Tirzepatide reduced the risk of developing type 2 diabetes by 94% in adults with pre-diabetes and obesity or overweight
Eli Lilly's tirzepatide showed remarkable results in a 176-week SURMOUNT-1 Phase 3 study for long-term weight management and diabetes prevention. The drug reduced the risk of developing type 2 diabetes by 94% in adults with pre-diabetes and obesity or overweight. Participants on the 15 mg dose experienced an average 22.9% decrease in body weight compared to 2.1% for placebo.
The study involved 1,032 adults with pre-diabetes and obesity or overweight. Tirzepatide, a GIP and GLP-1 receptor agonist, demonstrated sustained weight loss and significant reduction in diabetes risk throughout the treatment period. The safety profile was consistent with previous studies, with gastrointestinal-related adverse events being most common.
Il tirzepatide di Eli Lilly ha mostrato risultati notevoli in uno studio di fase 3 SURMOUNT-1 della durata di 176 settimane per la gestione del peso a lungo termine e la prevenzione del diabete. Il farmaco ha ridotto il rischio di sviluppare diabete di tipo 2 del 94% negli adulti con pre-diabete e obesità o sovrappeso. I partecipanti che assumevano la dose da 15 mg hanno registrato una media di 22,9% di riduzione del peso corporeo rispetto al 2,1% del gruppo di controllo.
Lo studio ha coinvolto 1.032 adulti con pre-diabete e obesità o sovrappeso. Il tirzepatide, un agonista dei recettori GIP e GLP-1, ha dimostrato una perdita di peso sostenuta e una significativa riduzione del rischio di diabete durante tutto il periodo di trattamento. Il profilo di sicurezza era coerente con studi precedenti, con eventi avversi gastrointestinali che risultavano essere i più comuni.
El tirzepatide de Eli Lilly mostró resultados notables en un estudio de fase 3 SURMOUNT-1 de 176 semanas para la gestión del peso a largo plazo y la prevención de la diabetes. El fármaco redujo el riesgo de desarrollar diabetes tipo 2 en un 94% en adultos con prediabetes y obesidad o sobrepeso. Los participantes con la dosis de 15 mg experimentaron una disminución promedio del 22,9% en el peso corporal en comparación con el 2,1% del grupo placebo.
El estudio involucró a 1,032 adultos con prediabetes y obesidad o sobrepeso. El tirzepatide, un agonista de los receptores GIP y GLP-1, demostró una pérdida de peso sostenida y una reducción significativa del riesgo de diabetes durante todo el período de tratamiento. El perfil de seguridad fue consistente con estudios anteriores, siendo los eventos adversos relacionados con el tracto gastrointestinal los más comunes.
엘리 릴리의 틀제파타이드가 176주간의 SURMOUNT-1 3상 연구에서 장기 체중 관리와 당뇨병 예방에 놀라운 결과를 보였습니다. 이 약물은 비만 또는 과체중인 전당뇨 성인에서 2형 당뇨병 발생 위험을 94% 감소시켰습니다. 15mg 용량을 복용한 참가자는 위약군의 2.1%에 비해 평균 체중의 22.9% 감소를 경험했습니다.
이 연구는 전당뇨 및 비만 또는 과체중인 1,032명의 성인이 참여했습니다. 틀제파타이드는 GIP 및 GLP-1 수용체 작용제로, 치료 기간 동안 지속적인 체중 감소와 당뇨병 위험의 유의미한 감소를 나타냈습니다. 안전성 프로필은 이전 연구와 일치하며, 위장 관련 부작용이 가장 흔했습니다.
Le tirzepatide d'Eli Lilly a montré des résultats remarquables lors d'une étude de phase 3 SURMOUNT-1 de 176 semaines pour la gestion à long terme du poids et la prévention du diabète. Le médicament a réduit le risque de développer un diabète de type 2 de 94% chez les adultes avec prédiabète et obésité ou surpoids. Les participants prenant la dose de 15 mg ont montré une réduction moyenne de 22,9% du poids corporel contre 2,1% pour le placebo.
L'étude a impliqué 1 032 adultes avec prédiabète et obésité ou surpoids. Le tirzepatide, un agoniste des récepteurs GIP et GLP-1, a démontré une perte de poids soutenue et une réduction significative du risque de diabète tout au long de la période de traitement. Le profil de sécurité était cohérent avec les études précédentes, les événements indésirables liés au système gastro-intestinal étant les plus fréquents.
