In the primary endpoint, tirzepatide
reduced moderate-to-severe OSA severity by up to 62.8% (about 30
fewer events per hour)
In a key secondary endpoint from two clinical
studies, 43.0% and 51.5% of participants taking tirzepatide at the
highest dose reached the criteria for disease resolution as defined
by apnea-hypopnea index and Epworth Sleepiness Scale
measures
Lilly submitted tirzepatide for the treatment
of moderate-to-severe OSA and obesity to the U.S. Food and Drug
Administration (FDA) and will initiate submissions for other global
regulatory agencies in the coming weeks
INDIANAPOLIS, June 21,
2024 /PRNewswire/ -- Eli Lilly and Company (NYSE:
LLY) announced detailed results from the SURMOUNT-OSA phase 3
clinical trials evaluating tirzepatide injection (10 mg or 15 mg)
for the treatment of moderate-to-severe obstructive sleep apnea
(OSA) in adults with obesity, with and without positive airway
pressure (PAP) therapy. In both studies, tirzepatide achieved all
primary and key secondary endpoints for both the
efficacyi and treatment-regimenii estimands
and demonstrated a mean reduction of up to 62.8% on the
apnea-hypopnea index (AHI), or about 30 fewer events restricting or
blocking a person's airflow per hour of sleep, compared to placebo.
Full results were published in The New England Journal of
Medicine (NEJM) and presented at the American Diabetes
Association® (ADA) 84th Scientific
Sessions.
In a key secondary endpoint, the efficacy estimand showed that
43.0% (Study 1) and 51.5% (Study 2) of participants treated with
tirzepatide at the highest dose met the criteria for disease
resolution. In this context, "disease resolution" means achieving
an AHI of fewer than 5 events per hour, or an AHI of 5-14 events
per hour and an Epworth Sleepiness Scale (ESS) score of ≤10. ESS is
a standard questionnaire designed to assess excessive daytime
sleepiness.1-4
OSA is a complex disease that can impact the progression of
serious cardiometabolic complications, including hypertension,
coronary heart disease, stroke, heart failure, atrial fibrillation
and type 2 diabetes.5 Participants treated with
tirzepatide in both studies experienced significant improvements in
all key secondary endpoints including systolic blood pressure,
hypoxic burden and high-sensitivity C-reactive protein (hsCRP), an
inflammation marker, compared to placebo.
"In the trials, patients with moderate-to-severe obstructive
sleep apnea and obesity treated with tirzepatide experienced about
30 fewer disruptive events every hour of sleep and nearly half
achieved disease resolution," said Atul
Malhotra, MD, Peter C.
Farrell presidential chair, professor of medicine at
University of California San Diego
School of Medicine and director of sleep medicine at UC San Diego
Health. "OSA can be very disruptive to daily life and affects a
person's long-term health when left untreated because it can lead
to serious cardiometabolic complications. These data support the
efficacy of tirzepatide in adults living with moderate-to-severe
OSA and obesity and has the potential to add to our toolbox for OSA
treatment."
