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

固定剂量的 QWINT-1 研究以及 QWINT-3 和 QWINT-4 研究的结果进一步证实了 efsitora 通过每周一次给药简化胰岛素管理的潜力。

Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year

礼来计划在今年年底前向全球监管机构提交 efzitora 用于治疗成人2型糖尿病的申请。

INDIANAPOLIS

印第安纳波利斯

,

，

June 22, 2025

2025年6月22日

/PRNewswire/ --

/PRNewswire/ --

Eli Lilly and Company

礼来公司

(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.

(NYSE: LLY) 今天公布了 QWINT-1、QWINT-3 和 QWINT-4 三项 III 期临床试验的详细结果，这些试验评估了研究性每周一次的胰岛素 efsitora alfa（efsitora）在首次使用胰岛素、既往使用每日基础胰岛素、以及既往使用每日基础胰岛素和餐时胰岛素的成人 2 型糖尿病患者中的安全性和有效性。

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 .

在每次试验中，每周一次的Efsitora达到了与每日基础胰岛素相比A1C降低非劣效性的主要终点。这些研究的完整结果在会议上公布。

American Diabetes Association

美国糖尿病协会

(ADA) 85

(ADA) 85

th

泰国

Scientific Sessions 2025. Simultaneously, results from QWINT-1, a first-of-its-kind fixed-dose study, were published in

2025年科学会议。同时，首个固定剂量研究QWINT-1的结果已发表在

The New England Journal of Medicine

《新英格兰医学杂志》

, while results from QWINT-3 and QWINT-4 were published in

，而 QWINT-3 和 QWINT-4 的结果则发布在

The Lancet

《柳叶刀》

.

。

In QWINT-1, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52 for the efficacy estimand.

在QWINT-1试验中，就第52周的有效性估计值而言，efsitora将A1C降低了1.31%，而甘精胰岛素则降低了1.27%。

1,2

1,2

In the trial, efsitora was titrated to four fixed doses at four-week intervals, as needed for blood glucose control.

在试验中，根据血糖控制的需要，依非那酮每四周调整至四个固定剂量。

3

3

In QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec at week 26 for the efficacy estimand.

在QWINT-3中，就第26周的有效性估计值而言，efistora使A1C降低了0.86%，而胰岛素degludec降低了0.75%。

4

4

In QWINT-4, efsitora reduced A1C by 1.07% compared to 1.07% for insulin glargine at week 26 for the efficacy estimand.

在QWINT-4研究中，就第26周的有效性估计值而言，efsiotora与甘精胰岛素相比，A1C降低了1.07%。

5

5

In these two trials, efsitora was administered using traditional insulin dosing with adjustments based on each patient's glucose level.

在这两项试验中，Efsitora 是根据每位患者的血糖水平，采用传统胰岛素剂量调整方式进行给药的。

'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.

“QWINT-1 研究中用于每周一次 efsitora 的新型固定剂量方案，仅包含四种单剂量滴定选择，有可能促进和简化胰岛素治疗，减少通常与开始使用胰岛素治疗 2 型糖尿病相关的犹豫，”博士表示。

Julio Rosenstock

朱利奥·罗森斯托克

, senior scientific advisor for

，高级科学顾问

Velocity Clinical Research

速度临床研究

at Medical City Dallas, clinical professor of medicine,

在达拉斯医学城，医学临床教授，

University of Texas Southwestern Medical Center

德克萨斯大学西南医学中心

, 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.'.

，QWINT-1 的主要试验研究者。“使用艾夫西托拉的更简单的每周一次方案可能帮助 2 型糖尿病患者开始和管理胰岛素治疗，以达到改善血糖水平的目标。在所有 QWINT 试验中，结果显示每周一次的艾夫西托拉控制葡萄糖的效果与最流行的每日一次基础胰岛素一样有效。”

QWINT-1 Primary Endpoint

QWINT-1 主要终点指标

Efficacy Estimand

疗效估计值

Treatment-Regimen

治疗方案

Estimand

估计量

6

6

Primary Endpoint – A1C Reduction (Resulting A1C) at Week 52

主要终点 - 第52周A1C降低（最终A1C结果）

Efsitora

埃夫西托拉

-1.31 % (6.92 %)

-1.31 % （6.92 %）

-1.19 % (7.05 %)

-1.19 % (7.05 %)

Glargine

甘精胰岛素

-1.27 % (6.96 %)

-1.27 % (6.96 %)

