Lilly's tirzepatide successful in phase 3 study showing benefit in adults with heart failure with preserved ejection fraction and obesity
Eli Lilly and Company (NYSE: LLY) announced positive topline results from the SUMMIT phase 3 clinical trial of tirzepatide in adults with heart failure with preserved ejection fraction (HFpEF) and obesity. The study met both primary endpoints:
1. 38% reduction in the risk of heart failure outcomes compared to placebo
2. Significant improvements in heart failure symptoms and physical limitations
Key secondary endpoints were also met, including improved exercise capacity, reduced inflammation, and 15.7% mean body weight reduction at 52 weeks. The safety profile was consistent with previous studies. Lilly plans to submit results to regulatory agencies later this year.
Eli Lilly and Company (NYSE: LLY) ha annunciato risultati promettenti dal trial clinico di fase 3 SUMMIT relativo a tirzepatide negli adulti con scompenso cardiaco con frazione d'eiezione preservata (HFpEF) e obesità. Lo studio ha raggiunto entrambi gli obiettivi principali:
1. Riduzione del 38% del rischio di esiti legati allo scompenso cardiaco rispetto al placebo
2. Miglioramenti significativi nei sintomi dello scompenso cardiaco e nelle limitazioni fisiche
Anche gli obiettivi secondari chiave sono stati raggiunti, inclusi il miglioramento della capacità di esercizio, la riduzione dell'infiammazione e una riduzione media del peso corporeo del 15,7% dopo 52 settimane. Il profilo di sicurezza è stato coerente con studi precedenti. Lilly prevede di presentare i risultati alle autorità di regolamentazione entro la fine di quest'anno.
Eli Lilly and Company (NYSE: LLY) anunció resultados positivos de primera línea del ensayo clínico de fase 3 SUMMIT de tirzepatida en adultos con insuficiencia cardíaca con fracción de eyección preservada (HFpEF) y obesidad. El estudio cumplió con ambos objetivos primarios:
1. Reducción del 38% en el riesgo de resultados de insuficiencia cardíaca en comparación con placebo
2. Mejoras significativas en los síntomas de insuficiencia cardíaca y limitaciones físicas
También se lograron los objetivos secundarios clave, que incluyen una mayor capacidad de ejercicio, reducción de la inflamación y una reducción media del peso corporal del 15.7% a las 52 semanas. El perfil de seguridad fue coherente con estudios anteriores. Lilly planea presentar los resultados a las agencias reguladoras más adelante este año.
엘리 릴리 앤 컴퍼니 (NYSE: LLY)는 트제파타이드의 3상 임상시험 SUMMIT에서 심부전(심박출량 보존형) 및 비만을 앓고 있는 성인에 대한 긍정적인 결과를 발표했습니다. 이 연구는 두 가지 주요 목표를 모두 달성했습니다:
1. 38%의 심부전 결과 위험 감소 (플라세보 대비)
2. 심부전 증상 및 신체적 제한의 상당한 개선
운동 능력 향상, 염증 감소 및 52주 후 평균 체중 15.7% 감소를 포함한 주요 보조 목표도 달성되었습니다. 안전성 프로필은 이전 연구와 일치했습니다. 릴리는 올해 말에 결과를 규제 기관에 제출할 계획입니다.
Eli Lilly and Company (NYSE: LLY) a annoncé des résultats prometteurs de la phase 3 de l'essai clinique SUMMIT sur tirzepatide chez des adultes souffrant de chroniques cardiaques avec fraction d'éjection préservée (HFpEF) et obésité. L'étude a atteint les deux objectifs principaux :
1. Réduction de 38% du risque d'événements liés à l'insuffisance cardiaque par rapport au placebo
2. Améliorations significatives des symptômes de l'insuffisance cardiaque et des limitations physiques
Les objectifs secondaires clés ont également été atteints, y compris une meilleure capacité d'exercice, une réduction de l'inflammation et une réduction moyenne du poids corporel de 15,7% après 52 semaines. Le profil de sécurité était conforme aux études précédentes. Lilly prévoit de soumettre les résultats aux agences réglementaires d'ici la fin de l'année.
Eli Lilly and Company (NYSE: LLY) hat positive Ergebnisse der SUMMIT-Phase-3-Studie zu tirzepatide bei Erwachsenen mit Herzinsuffizienz mit erhaltener Ejektionsfraktion (HFpEF) und Fettleibigkeit bekannt gegeben. Die Studie erreichte beide primären Endpunkte:
1. 38%ige Reduktion des Risikos für Herzinsuffizienzereignisse im Vergleich zur Placebo-Gruppe
2. Bedeutende Verbesserungen der Symptome der Herzinsuffizienz und der körperlichen Einschränkungen
Auch wichtige sekundäre Endpunkte wurden erreicht, darunter Verbesserung der körperlichen Leistungsfähigkeit, reduzierte Entzündung und eine mittelwertige Gewichtsreduktion von 15,7% nach 52 Wochen. Das Sicherheitsprofil war konsistent mit früheren Studien. Lilly plant, die Ergebnisse später in diesem Jahr den Zulassungsbehörden vorzulegen.