Tirzepatid von Eli Lilly zeigte bemerkenswerte Ergebnisse in einer 176-wöchigen SURMOUNT-1 Phase 3-Studie zur langfristigen Gewichtsmanagement und Prävention von Diabetes. Das Medikament reduzierte das Risiko, Typ-2-Diabetes um 94% bei Erwachsenen mit Vorstufe von Diabetes und Adipositas oder Übergewicht zu entwickeln. Die Teilnehmer, die eine Dosis von 15 mg erhielten, erlebten einen durchschnittlichen Gewichtsverlust von 22,9% im Vergleich zu 2,1% in der Placebo-Gruppe.
Die Studie umfasste 1.032 Erwachsene mit Vorstufe von Diabetes und Adipositas oder Übergewicht. Tirzepatid, ein GIP- und GLP-1-Rezeptor-Agonist, zeigte während der Behandlungsdauer einen nachhaltigen Gewichtsverlust und eine signifikante Reduzierung des Diabetesrisikos. Das Sicherheitsprofil war mit früheren Studien konsistent, wobei gastrointestinal bedingte Nebenwirkungen am häufigsten waren.
- Tirzepatide reduced the risk of developing type 2 diabetes by 94% compared to placebo
- 15 mg dose of tirzepatide resulted in 22.9% average decrease in body weight compared to 2.1% for placebo
- Sustained weight loss was observed throughout the 176-week treatment period
- Tirzepatide (10 mg and 15 mg) led to statistically significant weight reduction compared to placebo
- The safety profile was consistent with previous studies, indicating no new safety concerns
- During the 17-week off-treatment follow-up period, participants who discontinued tirzepatide began to regain weight
- Some increase in the progression to type 2 diabetes was observed after discontinuation of tirzepatide
- The most common adverse events were gastrointestinal-related, including diarrhea, nausea, constipation, and vomiting
Insights
The 94% reduction in risk of progression to type 2 diabetes with tirzepatide is a groundbreaking result. This level of efficacy surpasses previous interventions for pre-diabetes, potentially revolutionizing preventive care. The sustained weight loss of 22.9% over 176 weeks with the 15 mg dose is equally impressive, addressing a key challenge in obesity treatment - long-term maintenance. These results suggest tirzepatide could be a game-changer in managing the obesity-diabetes continuum.
The dual action on GIP and GLP-1 receptors likely contributes to tirzepatide's superior efficacy. This mechanism not only regulates appetite and caloric intake but also enhances insulin sensitivity and secretion, providing a multi-faceted approach to metabolic health. The safety profile, consistent with previous studies, is reassuring for long-term use.
Eli Lilly's tirzepatide results are highly positive for the company's financial outlook. The drug's exceptional efficacy in preventing diabetes and sustaining weight loss positions it as a potential blockbuster in the lucrative obesity and diabetes markets. With nearly 900 million adults worldwide at risk, the market potential is enormous.
The long-term efficacy data strengthens tirzepatide's competitive advantage over existing treatments, potentially leading to increased market share and premium pricing. This could significantly boost Lilly's revenue and profit margins in the coming years. However, investors should consider potential challenges such as insurance coverage and competition from emerging obesity treatments. Overall, these results are likely to positively impact Lilly's stock performance and long-term growth prospects.
The SURMOUNT-1 study results have significant public health implications. A 94% reduction in type 2 diabetes risk could dramatically reduce the global diabetes burden, potentially saving healthcare systems billions in long-term costs. The sustained weight loss of
However, accessibility and affordability of tirzepatide will be important for realizing its public health potential. Policymakers and healthcare systems must consider how to implement this treatment effectively, balancing cost with potential long-term savings from prevented diabetes cases and obesity-related complications. Education on lifestyle modifications should still be emphasized alongside pharmacological interventions to ensure comprehensive obesity management.
176-week SURMOUNT-1 Phase 3 study in adults with pre-diabetes is the longest completed trial of tirzepatide to date
Tirzepatide resulted in sustained weight loss through the treatment period, averaging a
Results are consistent with the combined pharmacology of GIP and GLP-1 receptor agonism
"Obesity is a chronic disease that puts nearly 900 million adults worldwide at an increased risk of other complications such as type 2 diabetes," said Jeff Emmick, M.D., Ph.D., senior vice president, product development, Lilly. "Tirzepatide reduced the risk of developing type 2 diabetes by
Tirzepatide was evaluated in 1,032 adults who had pre-diabetes at randomization and obesity or overweight for a treatment period of 176 weeks, followed by a 17-week off-treatment period (193 weeks in total). Results from the SURMOUNT-1 phase 3 study's primary analysis at 72 weeks in all participants were published in the New England Journal of Medicine in 2022.
