An Active-comparator-controlled, Open-label, Parallel Group Study to Evaluate the Effect of Survodutide on Energy Expenditure and Fatty Acid Oxidation in Subjects With Obesity

This study is open to adults between 18 and 65 years of age who have obesity. People can join the study if they have a body mass index (BMI) between 30 and 45 km/m². The purpose of this study is to find out whether a medicine called survodutide improves how the body uses energy and breaks down fat. This study compares survodutide with another medicine called semaglutide. Survodutide is being developed to treat people with obesity.
Semaglutide is already used to treat people with obesity.
Participants are put into 2 groups by chance. One group gets survodutide and the other group gets semaglutide. Participants get survodutide or semaglutide as an injection under the skin once a week. Participants are in the study for about 8 months. During this time, they visit the study site weekly. Some of the visits may also be done at the participant's home instead of the study site.
At some of the visits, doctors test how much energy a participant's body uses. This is done in a special room where they measure the oxygen that is breathed in and the carbon dioxide that is breathed out by the participant. The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

开始日期2025-02-28

申办/合作机构

Boehringer Ingelheim GmbH

NCT06772532

/ Not yet recruiting临床1期

Relative Bioavailability of Three Different BI 456906 Formulations Following Subcutaneous Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Three-period, Three-sequence Crossover Trial)

The main objective of this trial is to investigate relative bioavailability of BI 456906 formulation B and BI 456906 formulation C vs. BI 456906 formulation A.

开始日期2025-02-03

申办/合作机构

Boehringer Ingelheim GmbH

NCT06632457

/ Recruiting临床3期

A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis

This study is open to adults who are at least 18 years old and have:
* A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or
* A confirmed liver disease called metabolic-associated steatohepatitis (MASH)
* BMI of 27 kg/m2 or more or
* 25 kg/m2 or more if the participant is Asian.
People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.
Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.
The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.

开始日期2024-11-12

申办/合作机构

Boehringer Ingelheim GmbH

100 项与 Survodutide 相关的临床结果

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100 项与 Survodutide 相关的转化医学

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100 项与 Survodutide 相关的专利（医药）

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项与 Survodutide 相关的文献（医药）

2025-02-01·DIABETES OBESITY & METABOLISM

Survodutide, a glucagon receptor/glucagon‐like peptide‐1 receptor dual agonist, improves blood pressure in adults with obesity: A post hoc analysis from a randomized, placebo‐controlled, dose‐finding, phase 2 trial

Letter

作者: Hussain, Samina Ajaz ; Lucas, Kathryn J. ; le Roux, Carel W. ; Steen, Oren ; Unseld, Anna ; Startseva, Elena ; Ekinci, Elif I. ; Hennige, Anita M.

2025-01-01·PHARMACOLOGICAL REVIEWS

Emerging pharmacotherapies for obesity: A systematic review

Article

作者: Al Rifai, Jana ; Valenzuela-Vallejo, Laura ; Rhayem, Caline ; Kokkorakis, Michail ; Mantzoros, Christos S ; Mantzoros, Christos S. ; Chakhtoura, Marlene ; Ghezzawi, Malak

The history of anti-obesity pharmacotherapies is marked by disappointments, often entangled with societal pressure promoting weight loss and the conviction that excess body weight signifies a lack of willpower. However, categories of emerging pharmacotherapies generate hope to reduce obesity rates. This systematic review of phase 2 and phase 3 trials in adults with overweight/obesity investigates the effect of novel weight loss pharmacotherapies, compared to placebo/control or Food and Drug Administration-approved weight loss medication, through searching Medline, Embase, and ClinicalTrials.gov (2012-2024). We identified 53 phase 3 and phase 2 trials, with 36 emerging anti-obesity drugs or combinations thereof and four withdrawn or terminated trials. Oral semaglutide 50 mg is the only medication that has completed a phase 3 trial. There are 14 ongoing phase 3 trials on glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) (ecnoglutide, orforglipron, TG103), GLP-1 RA/amylin agonist (CagriSema), GLP-1/glucagon RAs (mazdutide, survodutide), GLP-1/glucose-dependent insulinotropic polypeptide and glucagon RA (retatrutide), dapagliflozin, and the combination sibutramine/topiramate. Completed phase 2 trials on incretin-based therapies showed a mean percent weight loss of 7.4-24.2%. Almost half of the drugs undergoing phase 2 trials were incretin analogs. The obesity drug pipeline is expanding rapidly, with the most promising results reported with incretin analogs. Data on mortality and obesity-related complications, such as cardio-renal-metabolic events, are needed. Moreover, long-term follow-up data on the safety and efficacy of weight maintenance with novel obesity pharmacotherapies, along with studies focused on under-represented populations, cost-effectiveness assessments, and drug availability, are needed to bridge the care gap for patients with obesity. Significance Statement Obesity is the epidemic of the 21st century. Except for the newer injectable medications, drugs with suboptimal efficacy have been available in the clinician's armamentarium. However, emerging alternatives of novel agents and combinations populate the obesity therapeutic pipeline. This systematic review identifies the state and mechanism of action of emerging pharmacotherapies undergoing or having completed phase 2 and phase 3 clinical trials. The information provided herein furthers the understanding of obesity management, implying direct clinical implications and stimulating research initiatives.

