Tirzepatide, a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GLP-1 RA), has shown superior efficacy in glycemic control, weight loss, and cardiometabolic outcomes compared to GLP-1 RAs alone. While GLP-1 RAs may offer neuroprotective effects relevant to glaucoma, the impact of dual-incretin therapies like tirzepatide on glaucoma remains unknown. This study investigates the association between tirzepatide initiation and the risk of primary open-angle glaucoma (POAG), ocular hypertension (OHTN), and glaucoma treatment initiation in patients with type 2 diabetes mellitus (T2DM), compared to those initiating selective GLP-1 RAs.

DESIGN:

Retrospective clinical cohort study using a nationwide electronic health records network from June 2022 to May 2025.

SUBJECTS:

Adults with T2DM who initiated tirzepatide or selective GLP-1 RA therapy. Patients with prior exposure to either drug class, recent addition of second-line antihyperglycemic agents, previous glaucoma diagnosis or surgery, or ocular trauma were excluded.

METHODS:

Data from 71 U.S. healthcare organizations were analyzed. Propensity score matching (1:1) was conducted to balance cohorts for demographics, comorbidities, medication use, and ophthalmic encounters. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated for each outcome.

MAIN OUTCOME MEASURES:

Incidence of POAG, OHTN, and first-line glaucoma treatments (medications or surgery).

RESULTS:

We identified 41,850 patients who initiated tirzepatide and 147,828 patients who initiated selective GLP-1 RAs. After matching, 41,849 patients remained in each cohort. Tirzepatide use was associated with a significantly lower risk of POAG (RR 0.50, 95% CI 0.34-0.74), OHTN (RR 0.59, 95% CI 0.40-0.88), and need for glaucoma treatment (RR 0.54, 95% CI 0.45-0.64) compared to selective GLP-1 RAs. Risk reductions persisted in subgroups with concomitant metformin or insulin use. Sensitivity analyses limited to patients aged ≥60 years and comparisons with individual GLP-1 RAs (semaglutide and dulaglutide) yielded consistent trends.

CONCLUSIONS:

Tirzepatide use was associated with a significantly reduced risk of developing POAG, OHTN, and need for first-line glaucoma treatment compared to selective GLP-1 RAs in patients with T2DM. These findings suggest a potential additional ocular benefit of tirzepatide and support further investigation into its role in glaucoma management.

2026-02-01·INTERNATIONAL JOURNAL OF CARDIOLOGY

Early glucagon-like peptide-1 receptor agonist use after myocardial infarction in patients with type 2 diabetes

Article

作者: Ahmad, Omar ; Ibrahim, Ramzi ; Abdelnabi, Mahmoud ; Al-Kindi, Sadeer ; Elbenawi, Hossam ; Nasir, Khurram ; Fortuin, F David ; Sell-Dottin, Kristen A ; Farina, Juan ; Yang, Eric H ; Simper, David ; Bhakta, Mayurkumar D ; Lee, Kwan ; Arsanjani, Reza ; Pham, Hoang Nhat ; Salih, Mohammed ; Sweeney, John P ; Ayoub, Chadi

AIMS:

Acute myocardial infarction (AMI) is among the leading causes of mortality in patients with type 2 diabetes (T2DM). This study evaluated whether initiation of glucagon-like peptide-1 receptor agonists (GLP1RAs) post-AMI improves cardiovascular outcomes in this population.

METHODS:

This retrospective cohort study used the TriNetX Research Network to identify adult patients with T2DM who experienced an AMI between January 1, 2017, and December 31, 2023. Patients were included if they initiated tirzepatide or semaglutide within 14 days post-AMI. Propensity score matching (PSM) was performed to balance baseline characteristics. The primary outcome was recurrent coronary events, and secondary outcomes included all-cause mortality and hospitalizations, heart failure (HF) hospitalizations, acute kidney injury (AKI), and cardiac arrest. Hazard ratios (HR) were estimated using Cox proportional hazard models.

RESULTS:

5338 patients were included in each cohort. Mean follow-up was 327.7 days (GLP1RA group) vs. 307.9 days (non-GLP1RA group). GLP1RA use did not significantly reduce recurrent coronary events (3.7 % vs 3.8 %; HR 0.913, 95 % CI 0.750-1.111). GLP1RA use was associated with significantly lower all-cause mortality (HR 0.484, 95 % CI 0.413-0.567), HF hospitalizations (HR 0.578, 95 % CI 0.531-0.630), AKI (HR 0.688, 95 % CI 0.610-0.732), cardiac arrest (HR 0.549, 95 % CI 0.418-0.722), and all-cause hospitalizations (HR 0.673, 95 % CI 0.636-0.713).

