*

Higher 36 mg dose of orforglipron leads to 12.4% weight

loss vs

0.9% for placebo

*

Dropout rate due to side effects was about 10% for

high-dose

patients

*

Lilly plans to file for approval of once-daily pill this

year

By Patrick Wingrove

Aug 7 (Reuters) - Eli Lilly ( LLY ) said on Thursday

that its experimental GLP-1 pill helped patients lose 12.4% of

their body weight after 72 weeks in a late-stage study, less

than previous trial results for Novo Nordisk's

injectable obesity treatment Wegovy.

Unlike injectable obesity drugs, which are peptides designed

to mimic the appetite-controlling GLP-1 hormone, orforglipron is

a small molecule pill that is easier to manufacture and package,

said Kenneth Custer, president of Lilly's cardiometabolic health

division.

Lilly, whose injectable GLP-1 Zepbound competes directly

with Wegovy, views the once-daily pill as a promising

alternative to injections that could be used for early

intervention and long-term disease management, Custer said.

"We have pretty big aspirations for how many patients

orforglipron could help," he said, adding that Lilly still

expects to file for regulatory approvals of the once-daily pill

before the end of the year.

In the over 3,000-person study of overweight or obese adults

with weight-related health issues, but not diabetes, those who

received the highest 36 milligram dose of orforglipron on

average shed 12.4% of their weight versus 0.9% for those who

received a placebo.

Patients on the 6 mg dose of the Lilly drug lost 7.8% of

their weight.

The most common side effects seen in the study were

mild-to-moderate gastrointestinal issues. The rate of nausea for

high-dose patients was 33.7%, while 24% experienced vomiting,

compared with 10.4% and 3.5%, respectively for the placebo

group.

Just over 10% of the high-dose patients dropped out of the

trial due to adverse side effects. No liver safety issues were

seen, Lilly said.

At least three analysts said the market had been looking for

orforglipron to match Wegovy's 14.9% weight loss over 68 weeks,

as shown in a 2021 trial, with some expecting the pill to

surpass Novo's popular drug.

Zepbound and Wegovy currently dominate the weight-loss

market, which some analysts expect to reach $150 billion by the

early 2030s.

The U.S. Food and Drug Administration is reviewing a

high-dose oral version of Wegovy for potential approval later

this year. Novo said it helped overweight or obese adults lose

15% of their body weight in a late-stage trial.

Custer said orforglipron can be taken without restrictions

on food and water.

Lilly said orforglipron also lowered markers of heart

disease risk, including cholesterol, triglycerides, and blood

pressure, across all doses.

Wegovy has been approved to reduce the risk of major heart

problems, and Lilly last week 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.

The company announced earlier this year that a Phase 3 study

found that type 2 diabetes patients lost nearly 8% of their body

weight after 40 weeks on orforglipron.

Lilly has also said it has begun manufacturing the drug in

order to stockpile supply ahead of a commercial launch, which

should help avoid shortages experienced when early demand for

the injectables far outstripped supply.

The full results from the Lilly-backed trial will be

presented next month at a major European diabetes meeting, the

Indianapolis-based drugmaker said.