Eli Lilly’s weight loss drug Zepbound shows promise as a sleep apnea treatment in late-stage trials

Eli
Lilly
on
Wednesday
said
its
highly
popular
weight
loss
drug

Zepbound
showed
the
potential
to
treat
patients
with
the
most
common

sleep-related
breathing
disorder
in
two
late-stage
clinical
trials.

The
initial
results
add
to
the
long
list
of

potential
health
benefits
of
weight
loss
and
diabetes
treatments,
which
have
skyrocketed
in
demand
over
the
last
year
despite
their
high
prices
and
spotty
insurance
coverage.

Zepbound
was
more
effective
than
a
placebo
at
reducing
the
severity
of

obstructive
sleep
apnea,
or
OSA,
in
patients
with
obesity
after
a
year,
according
to
preliminary
data
from
both
trials.
The
pharmaceutical
giant
said
it
plans
to
present
the
results
at
an
upcoming
medical
conference
and
submit
it
to
the
U.S.
Food
and
Drug
Administration
and
regulators
in
other
countries
in
the
middle
of
the
year.

Eli
Lilly
previously
announced
that
the
FDA
granted
Zepbound
“fast
track
designation”
for
patients
with
moderate-to-severe
OSA
and
obesity.
That
designation
expedites
the
review
of
drugs
that
treat
a
serious
or
life-threatening
condition
and
fill
an
unmet
medical
need. 

The
results
are
an
early
sign
of
hope
for
the
estimated
80
million
patients
in
the
U.S.
suffering
from
OSA,
which
refers
to
interrupted
breathing
during
sleep
due
to
narrowed
or
blocked
airways.
Around
20
million
of
those
people
have
moderate-to-severe
forms
of
the
disease,
but
85%
of
OSA
cases
go
undiagnosed,
according
to
Eli
Lilly.

OSA
can
lead
to

excessive
daytime
sleepiness,
loud
snoring
and
can
contribute
to
serious
complications,
including
hypertension,
stroke
and
heart
failure.
Patients
with
the
condition
have
limited
treatment
options
outside
of
cumbersome
and
often
uncomfortable

machines
that
provide
positive
airway
pressure,
or
PAP,
to
allow
for
normal
breathing.

“Addressing
this
unmet
need
head-on
is
critical,
and
while
there
are
pharmaceutical
treatments
for
the
excessive
sleepiness
associated
with
OSA,
[Zepbound]
has
the
potential
to
be
the
first
pharmaceutical
treatment
for
the
underlying
disease,”
Dr.
Jeff
Emmick,
Eli
Lilly’s
senior
vice
president
of
product
development,
said
in
a
release
on
Wednesday.

Zepbound
has
slipped
into
shortages
since

receiving
approval
in
the
U.S.
for
weight
management
in
November. The
active
ingredient
in
Zepbound,
known
as
tirzepatide,
is
also
approved
under
the
brand
name
Mounjaro
for
diabetes.

The
two
phase
three
trials,
both
called
SURMOUNT-OSA,
tested
Zepbound
in
two
groups
of
patients. Notably,
70%
of
participants
across
the
studies
were
men.

Researchers
specifically
examined
how
much
the
weekly
injection
reduced
the
so-called

apnea-hypopnea
index,
or
AHI,
which
records
the
number
of
times
per
hour
a
person’s
breathing
shows
a
restricted
or
completely
blocked
airway.
The
index
is
used
to
evaluate
the
severity
of
obstructive
sleep
apnea
and
the
effectiveness
of
treatments
for
the
condition. 

In
both
sub-studies,
Zepbound
was
superior
to
placebo
in
reducing
AHI,
which
was
the
main
goal
of
the
trials.

The
first
study
evaluated
the
drug
in
adults
with
moderate
to
severe
obstructive
sleep
apnea
and
obesity
who
were
not
on
PAP
therapy.

Zepbound
led
to
an
average
AHI
reduction
of
25.3
events
per
hour
at
52
weeks,
regardless
of
whether
a
patient
discontinued
the
treatment.
That
compares
to
an
average
reduction
of
5.3
events
per
hour
for
the
placebo. 

Zepbound
also
met
the
trial’s
second
goal,
leading
to
an
overall
AHI
reduction
of
more
than
50%
compared
to
a
decrease
of
3% for
the
placebo.
That
data
included
patients
who
discontinued
the
treatment.

The
second
study
tested
Zepbound
in
adults
with
the
same
conditions,
but
those
patients
were
on
and
planned
on
continuing
PAP
therapy.

Eli
Lilly’s
drug
led
to
an
average
AHI
reduction
of
29.3
events
per
hour
at
52
weeks,
regardless
of
whether
a
patient
discontinued
the
treatment.
That
compares
to
an
average
reduction
of
5.5
events
per
hour
for
the
placebo. 

Zepbound
led
to
an
overall
AHI
reduction
of
nearly
59%
compared
to
a
decrease
of
more
than
2% for
the
placebo,
which
included
data
in
patients
who
discontinued
the
treatment.

Across
the
two
studies,
Zepbound
helped
patients
lose
around
20%
of
their
weight.
But
Eli
Lilly
noted
that
men
are
known
to
achieve
less
weight
loss
than
women
with
therapies
like
Zepbound.

Eli
Lilly’s
Zepbound
works
by
imitating
two
naturally
produced
gut
hormones
called
GLP-1
and
GIP.
GLP
helps
reduce
food
intake
and
appetite.
GIP,
which
also
suppresses
appetite,
may
also
improve
how
the
body
breaks
down
sugar
and
fat.

Notably,
Eli
Lilly’s
main
rival


Novo
Nordisk
is
no
studying
its
own
weight
loss
and
diabetes
drugs
in
patients
with
sleep
apnea.