CONCLUSIONS:

GLP1RA initiation in patients with T2DM post-AMI was not associated with a reduction in recurrent coronary events, but was linked to improvements in other cardiovascular outcomes, suggesting a potential role for GLP1RAs as part of a secondary prevention strategy.

2026-02-01·HYPERTENSION

CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1

Article

作者: Rubino, Domenica ; Sharma, Arya M. ; Sbraccia, Paolo ; Dicker, Dror ; Verma, Subodh ; Garvey, W. Timothy ; Sørrig, Rasmus ; Smedegaard, Lærke ; Böttcher, Morten ; Brown, Paul

BACKGROUND::

Fixed-dose combination of semaglutide/cagrilintide (CagriSema 2.4 mg/2.4 mg) has demonstrated significant and clinically relevant body weight reductions in adults with overweight or obesity compared with placebo.

METHODS::

The phase 3a, 68-week REDEFINE 1 trial randomized adults without diabetes with body mass index ≥30 kg/m 2 , or ≥27 kg/m 2 with ≥1 obesity-related complication, to once-weekly CagriSema 2.4 mg/2.4 mg, semaglutide 2.4 mg, cagrilintide 2.4 mg, or placebo, plus lifestyle intervention. Secondary and post hoc analyses evaluated the antihypertensive effect from REDEFINE 1, focusing on CagriSema and placebo groups, by subgroup/category, including baseline body mass index, the presence of hypertension or resistant hypertension at baseline, and concomitant changes in the use of antihypertensive medications.

RESULTS::

Overall, 3417 participants underwent randomization; CagriSema: n=2108, semaglutide: n=302, cagrilintide: n=302, and placebo: n=705. Changes from baseline to week 68 in blood pressure (BP) were greater with CagriSema versus placebo (systolic BP: –10.9 versus –2.8 mm Hg; diastolic BP: –5.4 versus –1.7 mm Hg, respectively). The proportion of participants reaching BP targets at week 68 was 63.0% and 32.0% for CagriSema and placebo, respectively. The proportion of participants with resistant hypertension at baseline (n=167) that reached BP targets at week 68 was 42.0% and 29.3% for CagriSema and placebo, respectively (odds ratio, 1.7 [95% CI, 0.7–4.4]). Among participants who used antihypertensive medication during the study, 39.6% in the CagriSema group decreased or stopped treatment from week 0 to week 68 versus 18.8% with placebo.

CONCLUSIONS::

CagriSema presents clinically relevant reductions in BP across a wide range of participant subgroups, including those with resistant hypertension.

REGISTRATION::

URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05567796.