Full
Results:
|
|
SURMOUNT-OSA Study 1
– Participants Not on PAP Therapy
|
|
Efficacy Estimand
Results
at 52 Weeks
|
Treatment-Regimen
Estimand
Results at 52
Weeks
|
Primary Endpoint –
Change in AHI from Baseline
|
Tirzepatide*
|
-27.4
|
-25.3
|
Placebo
|
-4.8
|
-5.3
|
Secondary Endpoint –
Percent Change in AHI from Baseline
|
Tirzepatide*
|
-55.0 %
|
-50.7 %
|
Placebo
|
-5.0 %
|
-3.0 %
|
Secondary Endpoint –
Percentage of Participants with AHI <5 or AHI 5-14 with ESS
≤10
|
Tirzepatide*
|
43.0 %
|
42.2 %
|
Placebo
|
14.9 %
|
15.9 %
|
Secondary Endpoint –
Percentage of Participants with ≥50% AHI Reduction
|
Tirzepatide*
|
62.3 %
|
61.2 %
|
Placebo
|
19.2 %
|
19.0 %
|
Secondary Endpoint –
Percent Change in Body Weight
|
Tirzepatide*
|
-18.1 %
|
-17.7 %
|
Placebo
|
-1.3 %
|
-1.6 %
|
|
SURMOUNT-OSA Study
2 – Participants Used PAP Therapy
|
|
Efficacy Estimand
Results
at 52 Weeks
|
Treatment-Regimen
Estimand
Results at 52
Weeks
|
Primary Endpoint –
Change in AHI from Baseline
|
Tirzepatide*
|
-30.4
|
-29.3
|
Placebo
|
-6.0
|
-5.5
|
Secondary Endpoint –
Percent Change in AHI from Baseline
|
Tirzepatide*
|
-62.8 %
|
-58.7 %
|
Placebo
|
-6.4 %
|
-2.5 %
|
Secondary Endpoint –
Percentage of Participants with AHI <5 or AHI 5-14 with ESS
≤10
|
Tirzepatide*
|
51.5 %
|
50.2 %
|
Placebo
|
13.6 %
|
14.3 %
|
Secondary Endpoint –
Percentage of Participants with ≥50% AHI Reduction
|
Tirzepatide*
|
74.3 %
|
72.4 %
|
Placebo
|
22.9 %
|
23.3 %
|
Secondary Endpoint –
Percent Change in Body Weight
|
Tirzepatide*
|
-20.1 %
|
-19.6 %
|
Placebo
|
-2.3 %
|
-2.3 %
|
*For both
SURMOUNT-OSA Study 1 and Study 2, tirzepatide MTD is maximum
tolerated dose of 10 mg or 15 mg once-weekly. The starting dose of
2.5 mg tirzepatide was increased by 2.5 mg every four weeks until
maximum tolerated dose was achieved. Participants who tolerated 15
mg continued on 15 mg as their maximum tolerated dose. Participants
who tolerated 10 mg but did not tolerate 15 mg continued on 10 mg
as their maximum tolerated dose.
|
"There are currently no pharmaceutical treatment options to
address the underlying cause of OSA, a complex disease that
disrupts the daily lives of 80 million people in the U.S. alone and
is linked to serious health complications," said Jeff Emmick, MD, Ph.D., senior vice president,
product development, Lilly. "The SURMOUNT-OSA results showed a
significant proportion of patients with moderate-to-severe OSA and
obesity treated with tirzepatide achieved disease resolution based
on predetermined AHI and ESS measures, at which point PAP therapy
may not be recommended." 4-9
The overall safety profile of tirzepatide in SURMOUNT-OSA
studies was similar to previously reported SURMOUNT and SURPASS
trials. The most commonly reported adverse events in SURMOUNT-OSA
were gastrointestinal related and generally mild to moderate in
severity. The most frequent events reported by those on tirzepatide
compared with placebo, respectively, were diarrhea (26.3% vs
12.5%), nausea (25.4% vs 10.0%) and vomiting (17.5% vs 4.2%) in
SURMOUNT-OSA Study 1, and diarrhea (21.8% vs 8.8%), nausea (21.8%
vs 5.3%) and constipation (15.1% vs 4.4%) in SURMOUNT-OSA Study 2.
Adverse events led to discontinuation of study treatment in 9
participants taking tirzepatide (5 in Study 1 and 4 in Study 2) and
10 taking placebo (2 in Study 1 and 8 in Study 2).
Tirzepatide is the only approved GIP (glucose-dependent
insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1)
treatment for chronic weight management, commercialized as
Zepbound® in the U.S. and Mounjaro® in some
global markets outside the U.S. Lilly submitted tirzepatide
for the treatment of moderate-to-severe OSA and obesity to the U.S.
Food and Drug Administration (FDA) with regulatory action
anticipated as early as the end of this year. Lilly received FDA
Fast Track designation for moderate-to-severe OSA in patients with
obesity.
