礼来公司的实验性口服药片显示出减肥效果，但存在挥之不去的副作用担忧-动脉网

Eli Lilly's Investigational Oral Pill Shows Weight Loss Benefits With Lingering Side Effect Concerns

benzinga 等信源发布 2025-06-23 07:45

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Eli Lilly And Co

礼来公司

LLY

礼来公司

on Saturday announced detailed results from the ACHIEVE-1 Phase 3 trial of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with

周六宣布了与安慰剂相比，orforglipron在血糖控制不佳的成人2型糖尿病患者中进行的ACHIEVE-1 III期试验的详细结果。

diet and exercise alone

饮食和运动 alone

。

The company released its topline data

公司发布了其顶线数据

from the trial in April

从四月的试验中

。

At 40 weeks, all three doses (3 mg, 12 mg, 36 mg) of orforglipron achieved the primary endpoint of superior A1C reduction.

在40周时，orforglipron的三种剂量（3毫克、12毫克、36毫克）均达到了主要终点，即A1C显著降低。

Also Read:

另请阅读：

Eli Lilly’s $1.3 Billion Verve Deal Signals Confidence In Gene Editing Space: Analyst

礼来公司13亿美元的Verve交易显示出对基因编辑领域的信心：分析师

In addition, the 12 mg and 36 mg doses showed clinically meaningful and statistically significant reductions in

此外，12毫克和36毫克剂量显示出具有临床意义且统计学上显著的减少。

body weight vs. placebo

体重与安慰剂对比

。

In the study, orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by 1.3% to 1.6% from a baseline of 8.0% for the efficacy estimand.

在该研究中，orforglipron 在 40 周时相比安慰剂达到了主要终点，即 A1C 显著降低，从基线 8.0% 的水平将 A1C 降低了 1.3% 至 1.6%（疗效估计值）。

In key secondary endpoints, up to 76.2% of participants taking orforglipron achieved the ADA treatment target A1C of <7%, 66.0% achieved an A1C of ≤6.5%, and 25.8% achieved <5.7%, defined as a normal A1C value.

在关键的次要终点中，多达 76.2% 的服用 orforglipron 的参与者达到了美国糖尿病协会 (ADA) 的 A1C <7% 的治疗目标，66.0% 达到了 A1C ≤6.5%，25.8% 达到了 <5.7%，被定义为正常的 A1C 值。

Improvements in A1C were observed as early as four weeks and were accompanied by similar reductions in fasting serum glucose.

A1C的改善最早在四周时就被观察到，并且伴随着空腹血糖的类似降低。

In another key secondary endpoint, participants taking the highest dose of orforglipron lost an average of 16.0 lbs (7.9%).

在另一个关键的次要终点上，服用最高剂量orforglipron的参与者平均减重16.0磅（7.9%）。

While participants in ACHIEVE-1 did not appear to reach a weight plateau, longer-duration trials, such as the ATTAIN trials, will provide a comprehensive evaluation of the safety and efficacy of orforglipron for obesity.

虽然ACHIEVE-1的参与者似乎并未达到体重平台期，但更长时间的试验（如ATTAIN试验）将对orforglipron治疗肥胖的安全性和有效性进行全面评估。

While the tolerability profile was in line with the incretin class,

虽然其耐受性特征与肠促胰素类药物一致，

William Blair

威廉·布莱尔

highlights that at the highest dose, nausea, vomiting, and constipation did not appear to subside over time, in contrast with its peptide GLP-1 receptor agonist counterparts.

最高剂量下，恶心、呕吐和便秘似乎并没有随着时间的推移而减轻，这与其肽类GLP-1受体激动剂不同。

“We are less bullish about the prospects of orforglipron in this setting for two reasons: early plateauing and persistent side effects,” said analyst

“我们对orforglipron在这种环境下的前景不太乐观，原因有两个：早期平台期和持续的副作用，”分析师表示。

Andy Hsieh

谢安迪

。

Once-Weekly Insulin Efsitora

每周一次胰岛素 Efsitora

In addition to the orforglipron data, Eli Lilly also shared promising results for its investigational once-weekly insulin, efsitora.

除了orforglipron的数据，礼来公司还分享了其在研的每周一次的胰岛素efsitora的可喜成果。

On Sunday, Eli Lilly announced detailed results from QWINT-1, QWINT-3, and QWINT-4 Phase 3 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 .

礼来公司周日公布了 QWINT-1、QWINT-3 和 QWINT-4 三项三期临床试验的详细结果，这些试验评估了在首次使用胰岛素、之前使用每日基础胰岛素和之前使用每日基础胰岛素的 2 型糖尿病成人患者中，每周一次的在研胰岛素 efsitora alfa（efsitora）的安全性和有效性。

and mealtime insulin, respectively

分别是餐时胰岛素

。

Eli Lilly released topline results from the QWINT-1 and QWINT-3 trials

礼来公司发布了QWINT-1和QWINT-3试验的顶线结果。

in September 2024

2024年9月

。

In each trial, once-weekly efsitora met the primary endpoint of non-inferior A1C reduction compared to daily basal insulin.

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非劣效的A1C降低主要终点。

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 中，就疗效估计值而言，efistora 在第 52 周时将 A1C 降低了 1.31%，而甘精胰岛素则降低了 1.27%。

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，依非西他拉被滴定为四个固定剂量，每隔四周调整一次。

In QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec at week 26 for the efficacy estimand. In QWINT-4, efsitora reduced A1C by 1.07% compared to 1.07% for insulin glargine.

在 QWINT-3 中，就第 26 周的有效性估计值而言，efsiotora 将 A1C 降低了 0.86%，而德谷胰岛素降低了 0.75%。在 QWINT-4 中，efsiotora 将 A1C 降低了 1.07%，甘精胰岛素也降低了 1.07%。

Lilly plans to submit efsitora for 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。

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.

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%，估计每患者年的严重或临床上显著的低血糖事件发生率在efsitora组为0.50，而甘精胰岛素组为0.88（在52周时）。在QWINT-3中，这些比率分别为efsitora组0.84 vs. 甘精胰岛素组。

0.74 with insulin degludec at 78 weeks..

0.74，胰岛素degludec在78周时。

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-4 中，efsitora 的严重或临床显著低血糖事件的估计合并发生率为每位患者每年 6.6 次，而甘精胰岛素在 26 周时为 5.9 次。

Across the three trials, efsitora demonstrated an overall safety profile similar to two of the most commonly used daily basal insulin therapies for type 2 diabetes.

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总体安全性。

Price Action:

价格行为:

LLY stock is trading lower by 0.19% to $761.25 premarket at last check Monday.

LLY股票在周一早盘交易中下跌0.19%，至761.25美元。

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