项与 Semaglutide(Vivani Medical) 相关的新闻（医药）

2026-01-14

·国际糖尿病idiabetes

站上心肾代谢的主舞台——2025口服司美格鲁肽年度进展盘点

点击“蓝字”关注我们编者按 2025年是口服胰高糖素样肽-1受体激动剂（GLP-1RA）司美格鲁肽片证据全面爆发与临床价值深刻变革的一年，从里程碑式的心血管结局研究（CVOT）SOUL结果公布，再到贯穿全年的多项重磅亚组分析、真实世界证据及各大国际学术会议的深度解析，持续刷新着我们对2型糖尿病（T2DM）管理的认知。本文系统梳理2025年度围绕司美格鲁肽片的重要进展，从临床疗效、心肾获益、特殊人群应用及临床实践影响等多维度进行盘点，以期为临床医生提供清晰的年度回顾与未来展望。一、疗效基石：系统梳理PIONEER系列中国数据与全球真实世界证据司美格鲁肽片的强效降糖与多重代谢获益已在Ⅲ期PIONEER系列临床研究中获得充分证实[1-12]。2025年，本刊对相关证据进行了系统梳理（图1）。其中，PIONEER 11和PIONEER 12研究预设中国亚组分析表明，司美格鲁肽片14 mg在中国T2DM患者中可实现高达1.6%的HbA1c降幅，HbA1c达标率（<7%）高达92.3%，体重降幅高达3.4 kg，疗效显著优于安慰剂及活性对照药西格列汀[11,12]。这为中国临床实践中使用司美格鲁肽片提供了直接且高级别的证据支持。图1. PIONEER系列研究：司美格鲁肽片强效降糖、显著减重、兼具降压调脂，安全性良好，中国人群获益与全球数据一致与此同时，多项PIONEER REAL真实世界研究结果相继发表，进一步在全球范围内验证了司美格鲁肽片在常规临床实践中的疗效与安全性。其中，来自瑞士、荷兰、瑞典、日本、英国、意大利及西班牙等国的数据显示，在未使用过注射降糖药的成人T2DM患者中，起始司美格鲁肽片治疗34~44周后，HbA1c降幅最高达1.4%，体重降幅最高达7.19 kg（图2），且医生评估的治疗成功率及患者报告的治疗满意度亦显著提升[13-20]。这些真实世界证据进一步将司美格鲁肽片的疗效从严格受控的试验环境拓展至纷繁复杂的日常诊疗。图2. PIONEER REAL系列研究：真实世界中，司美格鲁肽片降糖、减重幅度最高达1.4%、7.19 kg — 相关阅读 — 迈向GLP-1RA口服新时代——对话主要研究者Martin Haluzík教授突破之钥，控糖之果——司美格鲁肽片引领T2DM全程管理新纪元惊艳回响：从RCT到RWE，司美格鲁肽片最新数据的前沿解析 | CDS 2025 二、里程碑突破：SOUL研究重磅揭晓，确证司美格鲁肽片心血管保护优效性 2025年3月，心血管代谢领域取得里程碑式进展——司美格鲁肽片的CVOT研究SOUL完整结果于美国心脏病学会（ACC）科学年会上重磅公布，并同步发表于《新英格兰医学杂志》[21]。该研究首次为司美格鲁肽片的心血管保护作用提供了最高级别的循证医学证据。 SOUL研究是一项国际多中心、随机、双盲、安慰剂对照试验，共纳入9650例T2DM合并动脉粥样硬化性心血管疾病（ASCVD）和/或慢性肾脏病（CKD）患者。研究采用优效性设计，经过中位49.5个月随访，成功达到主要终点：与安慰剂相比，司美格鲁肽片显著降低主要心血管不良事件（MACE，包括心血管死亡、非致死性心肌梗死和非致死性卒中）风险达14%（P=0.006），且各组分事件呈一致性下降趋势，其中非致死性心肌梗死风险降低尤为显著，降幅达26%（图3）。图3. SOUL研究：司美格鲁肽片显著降低MACE风险14%，且各组分呈一致性降低趋势该结果使得司美格鲁肽片成为目前首个且唯一经大规模优效性CVOT证实具有心血管获益的口服GLP-1RA。这也与注射剂型此前已确立的心血管获益证据形成闭环，进一步证实了司美格鲁肽分子在不同剂型间疗效的一致性。值得强调的是，SOUL研究人群在基线时已广泛接受包括他汀类药物、降压药、抗血小板药以及钠-葡萄糖共转运蛋白2抑制剂（SGLT2i，使用率26.9%）等药物在内的标准治疗，在此背景下仍能观察到显著MACE风险降低，提示司美格鲁肽片能够有效改善患者的心血管残余风险[21,22]。 — 相关阅读 — 心肾代谢管理的“灵魂革命”——SOUL研究完整数据全球首发倒计时 SOUL研究结果全面揭晓，口服司美格鲁肽片获得心血管保护优效性实证！ CV获益药物榜单再添新证：SOUL研究证实口服司美格鲁肽片的心血管保护作用三、深度探索：亚组分析揭示广泛人群获益与个体化线索随着SOUL研究主要结果的公布，2025年成为深度数据挖掘之年。在ACC、美国糖尿病协会（ADA）、欧洲心脏病学会（ESC）、欧洲糖尿病研究协会（EASD）等国际顶级学术会议上，一系列预设及事后亚组分析结果相继披露，进一步丰富了该研究的临床意义。亚洲人群获益尤为突出。SOUL研究数据显示，在占比23.4%的亚洲患者中，司美格鲁肽片的MACE风险降幅高达27%，显著优于整体人群的14%[23]。该发现与2025年发表于Diabetes Care的系统综述和荟萃分析结论一致，该分析指出GLP-1RA在亚洲人群中降低MACE风险的效果优于白种人[24]。联合治疗分析则解答了关键临床疑问。SOUL研究的预设分析证实，无论患者基线是否使用SGLT2i，司美格鲁肽片的MACE获益均保持一致（P交互作用=0.6561，图4），且与SGLT2i联合治疗的安全性良好[22]，这为两类指南推荐药物的联合应用提供了循证依据。图4. 根据基线使用SGLT2i与否分层的MACE发生率心衰与泛血管获益亦是亮点。