About SURMOUNT-OSA
SURMOUNT-OSA (NCT05412004) was a multi-center, randomized,
double-blind, parallel, placebo-master protocol comparing the
efficacy and safety of tirzepatide to placebo in adults living with
moderate-to-severe obstructive sleep apnea and obesity who were
unable or unwilling to use positive airway pressure (PAP) therapy
(Study 1) and those who were and planned to stay on PAP therapy
during the duration of the trial (Study 2). Under a master
protocol, the trials randomized 469 participants across the U.S.,
Australia, Brazil, China, Czechia, Germany, Japan, Mexico
and Taiwan in a 1:1 ratio to
receive tirzepatide maximum tolerated dose (MTD) 10 mg or 15 mg or
placebo. The primary objective of both studies was to demonstrate
that tirzepatide is superior in change in apnea-hypopnea index
(AHI) from baseline at 52 weeks as compared to placebo.
SURMOUNT-OSA utilized a MTD of 10 mg or 15 mg once-weekly. The
starting dose of 2.5 mg tirzepatide was increased by 2.5 mg every
four weeks until maximum tolerated dose was achieved. Participants
who tolerated 15 mg continued on 15 mg as their MTD. Participants
who tolerated 10 mg but did not tolerate 15 mg continued on 10 mg
as their MTD.
INDICATION AND SAFETY SUMMARY WITH
WARNINGS
Zepbound® (ZEHP-bownd) is an injectable
prescription medicine that may help adults with obesity, or with
excess weight (overweight) who also have weight-related medical
problems, lose weight and keep it off. It should be used with a
reduced-calorie diet and increased physical activity.
- Zepbound contains tirzepatide and should not be used with other
tirzepatide-containing products or any GLP-1 receptor agonist
medicines. It is not known if Zepbound is safe and effective when
taken with other prescription, over-the-counter, or herbal weight
loss products. It is not known if Zepbound can be used in people
who have had pancreatitis. It is not known if Zepbound is safe and
effective for use in children under 18 years of age.
Warnings - Zepbound may cause tumors in the thyroid,
including thyroid cancer. Watch for possible symptoms, such as a
lump or swelling in the neck, hoarseness, trouble swallowing, or
shortness of breath. If you have any of these symptoms, tell your
healthcare provider.
- Do not use Zepbound if you or any of your family have ever had
a type of thyroid cancer called medullary thyroid carcinoma
(MTC).
- Do not use Zepbound if you have Multiple Endocrine Neoplasia
syndrome type 2 (MEN 2).
- Do not use Zepbound if you have had a serious allergic reaction
to tirzepatide or any of the ingredients in Zepbound.
Zepbound may cause serious side effects,
including:
Severe stomach problems. Stomach
problems, sometimes severe, have been reported in people who use
Zepbound. Tell your healthcare provider if you have stomach
problems that are severe or will not go away.
Kidney problems (kidney failure). Diarrhea, nausea, and
vomiting may cause a loss of fluids (dehydration), which may cause
kidney problems. It is important for you to drink fluids to help
reduce your chance of dehydration.
Gallbladder problems. Gallbladder problems have
happened in some people who use Zepbound. Tell your healthcare
provider right away if you get symptoms of gallbladder problems,
which may include pain in your upper stomach (abdomen), fever,
yellowing of skin or eyes (jaundice), or clay-colored stools.
Inflammation of the pancreas (pancreatitis). Stop
using Zepbound and call your healthcare provider right away if you
have severe pain in your stomach area (abdomen) that will not go
away, with or without vomiting. You may feel the pain from your
abdomen to your back.
Serious allergic reactions. Stop using Zepbound and
get medical help right away if you have any symptoms of a serious
allergic reaction, including swelling of your face, lips, tongue or
throat, problems breathing or swallowing, severe rash or itching,
fainting or feeling dizzy, or very rapid heartbeat.
