This trial aims to improve the heart health of people with a narrowed aortic valve called aortic stenosis (AS) who then have aortic valve replacement (AVR) by assessing the change in the mass of the left ventricle.
Even after an AVR in many patients the heart is still unable to pump as well and can lead to heart failure.
This study will assess if medication used in other causes of heart failure can help participants having an AVR recover better. Researchers will compare two drugs, dapagliflozin and spironolactone, that have been shown to help patients with heart failure who do not have AS, to see if taking one or both medicines together will help patients with AS.
There will be four treatment arms: dapagliflozin, spironolactone, dapagliflozin and spironolactone together, and standard of care. These will be taken as one tablet of each IMP per day for 12 months.
Participants will have approximately four follow up visits, dependent on the treatment arm - those in an arm with spironolactone will have an extra safety follow up visit.
These medicines might help patients after AVR by reducing heart muscle thickness and scarring.

开始日期2026-12-01

申办/合作机构

University College London

NCT06560333

/ Withdrawn临床3期

Evaluate the Efficacy and Safety of the Combined Use of a Sodium-glucose Cotransporter 2 (iSGLT2) Inhibitor and a Dipeptidyl Peptidase-4 (iDPP -4) Inhibitor in the Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin

The present study aims to evaluate the efficacy and safety of different combinations of oral antidiabetics in patients with inadequate glycemic control on metformin monotherapy.

开始日期2026-11-30

申办/合作机构

Eurofarma Laboratórios SA

NCT07096986

/ Not yet recruiting临床2期IIT

Impact of Dapagliflozin for the Regulation of Immunological Activity in Membranous

WHY IS THIS RESEARCH BEING CONDUCTED? Membranous glomerulonephritis (MN) is an autoimmune disease that affects the kidneys through autoantibodies, meaning that antibodies produced by your body attack your own kidney cells. The appearance of these autoantibodies can be explained in part by a disruption in the immune response. Patients with this disease are treated with immunosuppressive drugs such as rituximab. The aim of this treatment is to reduce the production of all antibodies, including those responsible for the disease. Despite this treatment, some patients may experience a relapse of the disease. These relapses can be complicated by infections, blood clots in the blood vessels, and, in the long term, can lead to kidney failure and an increased cardiovascular risk. Relapses can also have an impact on patients' social and professional lives.
Dapagliflozin is a diuretic medication, which means that it is used to increase urine production and eliminate excess salt and water from the body to reduce edema (swelling). It is currently prescribed and authorized for patients with type 2 diabetes, heart failure and chronic kidney disease. This treatment has been shown to reduce the amount of proteins in the urine and protect the kidneys and cardiovascular system in patients with chronic kidney disease. A study has also shown that dapagliflozin may have an effect on the immune response.
WHAT DOES IT INVOLVE? The aim of our study will be to evaluate the efficacy of dapagliflozin in reducing disease autoantibodies and preventing relapses.
This research will be conducted at the Nice University Hospital and the Nîmes University Hospital. We expect to 20 patients to be recruited with an anti-PLA2R1 positive MN.
Participation in the study will last 6 months. The research is funded by Nice University Hospital. WHAT IS THE TREATMENT BEING STUDIED? It is dapagliflozin, a drug that is increasingly used routinely in patients with nephrotic syndrome (including MN) for its ability to reduce protein in the urine. Its effect on the immune system in MN has not yet been studied

开始日期2026-11-01

申办/合作机构

Centre Hospitalier Universitaire de Nice

100 项与达格列净相关的临床结果

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100 项与达格列净相关的转化医学

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100 项与达格列净相关的专利（医药）

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4,329

项与达格列净相关的文献（医药）

2027-02-01·TISSUE & CELL

Dapagliflozin uncouples the anti-inflammatory and lipogenic effects of pioglitazone in valproic acid-induced steatohepatitis in rats: Lipid-sensing nuclear receptors (LXRα and PPARγ) as the molecular nexus between hepatoprotection and lipogenesis

Article

作者: Hassan, Hend M ; Elshenawy, Dina S ; Elkatary, Rania G ; Saad, Somaya ; Hammad, Maha O

Valproic acid (VPA) is a foundation antiepileptic medication, implicated in dose-dependent hepatotoxicity via mitochondrial dysfunction, progression of oxidative-inflammatory cascade, and steatosis. LXRα/PPARγ are crucial regulators of hepatic lipogenesis, representing a pertinent therapeutic target. Dapagliflozin, a SGLT2 inhibitor and pioglitazone, a PPARγ agonist, are emerging therapies for metabolic hepatic steatosis; however, while pioglitazone confers notable anti-inflammatory benefits, its hepatic PPARγ signaling remains a recognized concern. The current study targets the individual or combined modulatory effects of both drugs on the hepatic LXRα and PPARγ pathways in VPA-induced steatohepatitis in rats. Forty male Sprague-Dawley rats were randomized into five groups: Control, VPA (500 mg/kg/d given orally), PIO + VPA (10 mg/kg/d pioglitazone), DAPA + VPA (1 mg/kg/d dapagliflozin), and COMB (1 mg/kg/d dapagliflozin and 10 mg/kg/d pioglitazone). All prophylactic treatments were orally given 1 h prior to VPA. Spectrophotometry, RT-PCR, histopathological and immunohistochemical parameters were used to assess hepatic injury across groups. The results indicated that hepatocytes are nudged toward increased lipogenesis in the VPA group via activation of hepatic PPARγ (P < 0.001), LXRα (P < 0.01), SREBP1c (P < 0.001), and perilipin 2 (P < 0.05). VPA was associated with impaired LFTs, dyslipidemia, altered MDA/GSH equilibrium, and intense NF-κB immunoreactivity (all P < 0.001), besides significant fibrosis (P < 0.001) and elevated histopathology scores (P < 0.01). Relative to VPA, PIO + VPA exhibited significant hepatic anti-inflammatory and antioxidative benefits, restoring LFTs (P < 0.001) and MDA/GSH equilibrium (P < 0.001), alongside inhibiting NF-κB immunoreactivity (P < 0.001), however; it failed to significantly improve histopathological scores or lipogenic effectors (P > 0.05). Relative to VPA, DAPA + VPA and COMB groups showed a downregulation of hepatic lipogenic effectors (PPARγ at P < 0.001, LXRα at P < 0.01, SREBP1c at P < 0.001, and perilipin 2 at P < 0.05), with additional improvement of histopathological scores (P < 0.05), fibrosis (P < 0.001), and lipid profiles (P < 0.001) while simultaneously restoring LFTs and hepatic redox status (P < 0.001). Within the scope of the available literature, this study is the first to elucidate the divergent effects of pioglitazone and dapagliflozin on VPA-induced steatosis through the intricate hepatic LXRα/PPARγ signaling, underscoring the pronounced hepatoprotective capacity of dapagliflozin, effectively rescuing pioglitazone's pro-steatotic signaling.

2026-12-31·RENAL FAILURE

Dapagliflozin improves hemoglobin and anemia in chronic kidney disease: a systematic review and meta-analysis

Review

作者: Irvania, Annida Naufal ; Yantisetiasti, Anglita ; Tsauri, Ghazwan Andes Ats ; Sofiatin, Yulia

Anemia becomes increasingly prevalent as kidney function declines. Current treatments carry multiple safety risks. Sodium-glucose cotransporter 2 inhibitors (SGLT2i), dapagliflozin, have emerged as background anemia modulator, a promising alternative, showing protective effects against anemia. This study synthesizes evidence on dapagliflozin's potential to improve anemia in chronic kidney disease (CKD) patients. A systematic review and meta-analysis was performed according to Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines, including eight studies identified from six databases. Risk of bias was assessed using tools appropriate for each study design (RoB 2, NOS, JBI). Data were pooled using a random-effects model with RevMan 5.4. The primary analysis for hemoglobin demonstrated significant increase (MD = 4.37; 95% CI = 0.71-8.03; p = 0.02) and remained significant in the sensitivity analysis (MD = 4.11; 95% CI = 0.19-8.04; p = 0.04). A sensitivity analysis for hematocrit revealed a highly significant increase (MD = 2.15; 95% CI = 1.86-2.44; p < 0.00001). In the sensitivity analysis for adverse events dapagliflozin significantly reduced the overall risk (RR = 0.77; 95% CI = 0.59-0.99; p = 0.04). This finding was associated with significantly lower mortality (RR = 0.67; p = 0.02), while no significant differences were observed for cardiovascular (p = 0.22) or genitourinary events (p = 0.70). Dapagliflozin is associated with clinically meaningful improvements in hemoglobin and anemia outcomes in CKD. These findings suggest a potential erythropoietic benefit beyond glycemic control, although dedicated anemia-focused trials are needed to confirm clinical applicability.

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Clinical events and healthcare costs of dapagliflozin in adults with cardiovascular-kidney-metabolic syndrome in Spain: a cost-offset analysis

Article

作者: Castro Gasch, Marta ; Rubio Ponce de León, Silvia ; Alcázar Arroyo, Roberto ; Comín-Colet, Josep ; Pomares, Elisenda ; Gutiérrez, Rodrigo ; Gómez, Gemma ; Espigares, Maria José ; Caudron, Christian ; Vallès Callol, Joan Antoni ; Navarro González, Juan Francisco ; Capel Sanchez, Margarita

AIMS:

Adults with cardiovascular-kidney-metabolic (CKM) syndrome, characterized by interactions among metabolic, chronic kidney disease (CKD) and cardiovascular disease, face a high symptomatic burden, mortality risk and costs. Dapagliflozin has demonstrated significant benefits in adults with type 2 diabetes (T2D), heart failure (HF) and CKD. This modelling study aimed to estimate the clinical events and associated healthcare costs of dapagliflozin in adults with CKM syndrome from the Spanish National Health System (NHS) perspective over 3 years.

METHODS AND RESULTS:

A cost-offset model compared clinical events and their associated costs of 100,000 adults with CKM syndrome treated with dapagliflozin added to standard of care (SoC) and SoC alone. Clinical event rates were derived from dapagliflozin trials (DECLARE-TIMI 58, DAPA-HF, DAPA-CKD and DELIVER), and costs from national databases and literature. Robustness was assessed through scenario and subgroup analyses. The carbon dioxide (CO₂) footprint impact associated with hospitalization for heart failure (HF), urgent HF visits and end-stage renal disease was assessed in an exploratory analysis. Over 3 years, dapagliflozin added to SoC prevented 10,151 clinical events (2,822 cardiovascular; 5,519 renal; 1,810 deaths) and saved €159.11 million per 100,000 adults compared to SoC, mainly by preventing end-stage renal disease (69%; -€110.32 million). Considering drug acquisition cost, the net cost saving was €52.47 million per 100,000 adults, representing a €1.49 return for every euro invested in dapagliflozin. Scenario analyses were consistent with the base case. Subgroup analyses showed greater benefits in adults with multiple comorbidities, especially those with all three conditions. The CO₂ footprint reduction was 2,176 tons of CO₂ per 100,000 adults.

CONCLUSION:

Dapagliflozin in adults with CKM syndrome reduced the incidence of clinical events, generating cost savings and improving the sustainability of the Spanish NHS.

2,718

项与达格列净相关的新闻（医药）

2026-09-07

·医脉通

ESC 2026 丨指南推荐和多维证据夯实心衰住院患者SGLT2i早期应用获益

心力衰竭（HF）是我国面临的重大公共卫生挑战，呈现高发病率、高患病率、高死亡率、高住院率及高经济负担的“五高”特征，患者预后较差，防控形势严峻1。钠-葡萄糖协同转运蛋白2抑制剂（SGLT2i）在心衰治疗中具有全射血分数谱获益证据，但既往研究多聚焦门诊心衰患者，针对住院心衰患者起始SGLT2i治疗的研究数据较少2。 2026年8月，发表在JACC Heart Fail上的一项Meta分析（DAPA-TRIO-HF研究）证实，达格列净可改善全射血分数心衰患者的心血管结局，无论是在住院场景还是门诊场景，起始达格列净治疗的获益是一致的2。同期，在欧洲心脏病学会年会（ESC 2026）上最新发布的《2026 ESC心力衰竭管理指南》着重强调了心衰患者住院期间病情稳定后早期启用SGLT2i的临床价值，并给予I级推荐3。大会公布的多项研究亦聚焦心衰患者住院期间早期启用SGLT2i，研究结果进一步夯实了SGLT2i在住院心衰患者治疗中的重要价值4-6。 DAPA-TRIO-HF研究：全射血分数谱心衰，住院与门诊启动达格列获益一致2 DAPA-TRIO-HF是目前针对单一SGLT2i、覆盖全射血分数范围、同时纳入门诊及住院心衰患者的最大规模荟萃分析，共纳入3项达格列净治疗心衰的随机对照研究：DAPA-HF（n=4744）、DELIVER（n=6263）、DAPA ACT HF-TIMI 68（n=2401）。主要终点为首次发生心血管死亡或首次心衰恶化事件发生的时间。依据入组时住院/门诊状态、年龄、性别、种族、2型糖尿病、估算肾小球滤过率（eGFR）、入组时左心室射血分数（LVEF）、基线堪萨斯城心肌病问卷总症状评分（KCCQ-TSS）、是否使用血管紧张素受体脑啡肽酶抑制剂（ARNI）、最近一次（含当前次）心衰住院时间分层，评估达格列净终点获益在各亚组间的一致性。 3项研究共纳入13408例受试者。研究结果显示，达格列净可降低心血管死亡或心衰恶化风险达22%（HR=0.78，95%CI：0.71~0.86，P<0.001），3项试验间治疗效应一致（I²=18.1%，P=0.36）（图1A）；其中，心血管死亡风险降低15%（HR=0.85，95% CI：0.75‑0.96；P=0.011），心衰恶化风险降低22%（HR=0.78，95% CI：0.69‑0.87；P＜0.001）。此外，达格列净可降低全因死亡风险13%（HR=0.87，95%CI：0.76-0.99，P=0.034）。图1 达格列净对HF患者心血管结局的综合治疗效果（A）主要和次要心血管结局；（B）亚组分析结果此外，达格列净治疗效果不受年龄、性别、种族、eGFR、是否合并糖尿病、基线LVEF、基线KCCQ-TSS、近期HF住院时间及是否使用ARNI影响，所有预设亚组中，达格列净降低心血管死亡或首次心衰恶化事件的获益是一致的（图1B）。并且无论是住院患者还是门诊患者，起始达格列净治疗的获益相当。 DAPA‑TRIO‑HF荟萃分析结果证实，达格列净可降低心衰患者的心血管死亡或心衰恶化风险约22%，同时显著降低其它多项致残、致死结局发生风险。结合既往研究的快速起效证据7，该研究支持在全射血分数谱心衰尽早使用达格列净。 ESC 2026最新研究：多维度证据加持，夯实住院心衰患者早期启用SGLT2i获益证据 ESC 2026上发布的多项研究从多维度验证了院内早期启动SGLT2i治疗的可行性与获益，为临床心衰早期规范化干预提供了更丰富的循证支撑。回顾性队列研究：住院期间早期启动SGLT2i对院内生存率和安全性的影响4 这项研究旨在比较在心衰住院患者中早期启动达格列净与恩格列净的疗效并评估其对院内生存率和安全性的影响，共纳入1546例于2023年7月至2025年4月期间因心衰住院的成人患者，分为达格列净组（n=450）、恩格列净组（n=398）或未早期启动SGLT2i组。早期启动SGLT2i定义为入院后48小时内开始治疗。主要终点为院内全因死亡率。总体而言，达格列净组与恩格列净组的院内生存率无显著差异（P=0.29，图2）。亚组分析显示，在HFrEF患者中，达格列净组生存率更高（76% vs 61%；P=0.001）；而在右心室功能障碍（36.8% vs 11.8%；P=0.02）和慢性肾脏病（33.3% vs 25%；P=0.032）患者中，恩格列净组生存率更高。在安全性方面，低血压较为罕见（恩格列净组0% vs 达格列净组0.5%；P<0.001），两组急性肾损伤发生率相似。图2 达格列净组与恩格列净组院内死亡率该研究表明，早期启动SGLT2i达格列净和恩格列净治疗具有相似的总体生存率和良好的安全性特征，支持在心衰患者住院期间早期使用SGLT2i。随机对照试验荟萃分析：心衰住院早期起始SGLT2i对心血管死亡率和首次再住院率的影响5 这项荟萃分析旨在评估住院心衰患者早期使用SGLT2i对心血管死亡和心衰再住院的影响。最终纳入3项试验（SOLOIST-WHF、DICTATE-AHF、EMPULSE）共1986例患者。主要复合终点为心血管死亡或首次心衰再住院。汇总分析结果显示，单独分析再住院或心衰恶化终点有降低的趋势，但未见统计学意义的降低。与之不同，心血管死亡或住院复合终点呈显著降低（RR 0.48，95% CI 0.23-0.99；P=0.05），但异质性较高（I²=95%）；心衰相关死亡或心血管死亡复合终点观察到一致的获益（RR 0.77，95% CI 0.60-1.00；P=0.05；I²=0%）。上述研究结果支持早期起始SGLT2i治疗在降低心血管死亡和死亡/住院复合终点风险方面的潜在临床价值。该研究表明，心衰住院期间病情稳定后起始SGLT2i可显著降低心血管死亡或首次心衰再住院风险。 iCaReMe全球注册研究揭示心衰患者基础治疗药物使用率的时间变化趋势6 2023年ESC心衰指南更新对全射血分数谱心衰人群使用SGLT2i给予I类推荐。本研究旨在了解指南发布前后心衰患者GDMT使用率和治疗模式的时间变化趋势。利用iCaReMe全球注册研究的心衰队列基线数据，覆盖亚太、拉丁美洲、中东和非洲地区的18个国家，根据2023 ESC心衰指南更新发布时间，将入组患者分为两组：第一阶段（2020年-2023年8月，n=2434）；第二阶段（2023年9月-2024年，n=713）。研究结果显示，与第一阶段相比，第二阶段患者GDMT使用率提高：SGLT2i（56.2% vs 51.0%；P=0.0135）和盐皮质激素受体拮抗剂（MRA）（56.5% vs 51.2%；P=0.0129）使用率升高，其中HFpEF患者的SGLT2i使用率升高尤为显著（49.7% vs 34.8%；P<0.0001）。HFrEF四联疗法（肾素-血管紧张素系统[RAS]阻滞剂+β受体阻滞剂+MRA+SGLT2i）呈升高趋势，从37.9%升至43.3%（P=0.0574）（图4）。图4 指南发布前后临床特征及治疗策略变化该分析显示，2023 ESC指南更新后，GDMT使用率取得了可喜的提升，尤其是SGLT2i和MRA，包括SGLT2i在HFpEF患者中的应用。然而，即使在HFrEF患者中，四联疗法使用率仍低于50%，临床实践仍然存在较大缺口。本研究结果提示，需持续开展继续教育、优化诊疗流程，缩小临床实践与循证指南之间的差距。结语本届ESC 2026年会发布的多项重要研究与最新循证数据，为心衰住院患者早期应用SGLT2i治疗提供了多维度丰富的循证证据。DAPA-TRIO-HF荟萃分析证实，达格列净可为全射血分数谱心衰患者带来一致的心血管获益，住院早期启动治疗与门诊场景的获益相当。多项ESC最新公布的研究进一步验证了心衰住院患者早期启用SGLT2i的临床价值。此外，真实世界注册研究显示，随着心衰指南的更新，SGLT2i等GDMT的临床使用率逐步提升，但心衰规范化药物治疗落地仍存在明显缺口。随着循证证据不断夯实，临床实践更加重视住院心衰患者尽早启动SGLT2i治疗，以实现心衰全病程规范化管理。正确答案：ABCD 点击显示答案「参考文献」 1.中国疾病预防控制中心, 中国老年医学学会心电与心功能分会. 中国心力衰竭防治进展报告（白皮书）. 中国循环杂志,2026,41(4):318-342. 2.Berg DD, Vaduganathan M, Docherty KF, Bellavia A, Murphy SA, Claggett BL, Desai AS, Inzucchi SE, Patel SM, Wiviott SD, Solomon SD, McMurray JJV, Sabatine MS. Dapagliflozin in Patients With Heart Failure Across the Care Spectrum: A Meta-Analysis of DAPA-HF, DELIVER, and DAPA ACT HF-TIMI 68. JACC Heart Fail. 2026 Aug;14(8):103232. 3.Køber L, Adamo M, Ruwald AC, Tomasoni D, Anderson LJ, Andersson C, Brugts JJ, Chioncel O, Donal E, Ferdinandy P, Jhund PS, Leyva F, Lorusso R, Madigan M, Mullens W, Paolillo S, Ryan N, Simpson M, Thiele H, Thune JJ, Van Craenenbroeck EM, Van Laake LW, Verbakel M; ESC Guidelines Advisory Group. 2026 ESC Guidelines for the management of heart failure. Eur Heart J. 2026 Aug 28:ehag100. 4.Nada Benameur，et al. Early in-hospital initiation of dapagliflozin versus empagliflozin in acute heart failure: impact on in-hospital survival and safety. ESC 2026. 5.N Shafi,et al. Does initiating SGLT2 inhibitors at an early stage of heart failure admission really reduce cardiovascular mortality and first rehospitalization? A meta-analysis of randomized controlled trials. ESC 2026 6.K. Khunti, et al. Temporal trends in guideline-directed medical therapy adoption in heart failure: insights from the iCaReMe global registry. ESC 2026 7.Berg DD, Jhund PS, Docherty KF, et al. Time to clinical benefit of dapagliflozin and significance of prior heart failure hospitalization in patients with heart failure with reduced ejection fraction. JAMA Cardiol. 2021;6:499– 507 审批编号：CN-193877 有效期至：2026-12-04 本材料由阿斯利康提供，仅供医疗卫生专业人士参考，不用于推广目的。若涉及具体药物使用，请参考相关药物说明书，阿斯利康不建议您将产品超说明书使用。撰写：Yuki 审校：Hong 排版：Atai 执行：Atai 本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。

临床结果临床3期临床2期

2026-09-07

·恒瑞医药

2026 EASD前瞻｜恒瑞医药口服小分子GLP-1RA、胰岛素周制剂、GLP-1/GIP双受体激动剂、GLP-1/GIP/GCG三受体激动剂等多项重磅研究入选LBA

第62届欧洲糖尿病研究协会（EASD）年会将于2026年9月28日至10月2日在意大利米兰举行。本次大会，恒瑞医药多项重磅研究入选LBA（最新突破摘要），包括：口服小分子GLP-1RA HRS-7535两项2型糖尿病Ⅲ期研究数据、基础胰岛素周制剂SHR-3167两项2型糖尿病Ⅱ期研究数据、GLP-1/GIP双受体激动剂瑞普泊肽注射液（研发代号HRS9531；大中华区外称KAI-9531，由Kailera Therapeutics开发）用于肥胖合并多内分泌代谢卵巢综合征（PMOS）的Ⅱ期研究数据、GLP-1/GIP/GCG三受体激动剂HRS-4729一项Ⅰ期研究数据1。此外，Kailera Therapeutics的一项瑞普泊肽注射液Ⅰ期研究数据也将在本次大会上由Kailera公布1。口服小分子GLP-1RA HRS-7535 中稿类型：Short Oral Discussions 摘要号：LBA 39 英文标题：Oral small-molecule GLP-1RA HRS-7535 as monotherapy in Chinese adults with early type 2 diabetes: the OUTSTAND-1 Phase 3 trial. 中文标题：口服小分子GLP-1受体激动剂HRS-7535单药治疗中国成人早期2型糖尿病：OUTSTAND-1 Ⅲ期临床试验。讲者：于淼，北京协和医院时间：9月29日12:00-13:00 CEST 中稿类型：Orals 摘要号：LBA 10 英文标题：Oral HRS-7535 versus dapagliflozin in Chinese adults with type 2 diabetes inadequately controlled with metformin: the OUTSTAND-2 Phase 3 trial. 中文标题：口服HRS-7535与达格列净在二甲双胍控制不佳的中国成人2型糖尿病患者中的比较：OUTSTAND-2 Ⅲ期临床试验。讲者：郭立新，北京医院时间：9月29日15:30-15:45 CEST 胰岛素周制剂SHR-3167 中稿类型：Short Oral Discussions 摘要号：LBA 97 英文标题：Once-weekly insulin SHR-3167 versus once-daily insulin glargine U100 in type 2 diabetes without previous insulin treatment. 中文标题：每周一次胰岛素SHR-3167与每日一次甘精胰岛素U100在未接受过胰岛素治疗的2型糖尿病患者中的比较。讲者：曾梅芳，恒瑞医药时间：10月1日12:45-13:45 CEST 中稿类型：Short Oral Discussions 摘要号：LBA 96 英文标题：Efficacy and safety of once-weekly insulin SHR-3167 vs daily insulin degludec in type 2 diabetes participants previously treated with basal insulin with or without oral antidiabetic drugs. 中文标题：每周一次胰岛素SHR-3167与每日一次德谷胰岛素在既往接受基础胰岛素（联合或不联合口服降糖药）治疗的2型糖尿病患者中的疗效与安全性。讲者：赵琳，复旦大学附属中山医院时间：10月1日12:45-13:45 CEST GLP-1/GIP双受体激动剂瑞普泊肽注射液中稿类型：Short Oral Discussions 摘要号：LBA 74 英文标题：Efficacy and safety of ribupatide (HRS9531) in participants with obesity and polyendocrine metabolic ovarian syndrome (PMOS): a multicentre, randomised, double-blind, Phase 2 trial. 中文标题：瑞普泊肽（HRS9531）在肥胖合并多内分泌代谢卵巢综合征（PMOS）患者中的疗效与安全性：一项多中心、随机、双盲、Ⅱ期临床试验。讲者：姜宏卫，河南科技大学第一附属医院时间：10月1日12:45-13:45 CEST 中稿类型：Short Oral Discussions 摘要号：756 英文标题：Effect of injection site on the relative bioavailability and safety of ribupatide, a novel dual GLP-1/GIP receptor agonist: Phase 1, randomised, single-dose crossover study results. 中文标题：注射部位对新型GLP-1/GIP双受体激动剂瑞普泊肽相对生物利用度和安全性的影响：一项I期、随机、单剂量交叉研究结果。讲者：Marianne Camargo, Kailera Therapeutics 时间：10月1日12:45-13:45 CEST GLP-1/GIP/GCG三受体激动剂HRS-4729 中稿类型：Short Oral Discussions 摘要号：LBA 41 英文标题：Safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS-4729, a novel GLP-1/GIP/glucagon triple-receptor agonist: a randomised, double-blind, placebo-controlled Phase 1 study. 中文标题：新型GLP-1/GIP/胰高血糖素三受体激动剂HRS-4729的安全性、耐受性、药代动力学和药效学：一项随机、双盲、安慰剂对照的I期研究。讲者：贺坤，山东第一医科大学附属中心医院时间：9月29日12:00-13:00 CEST 本次大会恒瑞医药GLP-1类产品及胰岛素周制剂多项重磅临床数据集中亮相，充分彰显了中国在代谢病创新药研发领域的学术实力与临床研究能力。恒瑞医药将持续聚焦2026 EASD最新研究进展，为大家带来更多恒瑞重磅研究数据分享，敬请关注。参考来源：1.https://www.easd.org/annual-meeting/easd-2026/programme/ 声明： 1.本新闻旨在分享学术前沿动态，仅供医疗卫生专业人士基于学术目的参阅，非广告用途。 2.恒瑞医药不推荐任何未被批准的药品、适应症的使用。撰稿：非肿瘤医学事务部心血管代谢团队排版：程梦真责编：李玉莹往期精选 | 研发创新 | 中国首个自主研发长效胰岛素类似物！恒瑞医药创新药瑞恒盈®获批上市 | 国际化 | 恒瑞医药与百时美施贵宝达成战略合作协议，携手推进肿瘤学、血液学及免疫学创新疗法创新药出海再下一城！恒瑞医药HER2 ADC瑞康曲妥珠单抗实现海外独家许可 | 重磅奖项 | 再传捷报！恒瑞医药创新药氟唑帕利胶囊（艾瑞颐®）专利荣获中国专利金奖捷报！恒瑞医药创新药海曲泊帕乙醇胺片（恒曲®）专利荣获中国专利金奖 | 社会公益 | 恒瑞医药捐赠1000万港元，驰援香港大埔火灾救助 “健康中国行·重走长征路”项目启动仪式圆满举行！恒瑞提供公益支持，助力健康中国

临床2期临床3期临床结果

2026-09-07

·今日头条

华东医药发威，1类新药引燃2200亿市场

根据药物临床试验登记与信息公示平台（CTR）最新消息，华东医药的1类新药HDM1005注射液启动第4项Ⅲ期临床试验，拟用于阻塞性睡眠呼吸暂停（OSA）合并肥胖或超重。米内网数据显示，2025年中国三大终端六大市场消化系统及代谢药（化+生）销售额超2200亿元，2026Q1继续保持增长。来源：CTR官网 HDM1005注射液为华东医药子公司中美华东制药研发的1类创新药，属于GLP-1R/GIPR双靶点长效多肽类激动剂，可同时激活GLP-1受体和GIP受体，进一步增强胰岛素分泌，改善脂肪代谢。从CTR官网获悉，华东医药已于近日启动了HDM1005注射液的第4项Ⅲ期临床试验（登记号：CTR20263391），拟用于阻塞性睡眠呼吸暂停（OSA）合并肥胖或超重。在此之前，该药拟用于超重或肥胖、2型糖尿病等三项Ⅲ期临床试验已先后于2025年9月、2026年2月启动。 HDM1005注射液此前在国内启动的Ⅲ期临床试验来源：米内网中国临床试验数据库在中国三大终端六大市场（统计范围详见本文末），消化系统及代谢药（化+生）近两年销售额重现攀升，2025年再度突破2200亿元；2026Q1同比增长4.39%，从渠道格局上看，公立医院终端以超六成的份额领跑市场。近年来中国三大终端六大市场消化系统及代谢药（化+生）销售趋势（单位：万元）来源：米内网格局数据库 2026Q1中国三大终端六大市场消化系统及代谢药（化+生）二级集团格局中，诺和诺德稳守第一，销售额超50亿元；华东医药排名第三，销售额接近15亿元。产品格局方面，达格列净片、司美格鲁肽注射液高居前二，替尔泊肽注射液销售额暴涨2272.89%。 2026Q1中国三大终端六大市场消化系统及代谢药（化+生）二级集团TOP10 来源：米内网格局数据库注：增长率不足4%用*表示在消化系统及代谢药领域，华东医药已有8款1类新药处于获批临床及以上阶段，包括4款化药和4款生物药；按治疗亚类统计，糖尿病用药、其它消化道和代谢用药、减肥药各占6个、1个和1个席位。华东医药消化系统及代谢药1类新药研发情况来源：米内网综合数据库从最高研发进度看，除HDM1005注射液外，DR10624注射液、HDM1002片均已步入Ⅲ期临床；其中前者为全球首创（FIC）长效三靶点激动剂，拟用于高甘油三酯血症；后者为全球首款进入临床阶段的口服小分子GLP-1受体激动剂，拟用于糖尿病、超重或肥胖。此外，注射用重组酰化胰高血糖素样肽2类似物正处于Ⅱ期临床阶段，拟用于短肠综合征、化疗相关性腹泻。资料来源：米内网数据库、CTR官网注：米内网《中国三大终端六大市场药品竞争格局》，统计范围：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至9月4日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。

临床3期生物类似药临床1期申请上市临床2期

100 项与达格列净相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09763	达格列净	A10BK01	DB06292

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
1型糖尿病	日本	阿斯利康制药有限公司	2019-03-26
慢性心力衰竭	欧盟	AstraZeneca AB	2012-11-11
慢性心力衰竭	冰岛	AstraZeneca AB	2012-11-11
慢性心力衰竭	列支敦士登	AstraZeneca AB	2012-11-11
慢性心力衰竭	挪威	AstraZeneca AB	2012-11-11
慢性肾病	澳大利亚	AstraZeneca Pty Ltd.	2012-10-22
2型糖尿病	澳大利亚	AstraZeneca Pty Ltd.	2012-10-22
心脏衰竭	澳大利亚	AstraZeneca Pty Ltd.	2012-10-22

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
急性心肌梗塞	临床3期	瑞典	AstraZeneca PLC	2020-12-22
急性心肌梗塞	临床3期	英国	AstraZeneca PLC	2020-12-22
急性Q波心肌梗死	临床3期	瑞典	AstraZeneca PLC	2020-12-22
急性Q波心肌梗死	临床3期	英国	AstraZeneca PLC	2020-12-22
急性失代偿性心力衰竭	临床3期	美国	AstraZeneca PLC	2020-04-01
阵发性呼吸困难	临床3期	美国	AstraZeneca PLC	2020-04-01
射血分数降低的心力衰竭	临床3期	美国	AstraZeneca PLC	2019-04-09
射血分数降低的心力衰竭	临床3期	日本	AstraZeneca PLC	2019-04-09
射血分数降低的心力衰竭	临床3期	巴西	AstraZeneca PLC	2019-04-09
射血分数降低的心力衰竭	临床3期	加拿大	AstraZeneca PLC	2019-04-09

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04717986 (Pubmed \| Curr Probl Cardiol)	临床3期	-	181	Dapagliflozin 10 mg	廠築獵網選鑰廠簾鏇憲(襯繭廠窪鹹遞廠構艱衊) = 製獵齋鹹顧襯鏇醖廠製觸網餘餘顧積觸壓齋衊 (鏇壓構衊觸簾淵艱蓋繭 ) 更多	积极	2026-10-01
				Placebo	觸廠鹽製餘襯淵壓糧夢(衊淵顧網衊窪餘餘簾鹽) = 積憲廠鹹選願簾選廠醖觸網築衊築遞衊鹹餘鏇 (淵艱願齋衊選範醖築鑰 )
NCT04743453 (Pubmed \| Transplantation)	临床3期	功能障碍	208	Dapagliflozin 10 mg/d	廠窪鹹獵範襯鏇壓膚窪(選窪觸鏇鏇製鏇壓選獵) = 獵遞遞築夢願鬱觸壓衊鑰餘選窪築艱膚觸築顧 (艱廠鬱顧餘鏇憲夢膚艱 ) 更多	不佳	2026-07-01
				PLACEBO	鹹餘範觸淵簾顧衊襯餘(襯選齋衊築壓糧膚齋夢) = 鑰鑰構遞遞膚願淵鹽膚遞觸範醖夢網壓憲窪觸 (壓鑰糧衊積夢顧構選製, 1.2) 更多
BENEFACTOR (ADA2026)	N/A	2型糖尿病	3,770	Dapagliflozin+Glimepiride+Metformin Fixed-Dose Combinations (FDC)	鹽壓齋製顧衊觸鏇醖鬱(餘製齋餘觸憲鬱簾製觸) = 壓鬱觸範觸積餘簾鹽艱窪築築築獵築艱製築壓 (壓衊鬱願網衊簾蓋壓鬱 ) 更多	积极	2026-06-20
ADA2026	N/A	2型糖尿病	1,612,340	Dapagliflozin (Type 2 Diabetes)	鏇繭鬱淵餘憲壓醖窪襯(餘壓夢窪鏇繭鹽蓋壓膚): HR = 0.99 (95.0% CI, 0.97 ~ 1.0) 更多	积极	2026-06-20
				Empagliflozin (Type 2 Diabetes)
ADA2026	N/A	代谢功能障碍相关的脂肪肝病	54	Saroglitazar 4 mg	選齋願糧築鑰鹹窪淵襯(積廠鑰製顧鹽憲齋觸繭): P-Value = 0.04 更多	积极	2026-06-20
				Dapagliflozin 10 mg
NCT04363697 (DAPA ACT HF-TIMI 68, CTgov)	临床4期	心肌梗塞 \| 心脏衰竭	2,401	Dapagliflozin (Dapagliflozin)	壓積餘廠願窪鹹鏇鬱網 = 壓願糧膚襯餘築鬱繭構觸遞鏇選願餘夢齋壓蓋 (觸繭醖願簾範膚願網範, 繭齋糧夢淵窪製製齋構 ~ 醖遞繭壓醖膚願範蓋襯) 更多	-	2026-06-16
				Placebo (Placebo)	壓積餘廠願窪鹹鏇鬱網 = 憲鏇襯觸範憲艱獵鹽鹹觸遞鏇選願餘夢齋壓蓋 (觸繭醖願簾範膚願網範, 繭繭淵繭壓衊積餘鬱製 ~ 築簾構獵顧獵鬱醖餘壓) 更多
EULAR2026	N/A	痛风	57	Dapagliflozin 10 mg + Febuxostat 20 mg	淵醖獵鏇衊鹽齋鑰築鬱(鏇觸觸鏇構糧鑰繭繭襯) = 繭鑰鏇壓簾製鹽製齋鑰觸鑰獵齋鏇蓋獵齋鬱鹹 (選鏇襯壓夢積鑰獵鹽顧 ) 更多	积极	2026-06-11
				Febuxostat 20mg	淵醖獵鏇衊鹽齋鑰築鬱(鏇觸觸鏇構糧鑰繭繭襯) = 構襯顧艱襯壓簾願鏇醖觸鑰獵齋鏇蓋獵齋鬱鹹 (選鏇襯壓夢積鑰獵鹽顧 )
NCT04965935 (INFINITI2019, CTgov)	临床3期	2型糖尿病 \| 肾移植排斥反应	52	Dapagliflozin 10 MG Oral Tablet (Dapagliflozin Tablets)	築蓋蓋廠選衊衊鬱醖膚(選鬱鹹淵糧襯廠構遞夢) = 膚選襯鏇廠醖遞願鏇窪廠襯蓋積選製蓋選壓顧 (窪鏇積廠夢製餘襯遞夢, 2.084) 更多	-	2026-06-08
				Placebo Matching Dapagliflozin Oral Tablet (Placebo Matching Dapagliflozin Tablets)	築蓋蓋廠選衊衊鬱醖膚(選鬱鹹淵糧襯廠構遞夢) = 廠襯積膚繭齋餘鹽觸簾廠襯蓋積選製蓋選壓顧 (窪鏇積廠夢製餘襯遞夢, 2.12) 更多
NCT05788276 (DEAK, Pubmed \| BMJ Open)	临床2期	-	150	Dapagliflozin	顧壓衊壓構遞積憲蓋製(願廠衊醖築夢廠積齋簾) = 網艱鹹顧獵蓋簾襯艱獵顧糧積鬱鏇襯鏇鬱壓淵 (淵築顧襯繭選築廠齋鹽 ) 更多	积极	2026-06-01
				Placebo	衊糧顧築糧簾製範蓋範(觸衊衊鏇觸衊獵膚餘鏇) = 鬱蓋鹽蓋獵醖構觸獵獵餘艱願鏇顧醖餘觸壓鏇 (夢網鹽膚鹹鏇鑰鑰鬱選, 26.0) 更多
NCT06263673 (Pubmed \| Front Neurol)	临床2期	路易体病 \| 帕金森病	12	Sitagliptin 100 mg	艱範鑰鹹鬱壓願鏇廠鬱(顧衊願壓蓋鹹顧獵鹹製): P-Value = 0.008 更多	积极	2026-05-29
				Dapagliflozin 10 mg