Insulin lispro

固定剂量QWINT-1研究 ，以及QWINT-3和QWINT-4研究结果，均表明efsitora可通过周制剂简化胰岛素治疗礼来计划于今年年底前向全球监管机构递交efsitora用于治疗2型糖尿病成人患者的上市申请2025年6月22日，礼来宣布了QWINT-1、QWINT-3和QWINT-4三项3期临床研究的详细结果。这些研究分别评估了每周一次胰岛素efsitora alfa（efsitora）在首次使用胰岛素治疗、既往已使用每日基础胰岛素治疗，以及既往基础胰岛素与餐时胰岛素联用的2型糖尿病（T2DM）成人患者中的有效性和安全性。所有研究中均达到了主要终点，即每周一次的efsitora在降低糖化血红蛋白（A1C）水平方面非劣效于每日一次基础胰岛素。这些研究的完整结果已在美国糖尿病协会（ADA）第85届科学会议上公布。其中，首创的固定剂量研究QWINT-1结果同步发表于《新英格兰医学杂志》（The New England Journal of Medicine），QWINT-3和QWINT-4研究结果同步发表于《柳叶刀》（The Lancet）。声明：1. Insulin efsitora alfa (efsitora)为研究中的药品，尚未在中国获批2. 礼来不推荐任何未获批的药品/适应症使用QWINT-1研究中，有效性估计目标显示，在第52周时efsitora组A1C降低1.31%，甘精胰岛素组降低1.27%。1,2在该研究中，efsitora每4周根据血糖控制情况采用四个固定剂量进行滴定。3在QWINT-3研究中，有效性估计目标显示，在第26周时efsitora组A1C降低0.86%，德谷胰岛素组降低0.75%。4在QWINT-4研究中，有效性估计目标显示，在第26周时，efsitora组和甘精胰岛素组A1C均降低1.07%。5在QWINT-3和QWINT-4研究中，efsitora均采用灵活的胰岛素剂量调整方法根据血糖控制情况进行给药。QWINT-1主要研究者、达拉斯城市医学Velocity临床研究中心科学顾问、德克萨斯大学西南医学中心临床医学教授Julio Rosenstock博士表示：QWINT-1中采用创新的每周一次固定剂量efsitora治疗方案，由四个固定剂量组成，这将有望简化胰岛素治疗流程，消除2型糖尿病患者对起始胰岛素治疗的顾虑。这种简便的周制剂方案或能帮助患者更顺利地开启和管理胰岛素治疗，从而实现血糖改善的目标。所有QWINT研究均表明，efsitora的血糖控制效果与目前最常用的每日基础胰岛素相当。QWINT-1主要终点QWINT-3主要终点和关键次要终点QWINT-4主要终点和关键次要终点礼来产品研发高级副总裁Jeff Emmick博士表示：长期以来，礼来深耕胰岛素治疗领域并持续引领创新。每周一次的efsitora有望为亟待胰岛素治疗的2型糖尿病患者带来重大突破——每年可减少300多次注射。本次研究结果表明，通过efsitora这种周制剂简化治疗流程，将帮助减轻胰岛素治疗带来的整体负担。我们将与全球监管机构合作，让这一创新疗法得以惠及全球患者。在上述三项临床研究中，efsitora的安全性与目前T2DM治疗中最常用的两种每日基础胰岛素相似。在QWINT-1研究中，efsitora组较甘精胰岛素组低血糖事件比例低40%；在第52周时，efsitora组与甘精胰岛素组的严重或具有临床意义的低血糖事件估计综合发生率分别为0.50（患者/年）和0.88（患者/年）。在QWINT-3研究中，第78周时上述事件发生率在efsitora组为0.84（患者/年），德谷胰岛素组为0.74（患者/年）。在QWINT-4研究中，第26周时efsitora组与甘精胰岛素组的严重或具有临床意义的低血糖事件估计综合发生率分别为6.6（患者/年）和5.9（患者/年）。礼来计划于今年年底前向全球监管机构递交efsitora用于治疗T2DM成人患者的申请。关于QWINT系列临床试验QWINT 3期全球临床开发项目于2022年启动，该项目包括4项全球注册研究并已在全球招募了超过3,000名T2DM患者。QWINT-1 (NCT05662332) 是一项为期52周的平行设计、开放标签、治疗达标、随机对照研究，旨在比较每周一次固定剂量的基础胰岛素efsitora与甘精胰岛素在未接受过胰岛素治疗的成人T2DM患者中的有效性与安全性。该试验共纳入795名参与者，随机分配至每周一次的efsitora或每天一次的甘精胰岛素治疗组，这些参与者分别来自美国、阿根廷和墨西哥。所有接受efsitora治疗的参与者起始剂量均为100单位胰岛素，然后每4周根据需要逐步增加到150单位、250单位或400单位的固定剂量，以达到4.4-7.2mmol/L 的空腹血糖目标值。在第16周或之后，空腹血糖超过7.2mmol/L的参与者将继续转换至灵活剂量的调整。该试验的主要目的是证明第52周时efsitora对比甘精胰岛素在降低A1C水平方面的非劣效性。QWINT-3 (NCT05275400) 是一项为期78周的平行设计、开放标签、治疗达标、随机对照研究，旨在比较每周一次的基础胰岛素efsitora与德谷胰岛素在目前正在接受基础胰岛素治疗的成人T2DM患者中的有效性与安全性，并在治疗期后进行为期五周的安全性随访。该试验共纳入986名参与者，随机分配至每周一次的efsitora或每天一次的德谷胰岛素治疗组，这些参与者分别来自美国、阿根廷、匈牙利、日本、韩国、波兰、波多黎各、斯洛伐克、西班牙和中国台湾。该研究的主要目的是证明26周时 efsitora对比德谷胰岛素在降低A1C水平方面的非劣效性。QWINT-4 (NCT05462756) 是一项为期26周的平行设计、开放标签、治疗达标、随机对照研究，旨在比较每周一次的基础胰岛素efsitora与甘精胰岛素，在既往接受过基础胰岛素治疗且每天至少注射两次餐时胰岛素的成人T2DM患者中的有效性与安全性。该试验共纳入730名参与者，随机分配至每周一次的efsitora或每天一次的甘精胰岛素治疗组，两组参与者均同时使用赖脯胰岛素。这些参与者分别来自美国、阿根廷、德国、印度、意大利、墨西哥、波多黎各和西班牙。该研究的主要目的是证明26周时efsitora对比甘精胰岛素在降低A1C水平方面的非劣效性。关于efsitora alfa 胰岛素每周一次的基础胰岛素efsitora alfa (efsitora)是一种将新型胰岛素单链变体与人lgG2-Fc结构域相结合的融合蛋白。设计使用方法为每周皮下注射一次，可实现一周内较低的峰谷比和更平稳的血糖控制水平（更低的血糖变异性）。参考文献Please scroll down for more.有效性估计目标代表持续使用研究药物，且不包括起始持续严重高血糖补救治疗的所有参与者。Efsitora和甘精胰岛素治疗组参与者的 A1C基线分别为8.20%和8.28%。接受efsitora治疗的参与者起始剂量为100 单位胰岛素，之后根据需要每4周滴定为150单位、250单位和400单位的固定剂量，直至达到4.4-7.2mmol/L 的目标空腹血糖。 16周或16周后空腹血糖超过7.2mmol/L的参与者将被转换至灵活剂量的调整。Efsitora和德谷胰岛素治疗组参与者的 A1C基线均为7.80%。Efsitora和甘精胰岛素治疗组参与者的 A1C基线均为8.18%。治疗方案估计目标代表参与者的平均有效性估计，无论是否坚持使用研究药物或是否采用持续性严重高血糖的补救治疗。血糖＜3.0 mmol/L。夜间低血糖指午夜至上午6 点之间出现的任何不良事件。Lilly关于商标和商品名本文中提及的所有商标或商品名称均为礼来公司所有，若提及其他公司的商标或商品名称，其所有权则归各自所有者所有。为便于阅读，本文中提及的商标和商品名未标注®和™符号，但这并不意味着礼来公司或（在适用情况下）其他各自所有者不会在适用法律允许的最大范围内主张对这些商标和商品名的权利。我们使用或展示其他公司的商标和商品名，并非暗示与这些公司存在任何关系或意味获得这些公司的背书或赞助。Lilly关于礼来公司礼来公司是一家致力于通过科学创新改善人类健康水平，惠及全球患者的医药公司。作为医疗健康行业的领军者，礼来公司拥有近150年的历史。今天，我们的药物已帮助全球数千万人。运用生物技术、化学和基因医学的力量，我们的科学家正在积极推动新的医学进展，以应对严峻的全球健康挑战。重新定义糖尿病与肥胖疗法，减少肥胖对人体的长期影响；助力阿尔茨海默病的防治行动；为一系列威胁人类健康的免疫性疾病提供解决方案；以及将难以治愈的癌症转变为可控的疾病。礼来公司迈向健康世界的每一步，都源自于我们“致力于让数百万患者生活得更美好”的信念。这包括致力于解决全球多重挑战的创新临床试验，同时确保药物的可及性和可负担性。如果需要了解更多关于礼来公司的信息，请登录：www.lilly.com.cn。PP-MG-CN-4000