Low blood sugar (hypoglycemia). Your risk for
getting low blood sugar may be higher if you use Zepbound with
medicines that can cause low blood sugar, such as a sulfonylurea or
insulin. Signs and symptoms of low blood sugar may
include dizziness or light-headedness, sweating, confusion
or drowsiness, headache, blurred vision, slurred speech, shakiness,
fast heartbeat, anxiety, irritability, mood changes, hunger,
weakness or feeling jittery.
Changes in vision in patients with type 2
diabetes. Tell your healthcare provider if you have
changes in vision during treatment with Zepbound.
Depression or thoughts of suicide. You should pay
attention to changes in your mood, behaviors, feelings or thoughts.
Call your healthcare provider right away if you have any mental
changes that are new, worse, or worry you.
Common side effects
The most common side effects of
Zepbound include nausea, diarrhea, vomiting, constipation, stomach
(abdominal) pain, indigestion, injection site reactions, feeling
tired, allergic reactions, belching, hair
loss, and heartburn. These are not all the
possible side effects of Zepbound. Talk to your healthcare provider
about any side effect that bothers you or doesn't go away.
Tell your healthcare provider if you have any side
effects. You can report side effects at 1-800-FDA-1088
or www.fda.gov/medwatch.
Before using Zepbound
- Your healthcare provider should show you how to use Zepbound
before you use it for the first time.
- Tell your healthcare provider if you are taking medicines to
treat diabetes including insulin or sulfonylureas which could
increase your risk of low blood sugar. Talk to your healthcare
provider about low blood sugar levels and how to manage
them.
- If you take birth control pills by mouth, talk to your
healthcare provider before you use Zepbound. Birth control pills
may not work as well while using Zepbound. Your healthcare
provider may recommend another type of birth control for 4 weeks
after you start Zepbound and for 4 weeks after each increase in
your dose of Zepbound.
Review these questions with your healthcare provider:
❑ Do you have other medical conditions, including problems
with your pancreas or kidneys, or severe problems with your
stomach, such as slowed emptying of your stomach (gastroparesis) or
problems digesting food?
❑ Do you take diabetes medicines, such as insulin or
sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Do you take any other prescription medicines or
over-the-counter drugs, vitamins, or herbal supplements?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or
plan to breastfeed? Zepbound may harm your unborn baby. Tell your
healthcare provider if you become pregnant while using Zepbound. It
is not known if Zepbound passes into your breast milk. You should
talk with your healthcare provider about the best way to feed your
baby while using Zepbound.
- Pregnancy Exposure Registry: There will be a
pregnancy exposure registry for women who have taken Zepbound
during pregnancy. The purpose of this registry is to collect
information about the health of you and your baby. Talk to your
healthcare provider about how you can take part in this
registry.
How to take
- Read the Instructions for Use that come with
Zepbound.
- Use Zepbound exactly as your healthcare provider says.
- Zepbound is injected under the skin (subcutaneously) of your
stomach (abdomen), thigh, or upper arm.
- Use Zepbound 1 time each week, at any time of the
day.
- Change (rotate) your injection site with each weekly
injection. Do not use the same site for each
injection.
- If you take too much Zepbound, call your healthcare provider,
seek medical advice promptly, or contact a Poison Center expert
right away at 18002221222.
Learn more
Zepbound is a prescription medicine. For
more information, go to www.zepbound.lilly.com.
This summary provides basic information about Zepbound but does
not include all information known about this medicine. Read the
information that comes with your prescription each time your
prescription is filled. This information does not take the place of
talking with your healthcare provider. Be sure to talk to your
healthcare provider about Zepbound and how to take it. Your
healthcare provider is the best person to help you decide if
Zepbound is right for you.
ZP CON CBS 08NOV2023
Zepbound ® and its
delivery device base are trademarks owned or licensed by Eli
Lilly and Company, its subsidiaries, or affiliates.
INDICATION AND SAFETY SUMMARY WITH
WARNINGS
Mounjaro® (mown-JAHR-OH) is an
injectable medicine for adults with type 2 diabetes used along with
diet and exercise to improve blood sugar (glucose).