- Tirzepatide reduced the risk of heart failure outcomes by 38% compared to placebo
- Tirzepatide led to 15.7% weight loss in patients with and without type 2 diabetes
- All key secondary endpoints were met, including improved exercise capacity and reduced inflammation
- Tirzepatide significantly improved heart failure symptoms and physical limitations
- Results will be submitted to regulatory agencies, potentially expanding tirzepatide's indications
- Most common adverse events included gastrointestinal issues such as diarrhea, nausea, constipation, and vomiting
Insights
As a cardiology expert, I find the results of Eli Lilly's SUMMIT phase 3 trial for tirzepatide in heart failure with preserved ejection fraction (HFpEF) and obesity to be highly significant. The 38% reduction in heart failure outcomes is a substantial improvement over current treatment options. This is particularly noteworthy given that HFpEF has been a challenging condition to treat effectively.
The improvement in symptoms and physical limitations, as measured by the KCCQ-CSS, is clinically meaningful. A 24.8-point increase in the efficacy estimand group suggests a significant enhancement in patients' quality of life. Moreover, the improvement in exercise capacity, as measured by the 6-Minute Walk Test, further supports the drug's potential to improve functional outcomes in this patient population.
The 15.7% weight reduction observed in the trial is also remarkable, as obesity is a significant comorbidity in HFpEF patients. This weight loss could contribute to the overall improvement in heart failure outcomes by reducing the metabolic and hemodynamic burden on the heart.
However, it's important to note that while these results are promising, long-term safety and efficacy data will be crucial. The gastrointestinal side effects, while consistent with previous tirzepatide studies, may affect patient adherence in real-world settings. Overall, if approved, tirzepatide could represent a significant advancement in the management of HFpEF with obesity, addressing a critical unmet need in cardiovascular medicine.
From a pharmaceutical industry perspective, the positive results from the SUMMIT trial for tirzepatide in HFpEF and obesity patients represent a significant opportunity for Eli Lilly. This potential new indication could substantially expand the market for tirzepatide, which is already approved for type 2 diabetes and obesity under the brand names Mounjaro and Zepbound.
The 38% reduction in heart failure outcomes is a compelling efficacy profile that could position tirzepatide as a leading treatment option in this space. Given the large and growing population of patients with HFpEF and obesity, this could translate into substantial revenue potential for Lilly.
It's worth noting that tirzepatide's multi-modal effects - improving heart failure outcomes, reducing weight and potentially improving metabolic parameters - could give it a competitive edge in the market. This comprehensive approach aligns well with the evolving understanding of HFpEF as a multi-factorial syndrome.
Lilly's plan to submit these results to regulatory agencies later this year suggests a potential approval and launch timeline in the 2025-2026 range, assuming standard review times. This could provide a significant boost to Lilly's cardiovascular portfolio and further solidify its position in the incretin-based therapies market.
However, potential challenges include pricing and reimbursement considerations, given the drug's existing high cost for diabetes and obesity indications. Additionally, the market uptake will depend on how physicians and patients balance the significant efficacy with the gastrointestinal side effect profile. Overall, these results position Lilly for potential strong growth in the cardiovascular space, complementing its already robust diabetes and obesity franchise.
The SUMMIT trial results for tirzepatide in HFpEF and obesity patients are groundbreaking from a medical research perspective. This study addresses a critical gap in HFpEF treatment, a condition that has historically been challenging to manage effectively.
The trial design is noteworthy for several reasons:
- It's the first major trial to specifically target HFpEF patients with obesity, recognizing the frequent co-occurrence of these conditions.
- The inclusion of both symptom improvement (KCCQ-CSS) and hard clinical outcomes (heart failure events) as primary endpoints provides a comprehensive assessment of the drug's impact.
- The long median follow-up of 104 weeks allows for a robust evaluation of the drug's long-term efficacy and safety.
The 38% reduction in heart failure outcomes is particularly impressive, as it suggests tirzepatide could potentially modify the disease course in HFpEF, not just alleviate symptoms. The significant improvement in KCCQ-CSS scores (24.8 points in the efficacy estimand) indicates a substantial enhancement in patients' quality of life, which is a important consideration in chronic conditions like HFpEF.
