Lilly's Zepbound® (tirzepatide) superior to Wegovy® (semaglutide) in head-to-head trial showing an average weight loss of 20.2% vs. 13.7%
Eli Lilly's Zepbound demonstrated superior weight loss results compared to Wegovy in the SURMOUNT-5 phase 3b clinical trial. Participants using Zepbound achieved an average weight loss of 20.2% (50.3 lbs) compared to 13.7% (33.1 lbs) with Wegovy, representing a 47% greater relative weight loss.
The trial met both its primary endpoint and all five key secondary endpoints. Notably, 31.6% of Zepbound users achieved at least 25% body weight loss versus 16.1% for Wegovy users. The safety profile was consistent with previous SURMOUNT trials, with mainly mild to moderate gastrointestinal-related adverse events reported for both medications.
Zepbound di Eli Lilly ha mostrato risultati superiori nella perdita di peso rispetto a Wegovy nel trial clinico di fase 3b SURMOUNT-5. I partecipanti che usavano Zepbound hanno ottenuto una perdita di peso media del 20,2% (50,3 lbs) rispetto al 13,7% (33,1 lbs) di Wegovy, rappresentando una perdita di peso relativa superiore del 47%.
Lo studio ha raggiunto sia l'obiettivo primario che tutti e cinque gli obiettivi secondari chiave. È importante notare che il 31,6% degli utenti di Zepbound ha raggiunto almeno il 25% di perdita di peso corporeo contro il 16,1% degli utenti di Wegovy. Il profilo di sicurezza è stato coerente con i precedenti trial SURMOUNT, con principalmente eventi avversi gastrointestinali da lievi a moderati segnalati per entrambi i farmaci.
Zepbound de Eli Lilly demostró resultados superiores en la pérdida de peso en comparación con Wegovy en el ensayo clínico de fase 3b SURMOUNT-5. Los participantes que usaron Zepbound lograron una pérdida de peso promedio del 20,2% (50,3 lbs) en comparación con el 13,7% (33,1 lbs) de Wegovy, lo que representa una pérdida de peso relativa superior del 47%.
El ensayo cumplió con su objetivo principal y con los cinco objetivos secundarios clave. Notablemente, el 31,6% de los usuarios de Zepbound alcanzó al menos el 25% de pérdida de peso corporal frente al 16,1% de los usuarios de Wegovy. El perfil de seguridad fue consistente con los ensayos SURMOUNT anteriores, con principalmente eventos adversos gastrointestinales leves a moderados reportados para ambos medicamentos.
엘리 릴리의 Zepbound는 SURMOUNT-5 3b 임상 시험에서 Wegovy에 비해 우수한 체중 감소 결과를 보여주었습니다. Zepbound를 사용한 참가자는 평균 20.2% (50.3 lbs)의 체중 감소를 달성했으며, Wegovy는 13.7% (33.1 lbs)로 47% 더 큰 상대적 체중 감소를 나타냈습니다.
이 시험은 주요 목표와 다섯 가지 주요 이차 목표를 모두 달성했습니다. 특히, 31.6%의 Zepbound 사용자들이 최소 25%의 체중 감소를 달성한 반면, Wegovy 사용자들은 16.1%를 기록했습니다. 안전성 프로필은 이전 SURMOUNT 시험과 일치하며, 두 약물 모두에서 주로 경증에서 중등도의 위장 관련 부작용이 보고되었습니다.
Zepbound d'Eli Lilly a montré des résultats de perte de poids supérieurs à ceux de Wegovy lors de l'essai clinique de phase 3b SURMOUNT-5. Les participants ayant utilisé Zepbound ont réalisé une perte de poids moyenne de 20,2% (50,3 lbs) contre 13,7% (33,1 lbs) avec Wegovy, représentant une perte de poids relative supérieure de 47%.
L'essai a atteint son objectif principal ainsi que les cinq objectifs secondaires clés. Il est à noter que 31,6% des utilisateurs de Zepbound ont atteint au moins 25% de perte de poids corporel contre 16,1% pour les utilisateurs de Wegovy. Le profil de sécurité était cohérent avec les essais SURMOUNT précédents, avec principalement des événements indésirables gastro-intestinaux légers à modérés signalés pour les deux médicaments.
Zepbound von Eli Lilly zeigte im klinischen Test der Phase 3b SURMOUNT-5 überlegene Ergebnisse beim Gewichtsverlust im Vergleich zu Wegovy. Die Teilnehmer, die Zepbound verwendeten, erzielten einen durchschnittlichen Gewichtsverlust von 20,2% (50,3 lbs) im Vergleich zu 13,7% (33,1 lbs) mit Wegovy, was einen relativen Gewichtsverlust von 47% darstellt.
Die Studie erfüllte sowohl das primäre Ziel als auch alle fünf wesentlichen sekundären Ziele. Bemerkenswerterweise erreichten 31,6% der Zepbound-Nutzer mindestens 25% Gewichtsverlust, während es bei Wegovy-Nutzern 16,1% waren. Das Sicherheitsprofil war mit früheren SURMOUNT-Studien konsistent, wobei hauptsächlich leichte bis moderate gastrointestinal bedingte Nebenwirkungen für beide Medikamente berichtet wurden.
- Superior efficacy with 47% greater relative weight loss compared to competitor Wegovy
- Achieved significant 20.2% average weight loss (50.3 lbs)
- Met all primary and secondary endpoints in phase 3b trial
- 31.6% of patients achieved ≥25% body weight loss, nearly double Wegovy's rate
- Reported gastrointestinal-related adverse events in trial participants
Insights
The SURMOUNT-5 trial results represent a significant competitive advantage for Lilly's Zepbound in the rapidly growing obesity treatment market. The 47% greater relative weight loss compared to Wegovy is a remarkable achievement, with participants losing an average of
The superior efficacy is particularly noteworthy in the
The comparable safety profile with primarily mild to moderate gastrointestinal side effects suggests no significant trade-off between enhanced efficacy and safety concerns, strengthening Zepbound's market position.
These results could significantly impact Lilly's market dominance in the obesity treatment sector, which is projected to reach
The timing is particularly strategic as demand for weight loss medications continues to surge. With both efficacy and safety advantages, Zepbound could capture a larger portion of this expanding market. The results may also influence insurance coverage decisions and formulary placements, potentially accelerating adoption rates.
This data strengthens Lilly's position in negotiations with payers and could lead to increased market penetration, supporting continued revenue growth in their obesity franchise.
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
"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
In addition, in a key secondary endpoint,
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
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
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
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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SOURCE Eli Lilly and Company
FAQ
What was the average weight loss difference between Zepbound and Wegovy in the SURMOUNT-5 trial (LLY)?
What percentage of patients achieved 25% or more weight loss with Zepbound vs Wegovy in the LLY trial?
What were the main side effects reported in the SURMOUNT-5 trial for Zepbound (LLY)?