2025-01-01·EUROPEAN JOURNAL OF CLINICAL INVESTIGATION

Glucagon and glucagon‐like peptide‐1 dual agonist therapy: A possible future towards fatty kidney disease

Review

作者: Zoccali, Carmine ; Ozbek, Lasin ; Kanbay, Mehmet ; Copur, Sidar ; Guldan, Mustafa ; Mallamaci, Francesca

Abstract:

Background:

Obesity is a growing epidemic affecting approximately 40% of the adult population in developed countries with major health consequences and comorbidities, including diabetes mellitus and insulin resistance, metabolically associated fatty liver disease, atherosclerotic cardiovascular and cerebrovascular diseases and chronic kidney disease. Pharmacotherapies targeting significant weight reduction may have beneficial effects on such comorbidities, though such therapeutic options are highly limited. In this narrative review, we aim to evaluate current knowledge regarding dual agonist therapies and potential implications for managing fatty kidney and chronic kidney disease.

Results and Conclusion:

Glucagon‐like peptide‐1 agonists and sodium‐glucose cotransporter‐2 inhibitors are two novel classes of glucose‐lowering medications with potential implications and beneficiary effects on renal outcomes, including estimated glomerular filtration rate, albuminuria and chronic kidney disease progression. Recently, dual agonist therapies targeting glucagon‐like peptide‐1 and glucagon receptors, namely survodutide and cotadutide, have been evaluated in managing metabolically associated fatty liver disease, a well‐established example of visceral obesity. Fatty kidney is another novel concept implicated in the pathophysiology of chronic kidney disease among patients with visceral obesity.

212

项与 Survodutide 相关的新闻（医药）

2025-02-12

·智药邦

Nat Rev Drug Discov｜2025年药物开发和使用展望

2025年1月15日，来自IQVIA的研究人员在Nature Reviews Drug Discovery上发表文章Outlook for medicines development and use in 2025，分析了2025年药物创新、AI应用、投资并购等多领域的变革。 2025年将成为医疗保健和生命科学行业的变革之年。在药物创新领域，肿瘤学、免疫学和罕见病药物的主导地位正受到新型肥胖症药物快速扩张的挑战，这些新药可广泛改善心血管和代谢风险因素。尽管投资和并购的资金前景看好，但医疗系统的能力不足正阻碍创新药物的应用，并推动许多系统进入改革阶段。在药物研发和医疗服务领域，人工智能（AI）的应用正日益普及并释放潜力，2025年其相关法规也将落地。这些变化发生在一个愈发不稳定的环境中。地缘政治摩擦威胁着生命科学全球化的趋势，行业需要在不确定性中确保持续进步。以下我们重点展望未来一年的关键进展领域。肿瘤学创新肿瘤学仍将是治疗创新的前沿。今年，美国FDA可能批准首款个性化癌症疫苗--Moderna的mRNA-4157联合默克的PD1靶向单抗帕博利珠单抗（Keytruda）用于黑色素瘤，这一疗法可能改变癌症治疗格局。双特异性抗体的最新数据令人瞩目：在非小细胞肺癌领域，同时靶向PD1和VEGF的ivonescimab成为首个在三期试验中疗效超越帕博利珠单抗的药物。尽管该数据仅来自中国试验，但ivonescimab的全球研究仍在推进，新标准疗法或即将诞生。此外，首个靶向同一靶点（HER2）两个表位的双抗zanidatamab于2024年11月获FDA批准用于胆道癌，预计今年将惠及患者。给药方式的创新也在持续。2024年9月，FDA批准了罗氏PDL1抑制剂阿替利珠单抗（Tecentriq）的皮下注射剂型；同年12月，百时美施贵宝的PD1抑制剂纳武利尤单抗（Opdivo）皮下制剂也获批。随着帕博利珠单抗在2024年三期试验中取得成功，其皮下剂型或很快上市。肥胖症药物 2024年，基于GLP-1的疗法Wegovy（司美格鲁肽，诺和诺德）和同时靶向GIP受体的Mounjaro/Zepbound（替尔泊肽，礼来）推动全球肥胖症处方药市场突破300亿美元。尽管2025年预计无新药上市，但已上市及在研药物的关键试验结果将陆续公布，包括替尔泊肽在2型糖尿病患者中的心血管结局数据（来自SURPASS-CVOT试验），以及口服司美格鲁肽在早期阿尔茨海默病患者中的认知和功能影响数据（EVOKE和EVOKE+试验）。三期数据方面，礼来的orforglipron可能成为首个口服GLP-1受体激动剂，勃林格殷格翰的survodutide（靶向胰高血糖素和GLP-1受体）或成为诺和诺德/礼来双头垄断的首个潜在竞争者。诺和诺德的CagriSema（同时靶向胰淀素和降钙素受体）与替尔泊肽的头对头试验结果也备受关注。支付方对肥胖症药物覆盖范围的决策将成为市场长期发展的关键指标。全球最大的公共肥胖症药物覆盖计划是美国针对65岁及以上人群的Medicare，当前仅覆盖肥胖合并心血管风险人群的Wegovy。但新一届美国政府可能反对扩大此类药物覆盖，倾向非药物干预。在欧洲，英国国民医疗服务体系（NHS）将大规模推广Mounjaro，首批覆盖BMI≥35且至少有一种合并症的患者，预计未来三年治疗至少22万人。配套开展的五年真实世界试验SURMOUNT-REAL计划2025年启动，反映支付方对肥胖症药物成本效益证据的迫切需求。2025年还将涌现更多真实世界证据，包括患者依从性数据。投资与并购展望 2023年生物制药并购活动从疫情低谷反弹后，2024年再度降温，交易总额450亿美元，同比下降62%。尽管2024年缺乏并购催化剂，但支撑交易的动力在2025年依然强劲。需求端，大型药企营收超过1.5万亿美元，且到2030年将有超过2000亿美元的收入面临专利悬崖风险，部分巨头当前销售额的64%可能受损。投资者对肥胖症、抗体药物偶联物（ADC）和双特异性抗体等增长领域的压力也在增加。供给端，生物技术公司承担约70%临床阶段管线研发，其中60%资产尚未合作，包括近期试验数据亮眼的肥胖症候选药，如Viking的双GLP-1/GIP受体激动剂VK2735和Structure Therapeutics的口服GLP-1受体激动剂GSBR-1290。尽管IPO市场重启且利率下降提振生物科技股，但三分之二上市生物技术公司仍资金不足，现金储备恐不足12个月。 2025年并购短期前景仍然需保持谨慎，交易方需消化美国大选结果及宏观环境、地缘政治和监管趋势（包括《通胀削减法案》潜在修订）。但随着不确定性消退，预计并购活动将回暖，大型药企面临填补收入缺口和缩小增长差距的压力，加之美国联邦贸易委员会（FTC）干预减少，可能推动交易升温。 AI应用分化 AI工具的能力与应用将继续快速增长。然而，患者层面结局预测的复杂性叠加欧洲新法规，预计将导致AI在临床前药物开发中的广泛应用与临床场景中的渐进式推广出现分化。欧盟《人工智能法案》部分条款将于2025年2月2日生效，对全球AI监管产生影响。对药物开发而言，该法案将约束临床场景中的AI应用--包括诊断、监测、辅助治疗决策或与患者互动。另一监管巨头美国预计不会超越现有其或欧盟的做法。除监管外，算法效率、硬件性能和训练数据可用性的稳步提升，将推动AI计算性能在未来一年至少翻倍，增强其生物学和医学预测能力。但生物系统高度复杂，从分子水平预测迈向细胞或人体水平仍面临挑战。因此，预计更多AI发现分子将进入临床试验，但AI在临床证据生成中的应用步伐较慢。消费者化趋势加剧心血管代谢疾病等高发慢性病的“消费者化”趋势日益显著，表现为患者自费私人和处方药需求上升、私营处方平台增长，以及临床级诊断和监测技术向消费者端渗透（如智能手表的心电监测功能）。这一趋势在扩大市场的同时，也引发医疗公平的伦理争议。多重因素驱动该趋势：慢性病（如肥胖症）等慢性病的影响越来越大，医疗保健系统面临着巨大的双重预算挑战，同时也伴随着新疗法的成本。部分原因在于，这些系统限制了覆盖范围，进一步助长了自费支付和和患者自主决策。商业因素亦加速分化：创新疗法收回研发成本的时间窗口缩短，对真实世界证据的需求增加，使得持续患者参与以创造需求和确保可及性更为关键。结语 2025年，药物开发和生命科学行业的基础将面临变革：AI与财务能力的增强将与地缘政治摩擦加剧形成制衡，美国政府的更迭将影响全球最大医药研发基地和市场，并产生波及药物开发的全球地缘政治效应。在此背景下，药物创新进展将主要集中于未满足需求领域，肥胖症、肿瘤学、疼痛和罕见病领域的试验数据和审批决定最受关注。与其他生态系统类似，医疗系统的变革将遭遇阻力与反馈循环--具体表现为医疗系统能力限制、监管政策和新私营市场的相互作用。参考资料： https://doi.org/10.1038/d41573-025-00012-2 --------- End --------- 感兴趣的读者，可以添加小邦微信加入读者实名讨论微信群。添加时请主动注明姓名-企业-职位/岗位或姓名-学校-职务/研究方向。

信使RNA临床3期疫苗并购

2025-02-01

·抗体圈

“万能药” GLP-1：除了减肥，还有这 7 大功效！

你或许听说过 GLP-1，它最近在减肥领域可是相当火爆，不少人靠它成功减重。但你知道吗？GLP-1 就像个 “万能药”，本事可不止这一点！它还有许多让人惊喜的作用，今天就来给大家好好讲讲。 GLP-1 受体激动剂能降低血糖，还能减慢食物在胃肠道的消化速度，从而让人食欲下降。凭借这些效果，它获得了美国食品药品监督管理局（FDA）的批准，用于治疗 2 型糖尿病和肥胖症。市场研究机构对它的前景十分看好，Coherent Market Insights 预测，到 2031 年，GLP-1 市场规模将接近 560 亿美元；Global Data 更是预测，到 2033 年这一数字会飙升至 1110 亿美元，几乎翻了一倍！最近这几个月，越来越多的研究发现，GLP-1 在治疗其他疾病方面也潜力巨大。虽然目前大多还处于初步研究阶段，但已经为拓展新的应用方向打下了基础，也让它的市场潜力进一步增加。接下来，就给大家详细介绍 BioSpace 研究发现的 GLP-1 的 7 个新 “本领”。1. 治疗阻塞性睡眠呼吸暂停阻塞性睡眠呼吸暂停（OSA）可不是个小问题，全球有超过 10 亿人受它困扰，而且很多人都没意识到自己患病，也没有接受治疗。肥胖和超重是引发 OSA 的重要原因，因为多余的脂肪会在睡觉时压迫气管。礼来公司就利用了这一关联，成功将自家的重磅减肥药物 tirzepatide（Zepbound）的应用范围扩展到了 OSA 的治疗上。2024 年 12 月 20 日，FDA 批准 tirzepatide 用于治疗中度至重度阻塞性睡眠呼吸暂停合并肥胖症的成年人。这可是针对这两种疾病的首款处方药，不过使用时还得配合低热量饮食和适当增加运动。 tirzepatide 获批靠的是 SURMOUNT-OSA 试验（NCT05412004）的数据支撑。在试验中，它表现相当出色，达到了所有主要和关键次要终点。和安慰剂组相比，用药组患者的呼吸暂停低通气指数（AHI）平均降低了 62.8%。在关键次要终点方面，接受最高剂量 tirzepatide 治疗的患者里，有 47% 达到了疾病缓解标准。2. 改善慢性肾脏病据美国国家肾脏基金会的数据，糖尿病是导致肾功能衰竭的首要因素，新发病例中有 40% 以上都和它有关。诺和诺德（NovoNordisk）公司看准这点，把用于治疗 2 型糖尿病的 semaglutide（商品名 Ozempic）和用于慢性体重管理的 Wegovy，尝试用于治疗 2 型糖尿病患者的慢性肾脏病。目前，FDA 正在审查诺和诺德新增适应症的申请，预计 2025 年 1 月给出结果。2024 年 12 月，欧洲药品管理局已经允许在 Ozempic 的说明书里增加降低肾脏疾病相关风险的内容。在 III 期 FLOW 试验中，诺和诺德证实，使用 semaglutide 的 2 型糖尿病患者，出现肾功能发作、肾功能下降以及肾脏相关或心血管死亡的概率降低了 24%，全因死亡率也降低了 20%。另外，礼来公司也没闲着，正在研发下一代肥胖候选药物 retatrutide，希望能改善肥胖患者的心血管和肾脏状况。这款药可不简单，除了作用于 GLP-1，还能靶向并激活 GIP 和胰高血糖素受体。3. 助力代谢功能障碍相关脂肪性肝炎（MASH）治疗最近的研究发现，GLP-1 受体激动剂对肝脏健康似乎很有帮助。多家药企都在这方面发力，进行相关药物的研发。 2024 年 6 月，礼来公布了 II 期 SYNERGY-NASH 研究的详细结果。研究表明，tirzepatide 可能改善 MASH 患者的肝纤维化状况，也就是减轻肝脏的瘢痕形成。经过 52 周的治疗，高达 73% 接受 tirzepatide 治疗的患者，MASH 症状消失了，而且纤维化没有恶化；还有高达 59% 的参与者，纤维化至少改善了一个阶段，同时 MASH 也没有加重。诺和诺德在 2024 年 11 月公布了 MASH 中 III 期 ESSENCE 研究的详细结果。试验显示，在 72 周的随访中，近 63% 接受 semaglutide 治疗的患者，肝炎症状消退且纤维化没有恶化；37% 的患者纤维化有所改善，脂肪性肝炎也没有加重；近 33% 的患者更是实现了脂肪性肝炎消退和纤维化改善的双重效果。除了这两家，勃林格殷格翰也在开发用于 MASH 治疗的胰高血糖素 / GLP-1 受体双重激动剂 survodutide。2024 年 2 月公布的 II 期研究数据显示，48 周时，83% 的患者经活检证实 MASH 得到改善，纤维化没有恶化，而安慰剂对照组只有 18.2%。10 月，这家药企启动了 survodutide 的两项 III 期 MASH 试验。韩美制药也不甘示弱，正在推进三重激动剂 efocipegtrutide 的开发。它能同时靶向并激活 GLP-1、GIP 和胰高血糖素受体，和其他单靶点药物相比，对 MASH 和纤维化的治疗效果可能更好。目前，这款候选药物处于 IIb 期开发阶段。4. 对抗阿尔茨海默病、帕金森病阿尔茨海默症协会指出，35 - 65 岁的人如果肥胖，患痴呆症的风险会增加 30%。2024 年 1 月发表在《转化医学杂志》上的一项研究发现，礼来的 tirzepatide 能激活参与神经元生长的信号通路，还能保护神经元免受高血糖和胰岛素抵抗造成的损伤。 2024 年 7 月，一项 IIb 期研究发现，诺和诺德的 GLP-1 药物利拉鲁肽（商品名 Saxenda，用于治疗 2 型糖尿病），能减缓轻度阿尔茨海默病患者的认知能力下降。不过，虽然在一年的随访中，用药患者比安慰剂对照组恶化速度慢了 18%，但该试验评估利拉鲁肽对认知影响的把握度还不够。目前，诺和诺德正在开展 III 期 EVOKE 和 EVOKEPlus 试验，在早期阿尔茨海默病患者中测试 semaglutide 的效果，这两项研究预计 2025 年 9 月完成主要阶段。丹麦的 Kariya Pharmaceuticals 公司也在利用 GLP-1 治疗神经退行性疾病，他们研发的 KP405 是 GLP-1 和 GIP 受体的首创双重激动剂，正在进行 I 期临床测试，希望能用来减缓帕金森病的发展进程。5. 治疗 1 型糖尿病 1 型糖尿病是一种自身免疫性疾病，患者的免疫细胞会攻击胰腺中的胰岛细胞，导致胰岛素分泌出现问题。 GLP-1 能根据血糖水平诱导胰岛素分泌，所以对 1 型糖尿病可能也有效果。2024 年 10 月发表在《美国医学会杂志》上的一项研究显示，从 2010 年到 2023 年，接受 GLP-1 受体激动剂治疗的 1 型糖尿病患者比例从 0.3% 上升到了 6.6%。这说明，即便还没得到 FDA 批准，医生和处方者已经看到了这类药物在 1 型糖尿病治疗上的潜力。还有不少数据能证明这一点。比如 2022 年的一项回顾性研究发现，在现实生活中，1 型糖尿病患者使用 GLP-1 受体激动剂一年后，胰岛素的使用剂量明显减少。2019 年的一项研究也认为，GLP-1 疗法可以成为 1 型糖尿病患者重要的辅助治疗选择。6. 降低 10 种肥胖相关癌症风险凯斯西储大学医学院和俄亥俄州 MetroHealth System 的研究人员关注到 13 种肥胖相关癌症（OAC），这些癌症和体内过多的脂肪组织有关，肥胖会让患病风险增加，预后也更差。研究人员分析了美国 1.13 亿患者的电子健康记录，其中超过 160 万 2 型糖尿病患者分别接受了 GLP-1 受体激动剂、胰岛素或二甲双胍治疗。结果发现，GLP-1 受体激动剂能显著降低多种 OAC 的发病风险。具体来说，接受 GLP-1 治疗的患者，患胆囊癌和脑膜瘤的可能性比使用胰岛素的患者分别低 65% 和 63%；患胰腺癌的风险降低了 59%，患肝细胞癌的风险降低了 53%，患卵巢癌的风险降低了 48%。总的来看，GLP-1 受体激动剂与 13 种 OAC 中的 10 种癌症风险降低都有关系。7. 对抗成瘾有希望 GLP-1 受体激动剂还有个让人意想不到的作用 —— 可能对抗成瘾性疾病。 2024 年 7 月，一项模拟试验分析了近 22.3 万名患者的电子健康记录数据，发现和胰岛素相比，索马鲁肽能让烟草成瘾风险降低 32%。 2024 年 9 月，一项回顾性队列研究发现，诺和诺德的 GLP-1 类似物 semaglutide 和阿片类药物过量风险降低有关。和胰岛素、二甲双胍相比，semaglutide 分别让阿片类药物过量风险降低了 58% 和 54%。和噻唑烷二酮类药物、DPP-4 抑制剂相比，优势更明显，能让阿片类药物过量风险分别降低 68% 和 63%。据 Endpoints News 报道，礼来虽然还没正式宣布相关试验，但表示明年会针对肥胖药物用于酒精和药物滥用治疗开展大规模研究。美国国家酒精滥用和酒精中毒研究所也在和北卡罗来纳大学教堂山分校合作，进行 II 期试验，测试 semaglutide 对酒精滥用患者的疗效。宾夕法尼亚州立大学则在对诺和诺德的 Victoza（利拉鲁肽）进行研究，用于治疗阿片类药物使用障碍患者。 GLP-1 的这些新发现太令人惊喜了！不过目前很多研究还在进行中，未来它还会给我们带来哪些惊喜呢？让我们拭目以待！参考资料：https://www.biospace.com/drug-development/7-indications-for-glp-1s-beyond-weight-loss 识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床结果

2025-01-30

·PRNewswire

Metabolic Dysfunction-Associated Steatohepatitis Market to Register Stunning Growth at a CAGR of 17.9% in the US by 2034 | DelveInsight

The MASH treatment landscape is evolving rapidly, driven by a diverse array of therapeutic classes, each with unique mechanisms and potential impacts. The forecast period reveals significant shifts and emerging trends that will shape future market dynamics. LAS VEGAS, Jan. 30, 2025 /PRNewswire/ -- DelveInsight's Metabolic Dysfunction-Associated Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, MASH emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Metabolic Dysfunction-Associated Steatohepatitis Market Report According to DelveInsight's analysis, the market size for MASH was found to be USD 2.1 billion in the 7MM in 2023. In 2023, there were an estimated 42 million prevalent cases of MASH in the 7MM. Out of these, a total of ~15 million cases were diagnosed, and this number is projected to increase by the end of 2034 in the 7MM. Leading MASH companies such as Inventiva Pharma, Novo Nordisk A/S, Cirius Therapeutics, Akero Therapeutics, 89bio, Boehringer Ingelheim, Zealand Pharma, Galectin Therapeutics, Lipocine, Viking Therapeutics, Eli Lilly and Company, Boston Pharmaceuticals, Pfizer, HighTide Biopharma, CytoDyn, Merck & Co., Hanmi Pharmaceutical, Hepagene (Shanghai), Hepion Pharmaceuticals, Enyo Pharmaceuticals, Gilead Sciences, Poxel SA, Zydus Therapeutics, Sagimet Biosciences, Ionis Pharmaceuticals, Corcept Therapeutics, and others are developing novel MASH drugs that can be available in the MASH market in the coming years. The promising MASH therapies in the pipeline include Lanifibranor (IVA337), Semaglutide, Azemiglitazone (MSDC-0602K), Efruxifermin (EFX), BIO89-100 (Pegozafermin), Survodutide (BI 456906), GR-MD-02 (Belapectin), LPCN1144, VK2809, Tirzepatide, BOS-580, Ervogastat (PF-06865571) + Clesacostat (PF-05221304), HTD1801, Leronlimab (PRO 140), Efinopegdutide, HPG1860, Rencofilstat (CRV431), EYP001 (Vonafexor), Semaglutide/Cilofexor/Firsocostat, PXL065, Saroglitazar Magnesium, Denifanstat (TVB-2640), ION224, Miricorilant (CORT118335), and others. In March 2024, Madrigal Pharmaceuticals' groundbreaking product, REZDIFFRA (resmetirom), a once-daily, oral THR-ß agonist, received accelerated endorsement from the US FDA based on results from the Phase III MAESTRO-NASH trial. This approval marks a significant stride in the medical landscape, as REZDIFFRA becomes the inaugural and sole FDA-sanctioned therapy for adults afflicted with non-cirrhotic MASH, accompanied by moderate to advanced liver scarring (fibrosis) corresponding to stages F2–F3 fibrosis. Discover which therapies are expected to grab the major MASH market share @ Metabolic Dysfunction-Associated Steatohepatitis Market Report Metabolic Dysfunction-Associated Steatohepatitis Overview Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease that stems from metabolic dysfunction, often linked to obesity, diabetes, and other conditions of metabolic syndrome. MASH is characterized by the accumulation of fat in liver cells, accompanied by inflammation and liver cell injury, which can progress to fibrosis, cirrhosis, or even liver cancer. The primary drivers of MASH include insulin resistance, obesity, type 2 diabetes, and dyslipidemia. Genetic predisposition and a sedentary lifestyle also play significant roles. Environmental factors, such as a poor diet high in sugars and fats, exacerbate the condition. MASH is often asymptomatic in its early stages. When symptoms occur, they can include fatigue, vague abdominal discomfort, or pain in the upper right quadrant. In advanced stages, signs of liver dysfunction such as jaundice, swelling of the abdomen or legs, and confusion may arise. Diagnosis involves a combination of clinical history, physical examination, and diagnostic tests. Blood tests measuring liver enzymes (ALT, AST) often indicate liver inflammation. Imaging techniques like ultrasound, MRI, or FibroScan can identify liver fat and fibrosis. In some cases, a liver biopsy is required to confirm the diagnosis and assess disease severity. Metabolic Dysfunction-Associated Steatohepatitis Epidemiology Segmentation The MASH epidemiology section provides insights into the historical and current MASH patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The MASH market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Prevalent Cases of MASH Diagnosed Prevalent Cases of MASH Gender-specific Diagnosed Prevalent Cases of MASH Severity-specific Diagnosed Prevalent Cases of MASH Metabolic Dysfunction-Associated Steatohepatitis Treatment Market The approval of REZDIFFRA (resmetirom) in March 2024 represents a pivotal achievement in medical innovation, transforming the treatment landscape for MASH disease. This groundbreaking therapy addresses the root causes of MASH, offering renewed hope to patients grappling with this challenging condition. Clinical trials have shown impressive results, with REZDIFFRA effectively reducing symptoms like inflammation and fibrosis, enhancing liver function, and improving patients' quality of life. By providing healthcare professionals with a robust treatment option, this approval addresses a critical unmet need and has the potential to significantly alleviate the complications linked to advanced liver disease. The prevalence of MASLD is strongly linked to type 2 diabetes mellitus and obesity, particularly in individuals with a higher body mass index. However, MASLD occurrence is reduced in T2DM patients receiving treatments such as sodium-glucose cotransporter-2 (SGLT2) inhibitors, GLP-1 receptor agonists, and insulin. Vitamin E, with its antioxidant properties, is regarded as a first-line pharmacological option for managing MASH, especially when dietary and lifestyle interventions are insufficient. Antifibrotic agents can help prevent the progression of liver fibrosis and MASLD into fibrotic MASH. The role of pioglitazone, an anti-diabetic medication, in improving MASH histology in T2DM patients is well-documented, but concerns remain regarding potential side effects like weight gain, fluid retention, cancer risk, and bone fractures. Additional therapeutic targets for MASLD and MASH include G protein-coupled receptors (GPCRs), estrogen-related receptor alpha (ERRα), bone morphogenetic proteins (BMPs), and KLFs. Bariatric surgery, or weight loss surgery, is the most effective intervention for treating obesity and diabetes, as it reduces food absorption while influencing gut hormone secretion and metabolic function. To know more about MASH treatment guidelines, visit @ Metabolic Dysfunction-Associated Steatohepatitis Management Metabolic Dysfunction-Associated Steatohepatitis Pipeline Therapies and Key Companies Lanifibranor (IVA337): Inventiva Pharma Semaglutide: Novo Nordisk A/S Azemiglitazone (MSDC-0602K): Cirius Therapeutics Efruxifermin (EFX): Akero Therapeutics BIO89-100 (Pegozafermin): 89bio Survodutide (BI 456906): Boehringer Ingelheim/Zealand Pharma GR-MD-02 (Belapectin): Galectin Therapeutics LPCN1144: Lipocine VK2809: Viking Therapeutics Tirzepatide: Eli Lilly and Company BOS-580: Boston Pharmaceuticals Ervogastat (PF-06865571) + Clesacostat (PF-05221304): Pfizer HTD1801: HighTide Biopharma Leronlimab (PRO 140): CytoDyn Efinopegdutide: Merck & Co./Hanmi Pharmaceutical HPG1860: Hepagene (Shanghai) Rencofilstat (CRV431): Hepion Pharmaceuticals EYP001 (Vonafexor): Enyo Pharmaceuticals Semaglutide/ Cilofexor/ Firsocostat: Gilead Sciences PXL065: Poxel SA Saroglitazar Magnesium: Zydus Therapeutics Denifanstat (TVB-2640): Sagimet Biosciences ION224: Ionis Pharmaceuticals Miricorilant (CORT118335): Corcept Therapeutics Discover more about MASH drugs in development @ Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics The MASH market dynamics are expected to change in the coming years. Growing research activities and multiple clinical trials for MASH, driven by the rapid surge in its prevalence due to rising obesity and type 2 diabetes rates, highlight an active drug development pipeline and an expanding market size. The large pool of patients and lucrative growth opportunities present attractive prospects for key players, further supported by ongoing preclinical studies aimed at advancing imaging techniques for MASH diagnosis, potentially eliminating the need for invasive biopsy-based histopathological confirmation. Furthermore, potential therapies are being investigated for the treatment of MASH, and it is safe to predict that the treatment space will significantly impact the MASH market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the MASH market in the 7MM. However, several factors may impede the growth of the MASH market. Lack of awareness and negligence in the early stages of MASH by physicians often lead to disease progression, culminating in irreversible damage where liver transplantation becomes the only viable option. Diagnosing advanced MASH typically requires procedures like liver biopsy, which are costly, invasive, and risky. Regulatory challenges also pose hurdles, as the FDA mandates achieving one MASH endpoint for approval, while the EMA's draft guidance requires efficacy in both endpoints, potentially delaying first-mover approvals in major European markets. Additionally, access to expensive MASH treatments may be limited in certain regions, further hindering patient adoption. Moreover, MASH treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, MASH market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact MASH market growth. Scope of the Metabolic Dysfunction-Associated Steatohepatitis Market Report Therapeutic Assessment: Metabolic Dysfunction-Associated Steatohepatitis current marketed and emerging therapies Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics: Key Market Forecast Assumptions of Emerging Metabolic Dysfunction-Associated Steatohepatitis Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Metabolic Dysfunction-Associated Steatohepatitis Market Access and Reimbursement Download the report to understand which factors are driving MASH market trends @ Metabolic Dysfunction-Associated Steatohepatitis Market Trends Table of Contents Related Reports Non-Alcoholic Steatohepatitis Epidemiology Forecast Non-Alcoholic Steatohepatitis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted NASH epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan. Nonalcoholic Steatohepatitis Pipeline Nonalcoholic Steatohepatitis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nonalcoholic steatohepatitis companies, including Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Inventiva, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, 89bio, Inc., Eccogene, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Arrowhead Pharma, LG Chem, Redx Pharma, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Aligos Therapeutics, Altimmune, Inc., Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, among others. Non-Alcoholic Fatty Liver Disease Market Non-Alcoholic Fatty Liver Disease Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key NAFLD companies, including MediciNova, Eli Lilly and Company, AstraZeneca, Inventiva Pharma, Oasis Pharmaceuticals, LLC, Madrigal Pharmaceuticals, Inc., BioMarin Pharmaceutical, GlaxoSmithKline, Zydus Therapeutics Inc., Akero Therapeutics, Inc, Pfizer, Boehringer Ingelheim, Neuraly, Inc., Merck Sharp & Dohme LLC, Rivus Pharmaceuticals, Inc., Hepion Pharmaceuticals, Inc. , among others. 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临床3期

