23.1% experienced vomiting, compared
with 8.4% and 3.8%, respectively, for the placebo group. That
was similar to the earlier study's 33.7% nausea and 24% vomiting
rates, which contributed to the share selloff.
In the latest results, just over 10% of the high-dose
patients dropped out of the trial due to adverse side effects.
As with the prior trial, no liver safety issues were seen, Lilly
said.
Zepbound and Wegovy dominate a weight-loss market that is
projected by some analysts to generate $150 billion a year by
the early 2030s.
The U.S. Food and Drug Administration is reviewing a
high-dose oral Wegovy for possible approval this year. Novo says
it delivered 15% weight loss in a late-stage trial.
Lilly said the latest trial also showed orforglipron
improved heart-risk markers, lowering cholesterol,
triglycerides, and blood pressure, across all doses.
Wegovy has been approved to reduce the risk of major heart
problems, and Lilly this month released data showing the
heart-protective qualities of diabetes treatment Mounjaro, which
has the same main ingredient as Zepbound.
Heart disease approvals would greatly enhance the likelihood
of insurance coverage for weight-loss drugs.