在基线合并心衰患者中，司美格鲁肽片可显著降低由首次心衰住院、紧急心衰就诊或心血管死亡组成的复合终点风险达22%（P=0.02），且在射血分数保留的心衰及NYHA分级较低的患者中风险降低趋势更明显（图5）[25,26]。此外，该药还能使主要肢体不良事件风险总体降低29%[27]，且其MACE获益在不同血管病变范围患者中保持一致[28]。图5. 基线有心衰患者按心衰亚组和NYHA分级划分的复合心衰终点的森林图其他亚组分析还提示，司美格鲁肽片的MACE获益与基线HbA1c水平显著相关，在基线HbA1c>8%时更显著，且在不同BMI亚组中获益一致[29]。这些于2025年密集发布的数据，共同为司美格鲁肽片在广泛高危人群中具有一致且显著心血管保护作用提供了重要证据。 — 相关阅读 — “SOUL”深度对话：口服司美格鲁肽片确证心血管获益，将改变什么？亚洲人群MACE降幅27%只是开始？ADA SOUL专场，口服司美格鲁肽更多获益待揭晓 ADA 2025专场：深度解码SOUL研究，口服GLP-1RA心血管获益新洞见口服司美格鲁肽显著降低T2DM合并心衰患者复合心衰结局风险达22%，全面改善心血管危险因素 | ESC 2025 重磅！口服司美格鲁肽使肢体事件风险降低29%，住院风险全面降低 | EASD 2025 四、肾脏保护：真实世界研究提供降低蛋白尿的关键证据尽管司美格鲁肽片在SOUL研究中已显示出良好安全性，但其对肾脏结局，尤其是尿白蛋白肌酐比值（UACR）的影响，仍缺乏大规模真实世界证据支持。2025年，西班牙学者开展的一项全国性多中心回顾性研究Renal_ENDO2S-RWD为这一问题提供了关键且直接证据。该研究结果在EASD 2025年会上公布，并发表于Clinical Kidney Journal [30]。研究共纳入819例起始司美格鲁肽片治疗且具有基线及随访肾脏数据的T2DM患者。分析显示，在整体队列中，治疗6个月和12个月后UACR分别显著降低30.3%和40.0%。在基线UACR ≥30 mg/g患者中，UACR降幅更明显，分别达40.2%和50.7%；即使在基线UACR ≥300 mg/g患者中，UACR也呈显著下降。同时，无论患者基线蛋白尿严重程度或慢性肾脏病（CKD）分期如何，治疗期间估算肾小球滤过率（eGFR）均未发生具有临床意义的显著变化。此外，司美格鲁肽片在改善代谢指标、减轻体重、治疗安全性及用药持续性方面表现一致，不因CKD严重程度不同而存在组间差异。该研究首次以主要终点评估的方式，在真实临床实践中证实司美格鲁肽片具有明确的降低蛋白尿作用，从而为其肾脏保护效应增添了有力的真实世界佐证。 — 相关阅读 — 肾脏获益获力证！潘琦教授：真实世界研究显示口服司美格鲁肽显著降低蛋白尿超40% | EASD 2025 五、临床实践变革：GLP-1RA口服剂型破解应用瓶颈，推动CKM管理基于2025年全年积累的充分证据，口服GLP-1RA司美格鲁肽片展现出对T2DM管理的变革潜力。SOUL研究证实其口服剂型与注射剂型具有同等的心血管保护作用，从而解决了因注射给药方式导致的患者犹豫及医生面临的处方障碍。口服给药带来的便利性被普遍认为将显著提升治疗可及性与患者依从性。口服剂型的推出使心血管科、肾内科医生能够更顺畅地将具有明确心肾获益的GLP-1RA整合进入ASCVD或CKD患者的综合管理方案，这正符合当前心血管-肾脏-代谢（CKM）综合征共病共治的理念。有观点认为，GLP-1RA有望成为继经典“降压、调脂、抗凝”之后，心血管二级预防的“第四大基石”。这提示，司美格鲁肽片未来将从糖尿病治疗领域，更广泛融入CKM一体化管理。 — 相关阅读 — 从SOUL研究看司美格鲁肽的基石地位：口服GLP-1RA重塑CKM综合管理，升维心血管二级预防新支柱 | ADA 2025 六、结语纵观2025年，司美格鲁肽片凭借SOUL研究的里程碑式突破及一系列相关数据，实现了从传统降糖药物到改善CKM治疗药物的认知飞跃。随着中国人群疗效证据的不断夯实、心血管保护优效性的明确验证，以及在亚洲人群、心衰、泛血管疾病和肾脏保护等领域的深入探索，全年研究呈现出清晰而递进的证据链，充分展现了司美格鲁肽片在高危T2DM及CKM综合征管理中的治疗价值。尤为重要的是，口服剂型的临床优势在扎实证据支持下更加凸显，有望切实推动相关指南推荐的临床实践落地，从而让更便捷、更高效的治疗策略惠及更广泛患者，引领T2DM与CKM综合征管理进入新阶段。参考文献（上下滑动可查看） 1. Aroda VR, et al. Diabetes Care. 2019; 42(9): 1724-1732. PIONEER 1 2. Rodbard HW, et al. Diabetes Care. 2019; 42(12): 2272-2281. PIONEER 2 3. Rosenstock J, et al. JAMA. 2019; 321(15): 1466-1480. PIONEER 3 4. Pratley R, et al. Lancet. 2019; 394(10192): 39-50. PIONEER 4 5. Mosenzon O, et al. Lancet Diabetes Endocrinol. 2019; 7(7): 515-527. PIONEER 5 6. Husain M, et al. N Engl J Med. 2019; 381(9): 841-851. PIONEER 6 7. Pieber TR, et al. Lancet Diabetes Endocrinol. 2019; 7(7): 528-539. PIONEER 7 8. Zinman B, et al. Diabetes Care. 2019; 42(12): 2262-2271. PIONEER 8 9. Yamada Y, et al. Lancet Diabetes Endocrinol. 2020; 8(5): 377-391. PIONEER 9 10. Yabe D, et al. Lancet Diabetes Endocrinol. 2020; 8(5): 392-406. PIONEER 10 11. Wang W, et al. Diabetologia. 2024 Sep; 67(9): 1783-1799. PIONEER 11 12. Ji L, et al. Diabetologia. 2024 Sep; 67(9): 1800-1816. PIONEER 12 13. Jain AB, et al. Diabetes Obes Metab. 2024; 26(5): 1799-1807. PIONEER REAL Canada 14. Anastas Kick, et al. Diabetes Ther. 2024;15(3):623-637. PIONEER REAL Switzerland 15. van Houtum W, et al. Diabetes Ther. 2024; 15(8): 1749-1768. PIONEER REAL Netherlands 16. Catrina SB, et al. Diabetes Ther. Diabetes Ther. 2024; 15(9): 2079-2095. PIONEER REAL Sweden 17. Suzuki R, et al. J Diabetes Investig. 2024; 15(8): 1047-1056. PIONEER REAL Japan 18. Saravanan P, et al. Adv Ther. 2024; 41(11): 4266-4281. PIONEER REAL UK 19. Manti R, et al. Diabetes Ther. 2025; 16(5): 1019-1032. PIONEER REAL Italy 20. Delgado Álvarez E, et al. Diabetes Obes Metab. 2025; 27(9): 4812-4824. PIONEER REAL Spain 21. McGuire DK, et al. N Engl J Med. 2025; 392(20): 2001-2012. 22. Marx N, et al. Circulation. 2025; 151(23): 1639-1650. 23. McGuire DK, et al. N Engl J Med. 2025; 392(20): 2001-2012. Supplementary Appendix 24. Lee MMY, et al. Diabetes Care. 2025; 48(3): 489-493. 25. Pop-Busui R, et al. Effects of Oral Semaglutide on Heart Failure Outcomes in People With Type 2 Diabetes and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease: The SOUL Trial. Presented at ESC Congress 2025. 26. Pop-Busui R. SOUL: Heart Failure Outcomes. Presented at the 61st EASD Annual Meeting, 2025. 27. Cavender MA, et al. Effect of Oral Semaglutide on Major Adverse Limb Events Across the Spectrum of Vascular Disease in High-Risk Type 2 Diabetes: Insights From the SOUL Trial. Presented at the 61st EASD Annual Meeting, 2025. 28. Cavender M, et al. Effect of Oral Semaglutide on CV Outcomes Across the Vascular Disease Spectrum, From No Vascular Disease to Polyvascular Disease, in High-Risk Type 2 Diabetes. Presented at ESC Congress 2025. 29. Inzucchi SE, et al. Oral Semaglutide and Cardiovascular Outcomes by Baseline HbA1c and Body Mass Index in the SOUL Trial. Presented at the 61st EASD Annual Meeting, 2025. 30. Moreno-Pérez O, et al. Clin Kidney J. 2025; 18(8): sfaf227. 最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