- It is not known if Mounjaro can be used in people who have had
inflammation of the pancreas (pancreatitis). Mounjaro is not for
use in people with type 1 diabetes. It is not known if Mounjaro is
safe and effective for use in children under 18 years of age.
Warnings - Mounjaro may cause tumors in the thyroid,
including thyroid cancer. Watch for possible symptoms, such as a
lump or swelling in the neck, hoarseness, trouble swallowing, or
shortness of breath. If you have any of these symptoms, tell your
healthcare provider.
- Do not use Mounjaro if you or any of your family have ever had
a type of thyroid cancer called medullary thyroid carcinoma
(MTC).
- Do not use Mounjaro if you have Multiple Endocrine Neoplasia
syndrome type 2 (MEN 2).
- Do not use Mounjaro if you are allergic to it or any of the
ingredients in Mounjaro.
Mounjaro may cause serious side effects,
including:
Inflammation of the pancreas
(pancreatitis). Stop using Mounjaro and call your
healthcare provider right away if you have severe pain in your
stomach area (abdomen) that will not go away, with or without
vomiting. You may feel the pain from your abdomen to your back.
Low blood sugar (hypoglycemia). Your risk for
getting low blood sugar may be higher if you use Mounjaro with
another medicine that can cause low blood sugar, such as a
sulfonylurea or insulin. Signs and symptoms of low blood
sugar may include dizziness or light-headedness,
sweating, confusion or drowsiness, headache, blurred vision,
slurred speech, shakiness, fast heartbeat, anxiety, irritability,
or mood changes, hunger, weakness and feeling jittery.
Serious allergic reactions. Stop using Mounjaro and
get medical help right away if you have any symptoms of a serious
allergic reaction, including swelling of your face, lips, tongue or
throat, problems breathing or swallowing, severe rash or itching,
fainting or feeling dizzy, and very rapid heartbeat.
Kidney problems (kidney failure). In people who have
kidney problems, diarrhea, nausea, and vomiting may cause a loss of
fluids (dehydration), which may cause kidney problems to get worse.
It is important for you to drink fluids to help reduce your chance
of dehydration.
Severe stomach problems. Stomach problems, sometimes
severe, have been reported in people who use Mounjaro. Tell your
healthcare provider if you have stomach problems that are severe or
will not go away.
Changes in vision. Tell your healthcare provider if
you have changes in vision during treatment with Mounjaro.
Gallbladder problems. Gallbladder problems have
happened in some people who use Mounjaro. Tell your healthcare
provider right away if you get symptoms of gallbladder problems,
which may include pain in your upper stomach (abdomen), fever,
yellowing of skin or eyes (jaundice), and clay-colored stools.
Common side effects
The most common side effects of
Mounjaro include nausea, diarrhea, decreased appetite, vomiting,
constipation, indigestion, and stomach (abdominal) pain. These are
not all the possible side effects of Mounjaro. Talk to your
healthcare provider about any side effect that bothers you or
doesn't go away.
Tell your healthcare provider if you have any side
effects. You can report side effects at 1-800-FDA-1088
or www.fda.gov/medwatch.
Before using Mounjaro
- Your healthcare provider should show you how to use Mounjaro
before you use it for the first time.
- Talk to your healthcare provider about low blood sugar and
how to manage it.
- If you take birth control pills by mouth, talk to your
healthcare provider before you use Mounjaro. Birth control pills
may not work as well while using Mounjaro. Your healthcare
provider may recommend another type of birth control for 4 weeks
after you start Mounjaro and for 4 weeks after each increase in
your dose of Mounjaro.
Review these questions with your healthcare provider:
❑ Do you have other medical conditions, including problems
with your pancreas or kidneys, or severe problems with your
stomach, such as slowed emptying of your stomach (gastroparesis) or
problems digesting food?
❑ Do you take other diabetes medicines, such as insulin or
sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or
plan to breastfeed? It is not known if Mounjaro will harm your
unborn baby or pass into your breast milk.
❑ Do you take any other prescription medicines or
over-the-counter drugs, vitamins, or herbal supplements?