-1.16 % (7.08 %)

-1.16 % (7.08 %)

QWINT-3 Primary and Key Secondary Endpoints

QWINT-3 主要和关键次要终点指标

Efficacy Estimand

疗效估计值

Treatment-Regimen

治疗方案

Estimand

估计值

Primary Endpoint – A1C Reduction (Resulting A1C) at Week 26

主要终点 - 第26周A1C降低（最终A1C结果）

Efsitora

埃夫西托拉

-0.86 % (6.93 %)

-0.86 % (6.93 %)

-0.81 % (6.99 %)

-0.81 % (6.99 %)

Degludec

德谷胰岛素

-0.75 % (7.03 %)

-0.75 % (7.03 %)

-0.72 % (7.08 %)

-0.72 % (7.08 %)

Key Secondary Endpoint – Rates of Clinically Significant or Severe Nocturnal

关键次要终点 - 临床显著或严重夜间发生率

Hypoglycemic Events Per Patient-Year of Exposure up to Week 78

每位患者年暴露至第78周的低血糖事件数

7,8

7,8

Efsitora

埃夫西托拉

0.11

0.11

Degludec

德谷胰岛素

0.10

0.10

Key Secondary Endpoint – Percent Time in Range (70-180 mg/dL) During the Four

关键次要终点 – 在四个时间段内血糖范围（70-180 mg/dL）的百分比

Weeks Prior to Week 26

第26周之前的几周

Efsitora

埃夫西托拉

62.8 %

62.8 %

61.4 %

61.4 %

Degludec

德谷胰岛素

61.3 %

61.3 %

61.0 %

61.0 %

QWINT-4 Primary and Key Secondary Endpoints

QWINT-4 主要和关键次要终点指标

Efficacy Estimand

有效性估计值

Treatment-Regimen

治疗方案

Estimand

估计量

Primary Endpoint – A1C Reduction (Resulting A1C) at Week 26

主要终点 – 第26周A1C降低（结果A1C）

Efsitora

埃夫西托拉

-1.07 % (7.12 %)

-1.07 % (7.12 %)

-1.01 % (7.17 %)

-1.01 % (7.17 %)

Glargine

甘精胰岛素

-1.07 % (7.11 %)

-1.07 % (7.11 %)

-1.00 % (7.18 %)

-1.00 % (7.18 %)

Key Secondary Endpoint – Participants Achieving A1C <7% at Week 26 Without

关键次要终点 – 在第26周达到A1C <7%的参与者数量，且无

Nocturnal Hypoglycemia

夜间低血糖

Efsitora

埃夫西托拉

39.5 %

39.5 %

38.6 %

38.6 %

Glargine

甘精胰岛素

36.6 %

36.6 %

35.9 %

35.9 %

Key Secondary Endpoint – Rates of Clinically Significant or Severe Nocturnal

关键次要终点 - 临床显著或重度夜间发生率

Hypoglycemic Events Per Patient-Year of Exposure up to Week 26

每位患者年至第26周的低血糖事件发生率

Efsitora

埃夫西托拉

0.67

0.67

Glargine

甘精胰岛素

1.00

1.00

'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

“基于礼来公司在胰岛素治疗领域的创新传统，每周一次的Efsitora可能为需要胰岛素的2型糖尿病患者带来重大进步，每年可减少300多次注射。”

Jeff Emmick

杰夫·埃米克

, 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.'.

医学博士、礼来公司产品开发高级副总裁表示：“这些结果进一步证实了一周一次的Efsitora有望通过简化的治疗方案帮助减轻胰岛素治疗的整体负担。我们期待与监管机构合作，将这一创新带给世界各地的患者。”

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.

在三项试验中，efsitora 表现出与两种最常用的每日基础胰岛素疗法相似的整体安全性，用于治疗 2 型糖尿病。在 QWINT-1 中，与甘精胰岛素相比，efsitora 导致的低血糖事件减少了约 40%，每患者年的严重或临床显著低血糖事件的估计合并发生率为 0.50（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..

在 QWINT-3 中，这些比率在 78 周时为：使用 efsitora 为 0.84，而使用甘精胰岛素为 0.74。在 QWINT-4 中，每患者年的严重或临床显著低血糖事件的估计综合发生率在 26 周时为：使用 efsitora 为 6.6，而使用甘精胰岛素为 5.9。

Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year.