The 15.7% weight loss observed in the trial is also significant, as it suggests tirzepatide could address multiple pathophysiological aspects of HFpEF simultaneously. This multi-modal effect (improving cardiac function, reducing weight and potentially improving metabolic parameters) aligns well with the complex nature of HFpEF and could represent a paradigm shift in its management.
However, it will be important to see the full data set, including subgroup analyses and detailed safety data, to fully understand the drug's potential impact and optimal patient population. The results of this trial could potentially influence future research directions in HFpEF, obesity and the intersection of metabolic and cardiovascular diseases.
Tirzepatide reduced the risk of heart failure outcomes – heart failure urgent visit or hospitalization, oral diuretic intensification or cardiovascular death – by
Tirzepatide significantly improved heart failure symptoms and physical limitations
Tirzepatide led to
All key secondary endpoints were also met, including improvement in exercise capacity as measured by the 6-Minute Walk-Test Distance (6MWD), reduction in the inflammation marker high-sensitivity C-reactive protein (hsCRP), and mean body weight reduction from baseline at 52 weeks. For the efficacy estimand,ii tirzepatide led to a
"HFpEF accounts for nearly half of all heart failure cases, and in the
Topline Primary Endpoint Results
Relative risk reduction of time-to-first (median follow up of 104 weeks) | - | ||
Efficacy Estimand | Treatment- | ||
Improvements in heart | Tirzepatide | 24.8 points
| 19.5 points
|
Placebo | 15.0 points | 12.7 points | |
HFpEF is a condition in which the heart's left pumping chamber becomes stiff and unable to fill properly. It is associated with a high burden of symptoms and physical limitations affecting daily life, including fatigue, shortness of breath, reduced ability to exercise and swelling of extremities.
The overall safety profile of tirzepatide in the SUMMIT trial was consistent with previously reported tirzepatide studies, including SURMOUNT and SURPASS. The most frequently reported adverse events in SUMMIT were primarily gastrointestinal in nature and generally mild to moderate in severity. The most common adverse events for patients treated with tirzepatide were diarrhea, nausea, constipation and vomiting.
Lilly will continue to evaluate the SUMMIT results, which will be presented at an upcoming medical meeting and submitted to a peer-reviewed journal. Lilly plans to submit the SUMMIT study results to the
About SUMMIT
SUMMIT (NCT04847557) was a multi-center, randomized, double-blind, parallel, placebo-controlled phase 3 study comparing the efficacy and safety of tirzepatide to placebo in adults living with heart failure with preserved ejection fraction (HFpEF) and obesity, with or without type 2 diabetes. The trial randomized 731 participants across the U.S., Argentina, Brazil,
SUMMIT utilized MTD of 5 mg, 10 mg or 15 mg once weekly. The starting dose of 2.5 mg tirzepatide was increased by 2.5 mg every four weeks until MTD was achieved. Participants who tolerated 15 mg continued on 15 mg as their MTD. Participants who tolerated 10 mg but did not tolerate 15 mg continued on 10 mg as their MTD, and participants who tolerated 5 mg but did not tolerate 10 mg continued on 5 mg as their MTD.
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 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. Both Mounjaro and Zepbound should be used as an adjunct to diet and exercise.
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.
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.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY
i The Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) is a patient-reported outcome instrument that uses a 1-100 point scale to assess heart failure symptoms and physical limitations. Higher KCCQ-CSS values indicate better symptom management and reduced physical limitations in people with heart failure.
ii The efficacy estimand represents efficacy prior to discontinuation of study drug.
iii The treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation.
References
- Borlaug BA, Jensen MD, Kitzman DW, Lam CSP, Obokata M, Rider OJ. Obesity and heart failure with preserved ejection fraction: new insights and pathophysiological targets. Cardiovasc Res. 2023;118(18):3434-3450. doi:10.1093/cvr/cvac120
Allen LA , Tang F, Jones P, Breeding T, Ponirakis A, Turner SJ. Signs, symptoms, and treatment patterns across serial ambulatory cardiology visits in patients with heart failure: insights from the NCDR PINNACLE® registry. BMC Cardiovasc Disord. 2018 May 3;18(1):80. doi: 10.1186/s12872-018-0808-2. PMID: 29724164; PMCID: PMC5934811.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about tirzepatide as a potential treatment for people with heart failure with preserved ejection fraction (HFpEF) and obesity 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 prove to be a safe and effective treatment for HFpEF and obesity, 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: | Kristiane Silva Bello: bello_kristiane@lilly.com, 317-315-9052 (Media) |
Joe Fletcher: jfletcher@lilly.com, 317-296-2884 (Investors) |
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