*
Weight-loss with Lilly's GLP-1 pill plateaus for most
patients
*
Orforglipron improves cardiovascular risk factors, reduces
inflammation marker by 47.7%
*
High-dose orforglipron group sees 10.3% dropout due to
side
effects
By Deena Beasley
Sept 16 (Reuters) - Eli Lilly's ( LLY ) experimental
GLP-1 pill helped people lose about 12% of their body weight,
with weight loss plateauing for most patients in the 72-week
trial, according to full study results presented at a medical
meeting on Tuesday.
Lilly had announced in August that the Phase 3 study of the
daily pill, orforglipron, met its main goals, but the weight
loss was less robust than previous trial results for Novo
Nordisk's weekly injectable GLP-1 drug Wegovy.
That news sent Lilly's shares down 14%. Year-to-date, the
company's shares have fallen about 1%.
Results from a late-stage study of the drug orforglipron
were presented at a European medical meeting and published in
the New England Journal of Medicine. The trial enrolled over
3,000 non-diabetic participants who were obese or overweight
with a weight-related health problem.
Lilly said orforglipron showed clinically meaningful
improvements across key cardiovascular risk factors, including
cholesterol levels and blood pressure. It said the highest dose
of the drug reduced a key marker of inflammation by 47.7%.
The most commonly reported side effects were
mild-to-moderate and gastrointestinal. The rate of nausea for
high-dose patients was 33.7%, compared with 10.4% for placebo
patients.
In the high-dose orforglipron group, 10.3% of patients
dropped out of the trial due to side effects, compared with 2.6%
of placebo patients.
Lilly said liver safety was thoroughly evaluated and
concluded that there was no concerning pattern of liver issues
among patients taking the drug. High liver enzyme levels were
reported in seven orforglipron patients, but alternative causes
were identified, researchers said.
During the 72-week trial, three deaths were reported: one
low-dose orforglipron patient, one mid-dose patient and one
placebo patient.
Five cases of mild pancreatitis occurred in orforglipron
patients. No cases of medullary thyroid cancer were reported.
An increase in the mean pulse rate of 4.3 to 5.3 beats per
minute occurred in the orforglipron groups, compared with an
increase of 0.8 beat per minute in the placebo group, which
researchers said was consistent with findings observed with
injected GLP-1 drugs.
In a previous 36-week Phase 2 trial, orforglipron was shown
to reduce body weight by nearly 15% without an apparent plateau.
Researchers said that despite the recent study's 72-week
duration, weight reduction was not greater, which could be due
to differences in trial design, including more geographic
diversity and a higher percentage of men.