Participants using Zepbound lost 50.3 lbs
(22.8 kg) and participants on Wegovy lost 33.1 lbs (15.0
kg)
SURMOUNT-5 compared Zepbound, a dual GIP
and GLP-1 receptor agonist, to Wegovy, a mono GLP-1 receptor
agonist in adults living with obesity without
diabetes
INDIANAPOLIS, Dec. 4, 2024
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today
announced topline results from the SURMOUNT-5 phase 3b open-label randomized clinical trial.
Zepbound® (tirzepatide) provided a 47% greater relative
weight loss compared to Wegovy® (semaglutide). On
average, Zepbound led to a superior weight loss of 20.2%
compared to 13.7% with Wegovy.i At 72 weeks, Zepbound
beat Wegovy on both the primary endpoint and all five key secondary
endpoints in this trial of adults living with obesity or overweight
with at least one weight-related medical problem and without
diabetes.
"Given the increased interest around obesity medications, we
conducted this study to help health care providers and patients
make informed decisions about treatment choice," said Leonard C. Glass, MD, FACE, senior vice
president of global medical affairs at Lilly Cardiometabolic
Health. "We are thrilled that today's findings showed the superior
weight loss of Zepbound, which helped patients achieve 47% more
relative weight loss compared to Wegovy. Zepbound is in a class of
its own as the only FDA-approved dual GIP and GLP-1 receptor
agonist obesity medication, and it's changing how millions of
people manage this chronic disease."
In addition, in a key secondary endpoint, 31.6% of people taking
Zepbound achieved at least 25% body weight loss compared to 16.1%
of those taking Wegovy.
The overall safety profile of Zepbound in SURMOUNT-5 was similar
to previously reported SURMOUNT trials. The most commonly reported
adverse events in SURMOUNT-5 for both Zepbound and Wegovy were
gastrointestinal-related and were generally mild to moderate in
severity.
Lilly will continue to evaluate the SURMOUNT-5 results, which
will be published in a peer-reviewed journal and presented at a
medical meeting next year. Tirzepatide is
commercialized for adults with obesity or with overweight who
also have weight-related medical problems as Zepbound in the
U.S. and Mounjaro® in some global markets outside
the U.S. Tirzepatide is also commercialized as
Mounjaro for adults with type 2 diabetes in the U.S.
Semaglutide is commercialized as Wegovy for people living with
obesity or for adults with overweight who also have weight-related
medical problems and Ozempic for people with type 2
diabetes.
About SURMOUNT-5
SURMOUNT-5 (NCT05822830) was a multi-center, randomized,
open-label, phase 3b trial evaluating
the efficacy and safety of Zepbound® (tirzepatide)
compared with Wegovy® (semaglutide) in adults with
obesity, or overweight with at least one of the following
comorbidities: hypertension, dyslipidemia, obstructive sleep apnea
(OSA) or cardiovascular disease, who did not have diabetes. The
trial randomized 751 participants across the U.S. and Puerto Rico in a 1:1 ratio to receive maximum
tolerated dose of Zepbound (10 mg or 15 mg) or Wegovy (1.7 mg or
2.4 mg). The primary objective of the study was to demonstrate
Zepbound's superiority in percent change from baseline in body
weight at 72 weeks compared to Wegovy.
About tirzepatide
Tirzepatide is a once-weekly dual GIP (glucose-dependent
insulinotropic polypeptide) receptor and GLP-1 (glucagon-like
peptide-1) receptor agonist. Tirzepatide is a single molecule that
activates the body's receptors for GIP and GLP-1, which are natural
incretin hormones. Both GIP and GLP-1 receptors are found in areas
of the human brain important for appetite regulation. Tirzepatide
decreases calorie intake, and the effects are likely mediated by
affecting appetite. Studies of tirzepatide in chronic kidney
disease (CKD) and in morbidity/mortality in obesity (MMO) are
ongoing. Lilly submitted data for tirzepatide in moderate-to-severe
obstructive sleep apnea (OSA) and obesity and heart failure with
preserved ejection fraction (HFpEF) and obesity to the U.S. FDA and
other global regulatory agencies earlier this year.
Tirzepatide was approved by the U.S. FDA as
Mounjaro® for adults with type 2 diabetes to improve
glycemic control on May 13, 2022, and as Zepbound® for
adults with obesity or with excess weight and weight-related
medical problems on November 8, 2023. Tirzepatide is also
commercialized as Mounjaro in some global markets outside
the U.S. for adults with obesity or those who are overweight who
also have a weight-related comorbid condition.
Tirzepatide is the first and only approved dual GIP and GLP-1
receptor agonist treatment to reduce excess body weight and
maintain weight reduction long term. Both Mounjaro and Zepbound
should be used in combination with diet and exercise.
INDICATION AND SAFETY SUMMARY WITH WARNINGS
Zepbound® (ZEHP-bownd) is an injectable prescription
medicine that may help adults with obesity, or some adults with
overweight who also have weight-related medical problems to lose
excess body weight and keep the weight 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 for
use in children.
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.
Food or liquid getting into the lungs during surgery or other
procedures that use anesthesia or deep sleepiness (deep
sedation). Zepbound may increase the chance of food getting
into your lungs during surgery or other procedures. Tell all your
healthcare providers that you are taking Zepbound before you are
scheduled to have surgery or other procedures.
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 doctor 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 an insulin or sulfonylurea 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?
❑ Are you scheduled to have surgery or other procedures that use
anesthesia or deep sleepiness (deep sedation)?
❑ 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, or you may
contact Lilly at 1-800-LillyRx (1-800-545-5979).
How to take
- Read the Instructions for Use that come with Zepbound.
- Use Zepbound exactly as your healthcare provider says.
- Use Zepbound with a reduced-calorie diet and increased physical
activity.
- 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 1-800-222-1222.
Learn more
Zepbound is a prescription medicine. For more information, call
1-800-LillyRx (1-800-545-5979) or 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 18OCT2024
Zepbound® and its delivery device base are registered
trademarks owned or licensed by Eli Lilly and Company, its
subsidiaries, or affiliates.
MOUNJARO 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.
Food or liquid getting into the lungs during surgery or other
procedures that use anesthesia or deep sleepiness (deep
sedation). Mounjaro may increase the chance of food
getting into your lungs during surgery or other procedures. Tell
all your healthcare providers that you are taking Mounjaro before
you are scheduled to have surgery or other procedures.
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 scheduled to have surgery or other procedures
that use anesthesia or deep sleepiness (deep sedation)?
❑ 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 available as a pre-filled
single-dose pen in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg
per 0.5 mL injection. For more information, call 1-833-807-MJRO
(833-807-6576) or go to www.mounjaro.lilly.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 05NOV2024
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 tens of millions of 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 Data is based on the treatment-regimen estimand.
This estimand represents efficacy regardless of adherence to
randomized treatment and regardless of initiation of other
anti-obesity medication (except for switching to non-study
tirzepatide or semaglutide). This estimand assumes that
participants who had weight loss procedures during the study did
not get any benefit from their randomized study treatment.
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 Zepbound® (tirzepatide) as a treatment for adults with
obesity, or overweight with at least one comorbidity, who do not
have diabetes 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 future study results will be consistent
with study results to date, that Zepbound 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.
Refer to:
Rachel
Sorvig; sorvig_rachel@lilly.com; 317-607-7507
(Media)
Michael Czapar;
czapar_michael_c@lilly.com; 317-617-0983 (Investors)
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