Results from the fixed-dose QWINT-1 study, along with the QWINT-3 and QWINT-4 studies, reinforce efsitora's potential to simplify insulin management with weekly dosing Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year INDIANAPOLIS, June 22, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from QWINT-1, QWINT-3, and QWINT-4 Phase 3 clinical trials evaluating the safety and efficacy of investigational once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes who used insulin for the first time, previously used daily basal insulin, and previously used daily basal insulin and mealtime insulin, respectively. In each trial, once-weekly efsitora met the primary endpoint of non-inferior A1C reduction compared to daily basal insulin. The complete results from these studies were presented at the American Diabetes Association (ADA) 85th Scientific Sessions 2025. Simultaneously, results from QWINT-1, a first-of-its-kind fixed-dose study, were published in The New England Journal of Medicine, while results from QWINT-3 and QWINT-4 were published in The Lancet. In QWINT-1, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52 for the efficacy estimand.1,2 In the trial, efsitora was titrated to four fixed doses at four-week intervals, as needed for blood glucose control.3 In QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec at week 26 for the efficacy estimand.4 In QWINT-4, efsitora reduced A1C by 1.07% compared to 1.07% for insulin glargine at week 26 for the efficacy estimand.5 In these two trials, efsitora was administered using traditional insulin dosing with adjustments based on each patient's glucose level. "The novel fixed-dose regimen used in QWINT-1 for once-weekly efsitora, which consisted of only four single-dose titration options, has the potential to facilitate and simplify insulin therapy, reducing the hesitation often associated with starting insulin to treat type 2 diabetes," said Dr. Julio Rosenstock, senior scientific advisor for Velocity Clinical Research at Medical City Dallas, clinical professor of medicine, University of Texas Southwestern Medical Center, and lead trial investigator for QWINT-1. "A simpler, once-weekly regimen with efsitora may help people with type 2 diabetes initiate and manage insulin therapy with the goal of improving blood sugar levels. Across all QWINT trials, the results showed that once-weekly efsitora controlled glucose as effectively as the most popular once-daily basal insulins." "Building on Lilly's legacy of innovation in insulin therapy, once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year," said Jeff Emmick, M.D., Ph.D., senior vice president of product development at Lilly. "These results reinforce the potential for once-weekly efsitora to help reduce the overall burden of insulin therapy through a simplified treatment approach. We look forward to working with regulatory agencies to bring this innovation to patients around the world." Across the three trials, efsitora demonstrated an overall safety profile similar to two of the most commonly used daily basal insulin therapies for the treatment of type 2 diabetes. In QWINT-1, efsitora resulted in approximately 40% fewer hypoglycemic events compared to insulin glargine, with estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure of 0.50 with efsitora vs. 0.88 with insulin glargine at 52 weeks. In QWINT-3, these rates were 0.84 with efsitora vs. 0.74 with insulin degludec at 78 weeks. In QWINT-4, estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure were 6.6 with efsitora vs. 5.9 with insulin glargine at 26 weeks. Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year. About the QWINT clinical trial program The QWINT Phase 3 global clinical development program for insulin efsitora alfa (efsitora) in diabetes began in 2022 and has enrolled more than 3,000 people living with type 2 diabetes across four global registration studies. QWINT-1 (NCT05662332) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin using a fixed dose escalation to daily insulin glargine for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 795 participants across the U.S., Argentina and Mexico to receive efsitora once weekly or insulin glargine once daily, administered subcutaneously. Participants treated with efsitora received a starting dose of 100 units of insulin, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every four weeks, as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose greater than 130 mg/dL on or after 16 weeks were transferred to flexible dosing. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to daily use of insulin glargine. QWINT-3 (NCT05275400) was a multicenter, randomized, parallel-design, open-label trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 78 weeks after a three-week lead-in followed by a five-week safety follow up period, in adults with type 2 diabetes who are currently treated with basal insulin. The trial randomized 986 participants across the U.S., Argentina, Hungary, Japan, Korea, Poland, Puerto Rico, Slovakia, Spain and Taiwan to receive efsitora once weekly or insulin degludec once daily, administered subcutaneously. The primary objective of the study was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin degludec. QWINT-4 (NCT05462756) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a weekly basal insulin to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin. The trial randomized 730 participants across the U.S., Argentina, Germany, India, Italy, Mexico, Puerto Rico and Spain to receive efsitora once weekly or insulin glargine once daily, both of which were administered subcutaneously along with insulin lispro. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin glargine. About insulin efsitora alfa Insulin efsitora alfa (efsitora) is a once-weekly basal insulin, a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain. It is specifically designed for once-weekly subcutaneous administration, and with its low peak-to-trough ratio, it has the potential to provide more stable glucose levels (less glucose variability) throughout the week. 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 The efficacy estimand represents the treatment effect on all participants who adhered to the study drug without initiating rescue therapy for persistent severe hyperglycemia. From a baseline of 8.20% for efsitora and 8.28% for insulin glargine. Participants treated with efsitora received a starting dose of 100 units of insulin, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every four weeks, as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose greater than 130 mg/dL on or after 16 weeks were transferred to flexible dosing. From a baseline of 7.80% for both efsitora and insulin degludec. From a baseline of 8.18% for both efsitora and insulin glargine. The treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation or introduction of rescue therapy for persistent severe hyperglycemia. Blood glucose <54 mg/dL. Nocturnal hypoglycemia was defined as any event that occurred at night between midnight and 6 a.m. 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 insulin efsitora alfa as a potential treatment for people with type 2 diabetes and the timeline for future readouts, presentations, and other milestones relating to insulin efsitora alfa 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 future study results will be consistent with study results to date, that insulin efsitora alfa will prove to be a safe and effective treatment for type 2 diabetes, that insulin efsitora alfa will receive regulatory approval, 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. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. SOURCE Eli Lilly and Company WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED