Treatment with tirzepatide in adults with pre-diabetes and obesity or overweight resulted in sustained weight loss and nearly 99% remained diabetes-free at 176 weeks
Eli Lilly's three-year Phase 3 SURMOUNT-1 study shows that tirzepatide significantly reduced type 2 diabetes risk in adults with pre-diabetes and obesity. The study demonstrated a 94% reduction in diabetes progression risk compared to placebo, with nearly 99% of treated participants remaining diabetes-free at 176 weeks. Participants achieved sustained weight loss averaging 22.9% with the 15 mg dose. The results suggest that one new case of diabetes could be prevented for every nine patients treated. The treatment also showed improvements in glycemic control, cardiometabolic risk factors, and health-related quality of life. Common side effects were primarily gastrointestinal and mild to moderate.
Lo studio di fase 3 SURMOUNT-1 di Eli Lilly, della durata di tre anni, mostra che tirzepatide ha ridotto significativamente il rischio di diabete di tipo 2 negli adulti con pre-diabete e obesità. Lo studio ha dimostrato una riduzione del 94% del rischio di progressione del diabete rispetto al placebo, con quasi 99% dei partecipanti trattati che sono rimasti liberi da diabete a 176 settimane. I partecipanti hanno raggiunto una perdita di peso sostenuta media del 22,9% con la dose di 15 mg. I risultati suggeriscono che un nuovo caso di diabete potrebbe essere prevenuto per ogni nove pazienti trattati. Il trattamento ha mostrato anche miglioramenti nel controllo glicemico, nei fattori di rischio cardiometabolico e nella qualità della vita legata alla salute. Gli effetti collaterali comuni erano principalmente gastrointestinali e da lievi a moderati.
El estudio de fase 3 SURMOUNT-1 de Eli Lilly durante tres años muestra que tirzepatida redujo significativamente el riesgo de diabetes tipo 2 en adultos con prediabetes y obesidad. El estudio demostró una reducción del 94% en el riesgo de progresión de la diabetes en comparación con el placebo, con casi 99% de los participantes tratados permaneciendo libres de diabetes a las 176 semanas. Los participantes lograron una pérdida de peso sostenida promedio del 22,9% con la dosis de 15 mg. Los resultados sugieren que se podría prevenir un nuevo caso de diabetes por cada nueve pacientes tratados. El tratamiento también mostró mejoras en el control glucémico, los factores de riesgo cardiometabólico y la calidad de vida relacionada con la salud. Los efectos secundarios comunes eran principalmente gastrointestinales y de leves a moderados.
엘리 릴리의 3년간 진행된 3상 SURMOUNT-1 연구는 티르제파타이드가 전당뇨 및 비만이 있는 성인의 2형 당뇨병 위험을 상당히 감소시켰음을 보여줍니다. 연구 결과, 플라시보와 비교했을 때 당뇨병 진행 위험이 94% 줄어들었으며, 치료를 받은 참가자의 거의 99%가 176주 동안 당뇨병이 없는 상태를 유지했습니다. 참가자들은 15mg 용량으로 평균 22.9%의 지속적인 체중 감량을 달성했습니다. 결과는 치료받은 아홉 명의 환자마다 새로운 당뇨병 사례 하나를 예방할 수 있다는 것을 시사합니다. 치료는 또한 혈당 조절, 심대사 위험 요소 및 건강 관련 삶의 질에서 개선을 보여주었습니다. 일반적인 부작용은 주로 위장 관련이며 경미하거나 중등도였습니다.
Une étude de phase 3 de Eli Lilly, intitulée SURMOUNT-1 et réalisée sur trois ans, montre que tirzepatide a réduit significativement le risque de diabète de type 2 chez les adultes présentant une prédiabète et une obésité. L'étude a démontré une réduction de 94% du risque de progression vers le diabète par rapport au placebo, avec près de 99% des participants traités restant sans diabète après 176 semaines. Les participants ont atteint une perte de poids durable moyenne de 22,9% avec la dose de 15 mg. Les résultats suggèrent qu'un nouvel épisode de diabète pourrait être prévenu pour chaque neuf patients traités. Le traitement a également montré des améliorations dans le contrôle glycémique, les facteurs de risque cardiométaboliques et la qualité de vie liée à la santé. Les effets secondaires courants étaient principalement gastro-intestinaux et légers à modérés.
Die dreijährige Phase-3-Studie SURMOUNT-1 von Eli Lilly zeigt, dass Tirzepatid das Risiko für Typ-2-Diabetes bei Erwachsenen mit Prädiabetes und Fettleibigkeit erheblich senkt. Die Studie ergab eine 94%ige Reduktion des Risikos für die Diabetesprogression im Vergleich zur Placebogruppe, wobei fast 99% der behandelten Teilnehmer nach 176 Wochen diabetesfrei blieben. Die Teilnehmer erreichten einen durchschnittlichen nachhaltigen Gewichtsverlust von 22,9% mit der Dosis von 15 mg. Die Ergebnisse deuten darauf hin, dass für jeden neun behandelten Patienten ein neuer Diabetesfall verhindert werden könnte. Die Behandlung zeigte auch Verbesserungen bei der glykämischen Kontrolle, den kardiometabolischen Risikofaktoren und der gesundheitsbezogenen Lebensqualität. Häufige Nebenwirkungen waren hauptsächlich gastrointestinal und mild bis moderat.