礼来计划在今年年底前向全球监管机构提交 efzitora 用于治疗成人2型糖尿病的申请。

About the QWINT clinical trial program

关于QWINT临床试验计划

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.

胰岛素Efsitora Alfa（Efsitora）在糖尿病领域的QWINT第三阶段全球临床开发计划于2022年开始，并在全球四个注册研究中招募了超过3000名2型糖尿病患者。

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.

QWINT-1（NCT05662332）是一项平行设计、开放标签、目标治疗的随机对照临床试验，比较了每周一次固定剂量递增的Efsitora作为基础胰岛素与每日一次甘精胰岛素在未曾使用胰岛素的成人2型糖尿病患者中持续52周的疗效和安全性。

The trial randomized 795 participants across the .

试验随机选取了795名参与者。

U.S.

美国

,

，

Argentina

阿根廷

and

和

Mexico

墨西哥

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.

每周一次皮下注射efsitora或每日一次皮下注射甘精胰岛素。接受efsitora治疗的参与者起始剂量为100单位胰岛素，随后根据需要每四周逐步增加至固定剂量150单位、250单位和400单位，直至达到目标空腹血糖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..

在16周或之后空腹血糖大于130 mg/dL的参与者被转移到灵活剂量。试验的主要目的是证明与每天使用甘精胰岛素相比，efsitora在第52周降低A1C方面的非劣效性。

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.

QWINT-3（NCT05275400）是一项多中心、随机、平行设计、开放标签试验，比较了efsitora作为每周一次的基础胰岛素与德谷胰岛素在成人2型糖尿病患者中的疗效和安全性；这些患者目前正接受基础胰岛素治疗。试验包括三周导入期，随后进行为期78周的治疗以及五周的安全性随访期。

The trial randomized 986 participants across the .

试验随机选取了986名参与者。

U.S.

美国

,

，

Argentina

阿根廷

,

，

Hungary

匈牙利

,

，

Japan

日本

,

，

Korea

韩国

,

，

Poland

波兰

,

，

Puerto Rico

波多黎各

,

，

Slovakia

斯洛伐克

,

，

Spain

西班牙

and

和

Taiwan

台湾

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.

每周一次接受efsitora或每天一次接受胰岛素degludec，通过皮下注射给药。该研究的主要目的是证明在第26周时，与胰岛素degludec相比，efsitora在降低A1C方面的非劣效性。

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.

QWINT-4（NCT05462756）是一项平行设计、开放标签、目标治疗的随机对照临床试验，比较了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和每日至少两次餐时胰岛素治疗的成人2型糖尿病患者中的疗效和安全性，持续26周。

The trial randomized 730 participants across the .

试验随机分配了730名参与者。

U.S.

美国

,

，

Argentina

阿根廷

,

，

Germany

德国

,

，

India

印度

,

，

Italy

意大利

,

，

Mexico

墨西哥

,

，

Puerto Rico

波多黎各

and

和

Spain

西班牙

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.

每周一次接受efsitora或每天一次接受甘精胰岛素，这两种药物均通过皮下注射与赖脯胰岛素联合使用。试验的主要目的是证明在第26周时，与甘精胰岛素相比，efsitora在降低A1C方面的非劣效性。

About insulin efsitora alfa

关于胰岛素 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..

胰岛素 efsitora alfa（efsitora）是一种每周一次的基础胰岛素，是一种融合蛋白，结合了新型的单链胰岛素变体和人 IgG2 Fc 结构域。它专为每周一次的皮下注射设计，由于其较低的峰谷比，有可能在一周内提供更稳定的血糖水平（减少血糖波动）。

About Lilly

关于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.

礼来是一家医药公司，将科学转化为治疗手段，以改善世界各地人们的生活。近150年来，我们一直致力于开创改变生命的发现，如今我们的药物帮助了全球数千万人。通过利用生物技术、化学和基因医学的力量，我们的科学家正在加速推进新的发现，以解决一些全球最重要的健康挑战：重新定义糖尿病护理；治疗肥胖症并遏制其最具破坏性的长期影响；推动对抗阿尔茨海默病的斗争；为一些最严重的免疫系统疾病提供解决方案；并将最难治疗的癌症转化为可管理的疾病。

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 .