In a key secondary endpoint, tirzepatide led to a significant reduction in the risk of progression to type 2 diabetes in adults with pre-diabetes and obesity or overweight from baseline to week 176 (p<0.0001, controlled for type 1 error). For the efficacy estimandii, pooled doses of tirzepatide achieved significant results, demonstrating a
In an additional key secondary endpoint, tirzepatide (10 mg and 15 mg) led to statistically significant weight reduction compared to placebo in adults with pre-diabetes and obesity or overweight from baseline to week 176 (p<0.001, controlled for type 1 error). For the efficacy estimandii, adults taking tirzepatide achieved average weight reductions of
During the 17-week off-treatment follow-up period, those who had discontinued from tirzepatide began to regain weight and had some increase in the progression to type 2 diabetes, resulting in an
The overall safety and tolerability profile of tirzepatide over the 193-week study was consistent with the previously published primary results at 72 weeks in SURMOUNT-1 and other tirzepatide clinical studies conducted for chronic weight management. The most frequently reported adverse events were typically gastrointestinal-related and generally mild to moderate in severity. The most common gastrointestinal-related adverse events for patients treated with tirzepatide were diarrhea, nausea, constipation and vomiting.
Tirzepatide, a GIP and GLP-1 receptor agonist, works by activating the two hormone receptors. GLP-1 is a regulator of appetite and caloric intake. Nonclinical studies suggest the addition of GIP may further contribute to the regulation of food intake. Tirzepatide decreases calorie intake, and the effects are likely mediated by affecting appetite. In addition, tirzepatide stimulates insulin secretion in a glucose-dependent manner. Tirzepatide increases insulin sensitivity in patients with type 2 diabetes mellitus and these effects can lead to a reduction of blood glucose.
These topline results provide evidence for reduced risk of progression to type 2 diabetes and long-term maintenance of weight loss with tirzepatide in adults with pre-diabetes and obesity or overweight. Detailed results will be submitted to a peer-reviewed journal and presented at ObesityWeek 2024, which will take place November 3-6.
About SURMOUNT-1
SURMOUNT-1 (NCT04184622) was a multi-center, randomized, double-blind, parallel, placebo-controlled trial comparing the efficacy and safety of tirzepatide 5 mg, 10 mg and 15 mg to placebo as an adjunct to a reduced-calorie diet and increased physical activity in adults without type 2 diabetes who have obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea (OSA) or cardiovascular disease. The 1,032 participants who had pre-diabetes at study commencement remained enrolled in SURMOUNT-1 for an additional 104 weeks of treatment following the initial 72-week completion date to evaluate the impact on body weight and potential differences in progression to type 2 diabetes at three years of treatment with tirzepatide compared to placebo.
About tirzepatide
Tirzepatide is a once-weekly 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 has been shown to decrease food intake and modulate fat utilization. Studies of tirzepatide in chronic kidney disease (CKD) and in morbidity/mortality in obesity (MMO) are also ongoing. Lilly submitted data for tirzepatide in moderate-to-severe obstructive sleep apnea (OSA) 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 (a BMI of 30 kg/m2 or greater) or those who are overweight (a BMI of 27 kg/m2 or greater) who also have a weight-related comorbid condition on November 8, 2023. Tirzepatide is also commercialized as Mounjaro® in some global markets outside the
Tirzepatide is the only approved GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) treatment for chronic weight management. Both Mounjaro® and Zepbound® should be used as an adjunct to diet and exercise.
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, 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.
- 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 08NOV2023
Zepbound® and its delivery device base are registered 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 Not controlled for type 1 error.
ii The efficacy estimand represents efficacy had all patients remained on randomized treatment for the entire planned treatment duration (up to 176 weeks).
iii The treatment-regimen estimand represents efficacy regardless of adherence to randomized 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), including statements about tirzepatide injection for the treatment of adults with type 2 diabetes, tirzepatide as a potential long-term therapy for adults with pre-diabetes and obesity or overweight and the timeline for future presentations and other milestones relating to tirzepatide and its clinical trials, and reflects Lilly's current belief and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of research development and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, that tirzepatide will receive additional regulatory approvals, or that tirzepatide will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent 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: | Courtney C Kasinger: ckasinger@lilly.com, 317-501-7056 (Media) |
Joe Fletcher: jfletcher@lilly.com, 317-296-2884 (Investors) |
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FAQ
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