- 94% reduction in risk of progression to type 2 diabetes compared to placebo
- Sustained weight loss of 22.9% with 15 mg dose over three years
- 99% of treated participants remained diabetes-free at 176 weeks
- Favorable number needed to treat (NNT) of 9 patients to prevent one diabetes case
- Improvements in multiple cardiometabolic risk factors
- Presence of gastrointestinal side effects (nausea, diarrhea, constipation)
Insights
The three-year SURMOUNT-1 trial results represent a landmark achievement in obesity and diabetes prevention. The
The dual GIP/GLP-1 mechanism shows superior efficacy compared to single-target therapies. The sustained benefits over 176 weeks, including improvements in cardiometabolic markers, suggest tirzepatide could revolutionize obesity treatment paradigms. The safety profile remains consistent with previous data, with manageable gastrointestinal side effects.
These results significantly strengthen Lilly's position in the rapidly growing obesity market. Tirzepatide's superior efficacy data could drive substantial market share gains from competitors like Novo Nordisk's Wegovy. The diabetes prevention aspect opens additional market opportunities and potential reimbursement pathways.
The durability of weight loss and high diabetes prevention rate could support premium pricing and broader insurance coverage. With obesity affecting over 40% of U.S. adults, tirzepatide's strong efficacy profile positions Lilly to capture a significant share of this multi-billion dollar market, potentially becoming one of the highest-grossing drugs in history.
SURMOUNT-1 results show a
Results suggest one new case of diabetes could be prevented for every nine patients treated with tirzepatide
Participants treated with tirzepatide had an average weight reduction of
"Individuals treated with tirzepatide lost on average up to
Tirzepatide is the first and only approved dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist medicine. Both GIP and GLP-1 are gut hormones secreted in response to nutrient load and are responsible for the incretin effect.
"In the SURMOUNT-1 three-year study of tirzepatide, an average weight reduction of up to
In additional endpoints, the study showed an association of tirzepatide treatment with improvements in glycemic control, cardiometabolic risk factors (including fasting insulin, blood pressure and lipids) and health-related quality of life, which were sustained through 176 weeksii. A post hoc mediation analysis suggested that approximately half of the observed effect in delay to onset of type 2 diabetes with tirzepatide was associated with medication-induced weight reduction, with the remaining benefit potentially attributed to other effects of tirzepatide.
The overall safety and tolerability profile of tirzepatide at 193 weeks (176 weeks followed by 17 weeks off-treatment) was consistent with the previously published results at 72 weeks for SURMOUNT-1 and other tirzepatide clinical studies conducted for weight reduction and long-term maintenance. Other than COVID-19, the most frequently reported adverse events were gastrointestinal-related and generally mild to moderate in severity. The most common gastrointestinal-related adverse events in patients treated with tirzepatide were nausea, diarrhea and constipation.
Full Results
SURMOUNT-1 Three-Year Study: Key Secondary Endpoints (p<0.0001, controlled for type 1 error) | ||||||
Key Secondary Endpoints at Week 176 (end of treatment period) | ||||||
Efficacy Estimandi | Treatment-Regimen Estimandiii | |||||
Percentage of Participants Diagnosed with Type 2 Diabetes | ||||||
Tirzepatide (5 mg, 10 mg and (n=762) | 1.2 % | 1.3 % | ||||
Placebo (n=270) | 12.6 % | 13.3 % | ||||
Reduction in Risk of Progression to Type 2 Diabetes | ||||||
Tirzepatide (5 mg, 10 mg and | Hazard Ratio=0.06 | Hazard Ratio=0.07 | ||||
Tirzepatide (5 mg, 10 mg and | Number Needed to Treat to | Number Needed to Treat to Prevent One Case of Diabetes=9ii | ||||
Average Percent Body Weight Reduction from Baseline | ||||||
Tirzepatide | 5 mgiv | 10 mg (n=260) | 15 mg (n=249) | 5 mgiv (n=247) | 10 mg (n=262) | 15 mg (n=253) |
15.4 % | 19.9 % | 22.9 % | 12.3 % | 18.7 % | 19.7 % | |
Placebo | 2.1 % (n=264) | 1.3 % (n=270) | ||||
Key Secondary Endpointv at Week 193 (end of 17-week off-treatment follow-up period) | ||||||
Percentage of Participants Diagnosed with Type 2 Diabetes | ||||||
Tirzepatide 15 mg pooled doses) | 2.4 % | |||||
Placebo (n=270) | 13.7 % | |||||
Reduction in Risk of Progression to Type 2 Diabetes | ||||||
Tirzepatide 15 mg pooled doses) | Hazard Ratio=0.12 | |||||
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 had 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 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 to the U.S. Food and Drug Administration (FDA) and other global regulatory agencies earlier this year. Lilly plans to submit data for tirzepatide in heart failure with preserved ejection fraction (HFpEF) and obesity to the U.S. FDA and other global regulatory agencies later 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 those who are overweight who also have at least one weight-related medical problem 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 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.
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. 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.If you take too much Mounjaro, call your healthcare provider or seek medical advice promptly.
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
References
i The efficacy estimand represents efficacy had all patients remained on randomized treatment for the entire planned treatment duration (up to 176 weeks).
ii Not controlled for type 1 error.
iii The treatment-regimen estimand represents efficacy regardless of adherence to randomized treatment.
iv 5 mg weekly tirzepatide injections evaluating change in body weight not controlled for type 1 error.
v The analysis was conducted regardless of adherence to randomized treatment from randomization to the end of safety follow-up at 193 weeks.
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 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 readouts, presentations, and other milestones relating to tirzepatide and its clinical trials, 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 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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FAQ
What was the weight loss percentage achieved with tirzepatide (LLY) in the SURMOUNT-1 trial?
How effective was tirzepatide (LLY) in preventing type 2 diabetes in the SURMOUNT-1 study?
What were the main side effects of tirzepatide (LLY) in the SURMOUNT-1 trial?
How many patients need to be treated with tirzepatide (LLY) to prevent one case of diabetes?