每迈向更健康的世界一步，我们都被一个目标所驱动：让数百万人的生活更美好。这包括开展反映世界多样性的创新临床试验，并努力确保我们的药物可及且负担得起。欲了解更多信息，请访问。

Lilly.com

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and

和

Lilly.com/news

Lilly.com/新闻

, or follow us on

，或者关注我们

Facebook

Facebook

,

，

Instagram

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, and

，以及

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. P-LLY

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The efficacy estimand represents the treatment effect on all participants who adhered to the study drug without initiating rescue therapy for persistent severe hyperglycemia.

疗效估计值代表了对所有坚持研究药物且未因持续严重高血糖而开始救援治疗的参与者的治疗效果。

From a baseline of 8.20% for efsitora and 8.28% for insulin glargine.

从8.20%的efsitora和8.28%的甘精胰岛素的基础值开始。

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..

接受Efsitora治疗的参与者起始剂量为100单位胰岛素，随后根据需要每四周逐步增加至固定剂量150单位、250单位和400单位，直至达到目标空腹血糖80-130 mg/dL。在第16周或之后空腹血糖高于130 mg/dL的参与者转为灵活剂量调整。

From a baseline of 7.80% for both efsitora and insulin degludec.

从7.80%的基线开始，efsitora和德谷胰岛素均是如此。

From a baseline of 8.18% for both efsitora and insulin glargine.

从8.18%的基线开始，efsitora和甘精胰岛素都是如此。

The treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation or introduction of rescue therapy for persistent severe hyperglycemia.

治疗方案估计量代表了估计的平均治疗效果，无论是否停止治疗或因持续严重高血糖引入补救疗法。

Blood glucose <54 mg/dL.

血糖 <54 mg/dL。

Nocturnal hypoglycemia was defined as any event that occurred at night

夜间低血糖被定义为夜间发生的任何事件。

between midnight and 6 a.m.

凌晨十二点到六点之间

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性声明的警示性声明

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.

本新闻稿包含关于胰岛素 efsitora alfa 作为 2 型糖尿病患者潜在治疗方案的前瞻性声明（该术语定义见 1995 年《私人证券诉讼改革法案》），以及与胰岛素 efsitora alfa 及其临床试验相关的未来数据发布、展示和其他里程碑的时间表，反映了礼来公司当前的信念和期望。

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.

然而，与任何医药产品一样，在药物研发、开发和商业化的过程中存在重大风险和不确定性。其中，无法保证未来的研究结果会与迄今为止的研究结果一致，无法保证胰岛素Efsitora Alfa将成为治疗2型糖尿病的安全有效方法，无法保证胰岛素Efsitora Alfa将获得监管机构的批准，也无法保证礼来公司将如期执行其战略。

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 .

有关这些风险和其他可能导致实际结果与礼来公司预期不同的不确定性的进一步讨论，请参阅礼来公司向美国证券交易委员会提交的Form 10-K和Form 10-Q报告。

United States Securities and Exchange Commission

美国证券交易委员会

. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

除非法律要求，礼来公司没有义务更新前瞻性声明以反映本发布日期之后的事件。

Trademarks and

商标和

Trade Names

商品名称

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.

本新闻稿中提到的所有商标或商号均为公司财产，或者，若涉及属于其他公司的商标或商号，则为其各自所有者的财产。仅为方便起见，本新闻稿中提及的商标和商号未加®和™符号，但此类引用不应被解释为表明公司或在适用的情况下其各自所有者不会根据适用法律最大限度地主张公司或其对该等权利的所有权。

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..

我们无意使用或展示其他公司的商标和商号来暗示我们与其他公司存在关系，或得到其他公司的认可或赞助。

Refer to:

参考：

Niki Biro

尼基·比罗

;

；

niki_biro@lilly.com

尼基·比罗@礼来公司.com

; 317-358-9074 (Media)

；317-358-9074（媒体）

Michael Czapar

迈克尔·察帕尔

;

；

czapar_michael_c@lilly.com

czapar_michael_c@lilly.com

; 317-617-0983 (Investors)

；317-617-0983（投资者）

View original content to download multimedia:

查看原始内容以下载多媒体：

https://www.prnewswire.com/news-releases/lillys-once-weekly-insulin-efsitora-alfa-demonstrated-a1c-reduction-and-a-safety-profile-consistent-with-daily-insulin-in-multiple-phase-3-trials-302487669.html

https://www.prnewswire.com/news-releases/礼来每周一次的胰岛素Efsitora-alfa在多项3期试验中显示出与每日胰岛素一致的A1C降低效果和安全性-302487669.html

SOURCE

源代码

Eli Lilly and Company

礼来公司