2026-01-14

·Firstwordpharma

JPM26: Novo Nordisk, Eli Lilly trade blows on oral obesity aspirations

At the JP Morgan Healthcare Conference (JPM) on Tuesday, Eli Lilly and Novo Nordisk shared duelling visions for the launch of oral obesity medicines. The companies' CEOs also weathered — or smiled through — tonally contrasting Q&A sessions led by JPM analysts. Novo Nordisk's chief Mike Doustdar, five months into the job, was asked about a "difficult 2025 and commercial execution," while Lilly's Dave Ricks was congratulated on "obviously a very successful year for the company."The stakes are high in 2026 for Novo Nordisk to win back market share for its obesity business, and recent approval for oral Wegovy (semaglutide) is a prime opportunity to do so ahead of Eli Lilly's competing launch for small molecule GLP-1 agonist orforglipron. Analysts are expecting billions in revenue from each product, with the opportunity to unlock previously untapped portions of the obesity marketplace with an oral offering.With much on the line for Novo Nordisk, Doustdar came out swinging at JPM, speculating that dosing restrictions could be a factor on orforglipron's future label. "I have looked into [Eli Lilly's] clinical trial protocol [for orforglipron]…and if you're taking a specific type of statin, then you have to wait two to four hours to take it. Awful. I don't know about you, but I know how many obese patients take statins," Doustdar said.But Eli Lilly's Ricks pushed back during their own JPM time slot hours later. "There's been some questions on statin use with orforglipron coming out of the conference today…In our protocol — I think it's impressive that Novo's CEO reads our protocols — there was a prohibition on statin use and a few other drugs that have common drug-drug interactions," Ricks said to chuckles from the JPM audience. "That's just a timing thing. We had not completed the [drug-drug interaction] suite of studies. There's no reason scientifically to expect anything in our label or commercial after that." For Doudstar's next shot, he preemptively aimed at the fasting requirements around dosing for oral Wegovy, which are not expected to appear on orforglipron's label. "If I was sitting on the other side, I would try to drill on that one. That's the only thing I can think of that one can drill on," he commented. Doustdar referenced patient experience with Rybelsus, where "we have not seen this being an issue with 1.5 million people," adding that similar requirements are "not a problem" in other large disease settings like thyroid disease. Back in Eli Lilly's camp, where the pharma has successfully launched a direct-to-patient platform that reaches about a million US patients, it's now planning to replicate a similar cash-pay success with orforglipron in massive middle-income countries like India, Indonesia, China and Brazil it couldn't reach previously with Mounjaro/Zepbound (tirzepatide) due to refrigeration constraints. "Orforglipron plays an outsized role internationally," Ricks said of the pharma's plans for market dominance. The company is expecting a rollout in late '26 or early '27, which he hopes will address Lilly's major question of how deep the patient pool is in these international regions, particularly those willing to self-pay for an oral obesity drug. "There may be, I don't know, 100,000 people in a place like Brazil willing to do it. But are there 500,000? Are there 5 million? I think we have to find that out because there are no analogies," Ricks said. "As we go through 2026 and 2027 with orforglipron coming to market, that will help build confidence there… [and be] instructive as we sort of seek that out. Is the analogy other medicines? Certainly there's been much more limited uptake of self-pay medicines in these markets."While Doustdar similarly has pegged international markets as a large opportunity for Novo Nordisk's obesity products, he seemed more focused on Europe rather than the Asian and South American markets Lilly is gunning for."As attractive as a market [the US] is and will remain from a volume perspective, it will be the smaller player of the two sides of the Atlantic," he said. "The international operations of Novo Nordisk have always been one of its stronger footprints…And that's a competitive advantage because the market knows us." However, he added that Novo will face headwinds in its international operations in 2026 because semaglutide has lost exclusivity in a number of markets this year.And back on the home front in the US, Novo Nordisk is playing up both the efficacy of its oral offering, which comes with a package of cardiovascular benefit data, and the price point to get there — even if it some with "short term pain" for investors. "You have to stick with me during the bad period," Doustdar said.Elizabeth Eaton contributed to this report.

2025-11-26

·药明康德

司美格鲁肽再向FDA递交监管申请；一线治疗胃癌，FDA再批准阿斯利康单抗组合……

司美格鲁肽再向FDA递交监管申请诺和诺德（Novo Nordisk）今日宣布，已向美国FDA提交7.2 mg Wegovy（semaglutide，司美格鲁肽）注射剂的补充新药申请（sNDA），拟用于联合低热量饮食和增加体力活动，以帮助肥胖成人进行长期体重管理。7.2 mg Wegovy的监管申请也正在接受欧洲药品管理局（EMA）审评，预计2026年第一季度公布结果。本次申请主要基于来自STEP UP的研究结果，这是一项为期72周的3期、随机、双盲、安慰剂对照试验，入组1407名身体质量指数（BMI）≥30 kg/m²的肥胖成年人，患者均无糖尿病史。试验结果显示，在患者依从治疗的前提下，每周一次7.2 mg Wegovy使患者（基线平均体重249磅）在72周后实现了平均20.7%的体重下降，明显优于接受2.4 mg剂量患者的17.5%降幅及安慰剂组的2.4%。此外，33.2%的7.2 mg组患者体重降幅达到或超过25%，远高于2.4 mg组的16.7%与安慰剂组的0%。在将中途停药者纳入分析后，7.2 mg组患者的平均体重下降仍达18.7%，同样优于2.4 mg组的15.6%与安慰剂组的3.9%。此外，7.2 mg组中有90.7%的患者实现≥5%体重下降，亦高于2.4 mg组的89.9%和安慰剂组的36.8%。 Wegovy是一种GLP-1受体激动剂，它能够刺激胰岛素的生成，并抑制胰高血糖素分泌，降低食欲和食物摄入量。2021年6月FDA批准其用于治疗普通肥胖患者，它是自2014年以来美国FDA批准的首款用于控制普通肥胖症或超重的新药。该药物并在同年晚些时候再获欧盟批准治疗肥胖适应症。一线治疗胃癌，FDA再批准阿斯利康单抗组合美国FDA近日批准了阿斯利康（AstraZeneca）旗下Imfinzi（durvalumab）联合标准FLOT化疗（fluorouracil、leucovorin、oxaliplatin、docetaxel），用于可切除的胃癌或胃食管结合部腺癌（GC/GEJC）成人患者的术前及术后治疗，并在术后继续使用Imfinzi单药维持治疗。此次批准主要基于3期MATTERHORN研究的结果，该研究共纳入948名未经治疗、可切除的II期至IVA期GC/GEJC患者，按1：1随机接受Imfinzi联合FLOT或安慰剂联合FLOT的治疗方案。研究主要终点为盲法独立中心评估的无事件生存期（EFS），并评估了患者的总生存期（OS）及病理学完全缓解（pCR）。结果显示，Imfinzi联合FLOT组的中位EFS尚未达到（95% CI：40.7，不可估计[NE]），显著优于对照组的32.8个月（95% CI：27.9，NE），风险比为0.71（95% CI：0.58，0.86；p<0.001）。OS方面，两组中位OS均未达到，但Imfinzi联合组同样展现获益（HR=0.78；95% CI：0.63，0.96；p=0.021）。在病理学评估中，Imfinzi联合FLOT实现19.2%的pCR率，明显高于对照组的7.2%（p<0.001）。 Imfinzi是一种人源化的单克隆抗体。通过与PD-L1的结合，阻断PD-L1与PD-1和CD80蛋白的结合，进而抑制肿瘤的免疫逃逸机制。参考资料： [1] Novo Nordisk files for FDA approval of a higher dose of Wegovy® injection 7.2 mg. Retrieved November 26, 2025 from https://www.prnewswire.com/news-releases/novo-nordisk-files-for-fda-approval-of-a-higher-dose-of-wegovy-injection-7-2-mg-302626162.html [2] FDA approves durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma. Retrieved November 26, 2025 from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床3期临床结果加速审批临床成功临床2期

100 项与 Semaglutide(Vivani Medical) 相关的药物交易

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