How to take
- Read the Instructions for Use that come with
Mounjaro.
- Use Mounjaro exactly as your healthcare provider says.
- Mounjaro is injected under the skin (subcutaneously) of your
stomach (abdomen), thigh, or upper arm.
- Use Mounjaro 1 time each week, at any time of the
day.
- Do not mix insulin and Mounjaro together in the
same injection.
- You may give an injection of Mounjaro and insulin in the same
body area (such as your stomach area), but not right next to each
other.
- Change (rotate) your injection site with each weekly
injection. Do not use the same site for each
injection.
- If you take too much Mounjaro, call your healthcare provider or
seek medical advice promptly.
Learn more
Mounjaro is a prescription medicine. For
more information, call 1-833-807-MJRO (833-807-6576) or go
to www.mounjaro.com.
This summary provides basic information about Mounjaro but does
not include all information known about this medicine. Read the
information that comes with your prescription each time your
prescription is filled. This information does not take the place of
talking with your healthcare provider. Be sure to talk to your
healthcare provider about Mounjaro and how to take it. Your
healthcare provider is the best person to help you decide if
Mounjaro is right for you.
TR CON CBS
14SEP2022
Mounjaro® and its delivery device
base are registered trademarks owned or licensed by Eli Lilly
and Company, its subsidiaries, or affiliates.
About Lilly
Lilly is a medicine company turning science into healing to make
life better for people around the world. We've been pioneering
life-changing discoveries for nearly 150 years, and today our
medicines help more than 51 million people across the globe.
Harnessing the power of biotechnology, chemistry and genetic
medicine, our scientists are urgently advancing new discoveries to
solve some of the world's most significant health challenges:
redefining diabetes care; treating obesity and curtailing its most
devastating long-term effects; advancing the fight against
Alzheimer's disease; providing solutions to some of the most
debilitating immune system disorders; and transforming the most
difficult-to-treat cancers into manageable diseases. With each step
toward a healthier world, we're motivated by one thing: making life
better for millions more people. That includes delivering
innovative clinical trials that reflect the diversity of our world
and working to ensure our medicines are accessible and affordable.
To learn more, visit Lilly.com and Lilly.com/news, or follow us on
Facebook, Instagram and LinkedIn. P-LLY
i The efficacy estimand represents efficacy prior to
discontinuation of study drug.
ii The treatment-regimen estimand represents the
estimated average treatment effect regardless of treatment
discontinuation.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about tirzepatide as a potential option for adults with
moderate-to-severe obstructive sleep apnea and obesity and reflects
Lilly's current beliefs and expectations. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of drug research, development, and
commercialization. Among other things, there is no guarantee that
planned or ongoing studies will be completed as planned, that
future study results will be consistent with study results to date,
that tirzepatide will prove to be a safe and effective treatment
for moderate-to-severe sleep apnea, that tirzepatide
will receive additional regulatory approvals, or that Lilly will
execute its strategy as expected. For further discussion of these
and other risks and uncertainties that could cause actual results
to differ from Lilly's expectations, see Lilly's Form 10-K and Form
10-Q filings with the United States Securities and Exchange
Commission. Except as required by law, Lilly undertakes no duty to
update forward-looking statements to reflect events after the date
of this release.
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McEvoy RD, Antic NA,
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Peker Y, Glantz H,
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Positive Airway Pressure on Cardiovascular Outcomes in Coronary
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Sanchez-de-la-Torre M,
Sanchez-de-la-Torre A, Bertran S, et al. Effect of obstructive
sleep apnoea and its treatment with continuous positive airway
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Clarivate DRG. (2021).
(rep.). Obstructive Sleep Apnea Epidemiology- Diagnosed prevalent
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Refer to:
|
Brooke Frost;
brooke.frost@lilly.com; 317-432-9145 (Media)
|
|
Joe Fletcher;
jfletcher@lilly.com; 317-296-2884 (Investors)
|
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SOURCE Eli Lilly and Company