100 项与 Survodutide 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
隐源性肝硬化	临床3期	美国	勃林格殷格翰（中国）投资有限公司	2024-11-12
隐源性肝硬化	临床3期	中国	勃林格殷格翰（中国）投资有限公司	2024-11-12
隐源性肝硬化	临床3期	日本	勃林格殷格翰（中国）投资有限公司	2024-11-12
隐源性肝硬化	临床3期	阿根廷	勃林格殷格翰（中国）投资有限公司	2024-11-12
隐源性肝硬化	临床3期	澳大利亚	勃林格殷格翰（中国）投资有限公司	2024-11-12
隐源性肝硬化	临床3期	奥地利	勃林格殷格翰（中国）投资有限公司	2024-11-12
隐源性肝硬化	临床3期	比利时	勃林格殷格翰（中国）投资有限公司	2024-11-12
隐源性肝硬化	临床3期	巴西	勃林格殷格翰（中国）投资有限公司	2024-11-12
隐源性肝硬化	临床3期	保加利亚	勃林格殷格翰（中国）投资有限公司	2024-11-12
隐源性肝硬化	临床3期	加拿大	勃林格殷格翰（中国）投资有限公司	2024-11-12

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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


NCT04771273 (1404-0043, CTgov)	临床2期	非酒精性脂肪性肝炎 \| 纤维化	295	Survodutide (Survodutide 2.4 mg - Planned Maintenance Treatment)	鏇糧鬱廠遞繭範繭夢膚(壓醖餘衊願醖蓋構齋廠) = 網獵製範鹽獵積鏇選構獵襯繭憲餘遞糧膚艱糧 (獵壓襯窪製衊鬱繭齋鏇, 網憲廠繭築餘鏇積蓋糧 ~ 壓鏇觸鏇網鬱窪淵艱鏇) 更多	-	2024-12-03
				Survodutide (Survodutide 4.8 mg - Planned Maintenance Treatment)	鏇糧鬱廠遞繭範繭夢膚(壓醖餘衊願醖蓋構齋廠) = 願獵選蓋餘齋衊積衊鹹獵襯繭憲餘遞糧膚艱糧 (獵壓襯窪製衊鬱繭齋鏇, 鏇淵廠築範鏇廠範艱鏇 ~ 膚蓋憲範選窪壓膚醖壓) 更多
ESC2024	临床2期	肥胖	387	Survodutide 4.8 mg	夢願餘築網廠廠鏇顧觸(製鹽膚範膚夢糧膚鬱夢) = 遞糧鏇鹽構繭築膚廠製觸積鑰壓簾憲鑰製網網 (齋糧蓋製網艱遞鏇齋顧 )	积极	2024-09-01
NCT04153929 \| NCT04667377 \| NCT03591718 (1665-P, ADA2024)	临床1/2期	2型糖尿病 \| 肥胖 HbA1c \| insulin sensitivity \| glucose biomarkers ... 更多	-	Survodutide	願糧襯鹽衊簾艱觸築觸(艱網衊願繭衊鹽膚繭遞) = 0.4 vs 0.0 鬱繭壓鹽簾鹽夢齋觸糧 (襯膚憲糧繭範網觸獵窪 ) 更多	积极	2024-06-14
				Placebo
ADA2024	N/A	肥胖	-	Survodutide 20 nmol/kg	鬱淵廠積願淵衊鹽壓築(夢積淵醖簾餘壓膚鏇壓) = 75% reduction 製醖齋鑰鏇糧窪膚襯鑰 (積鹹鹽願網憲鹽餘夢衊 ) 更多	-	2024-06-14
NCT04771273 (1404-0043, Pubmed)	临床2期	非酒精性脂肪性肝炎	293	Survodutide 2.4 mg	築選簾簾餘網鬱築齋獵(繭壓餘網顧醖築獵憲獵) = 糧壓艱範齋鬱鏇願襯構蓋構夢築願鹽繭膚繭餘 (範範壓網鏇築鏇繭顧遞 ) 更多	积极	2024-06-07
				Survodutide 4.8 mg	築選簾簾餘網鬱築齋獵(繭壓餘網顧醖築獵憲獵) = 膚積積鏇構築衊憲壓鏇蓋構夢築願鹽繭膚繭餘 (範範壓網鏇築鏇繭顧遞 ) 更多
ENDO2024	N/A	-	-	Semaglutide 15 nmol/kg	襯願繭繭觸積繭網糧夢(觸夢獵廠簾顧鏇鹹簾網) = 願鬱鑰鏇壓淵廠膚糧積衊壓襯選艱簾鏇築膚鹹 (淵積蓋築簾觸憲窪範衊 )	-	2024-06-01
				Survodutide 15 nmol/kg	襯願繭繭觸積繭網糧夢(觸夢獵廠簾顧鏇鹹簾網) = 壓窪積膚願衊壓鏇獵遞衊壓襯選艱簾鏇築膚鹹 (淵積蓋築簾觸憲窪範衊 )
NCT04667377 (Phase II Trial, ENDO2024)	临床2期	-	384	Survodutide 4.8 mg	糧淵簾襯獵簾餘積廠醖(選衊膚鏇築鏇製觸蓋壓) = 齋鑰構窪願醖壓積築鏇顧糧衊憲窪餘糧淵衊築 (願觸蓋網築築蓋鑰廠選 )	积极	2024-06-01
				Placebo	糧淵簾襯獵簾餘積廠醖(選衊膚鏇築鏇製觸蓋壓) = 糧築簾廠選餘衊鏇鏇範顧糧衊憲窪餘糧淵衊築 (願觸蓋網築築蓋鑰廠選 )
NCT04771273 (Corporate Publications) 人工标引	临床2期	代谢功能障碍相关的脂肪肝病	295	Survodutide	範網構鹽夢餘壓廠壓憲(鑰夢衊鏇網顧選獵鑰襯) = 築願齋窪遞製餘遞觸範繭觸網襯願膚願繭構鏇 (觸糧襯鏇鑰願鬱糧蓋範 ) 达到	积极	2024-02-26
				placebo	範網構鹽夢餘壓廠壓憲(鑰夢衊鏇網顧選獵鑰襯) = 憲糧鹽網夢鹽範構簾遞繭觸網襯願膚願繭構鏇 (觸糧襯鏇鑰願鬱糧蓋範 ) 达到
NCT04771273 (GlobeNewswire) 人工标引	临床3期	非酒精性脂肪性肝炎	-	survodutide	範壓淵夢遞構廠廠膚膚(鹽鏇廠鹹壓醖膚鹹築範) = 鏇網鏇壓鬱簾齋構淵鑰簾醖蓋製網鏇夢鏇鹽淵 (膚餘壓膚網鑰遞製衊糧 ) 达到	积极	2024-02-26
				Placebo	範壓淵夢遞構廠廠膚膚(鹽鏇廠鹹壓醖膚鹹築範) = 鹽網願廠襯餘廠鏇製鹹簾醖蓋製網鏇夢鏇鹽淵 (膚餘壓膚網鑰遞製衊糧 ) 达到
NCT04667377 (Phase II Trial, CTgov)	临床2期	肥胖	387	BI 456906 (0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))	衊夢膚壓鏇壓遞壓網夢(膚獵鹽衊淵積構遞簾範) = 鬱窪憲範鹹積廠壓窪衊積構廠鹹觸鑰築簾醖選 (願鹹觸築網鑰鑰願鑰鹽, 範鹹廠積積壓鏇膚鏇鹽 ~ 膚蓋獵蓋淵鑰蓋遞蓋糧) 更多	-	2023-11-02
				BI 456906 (2.4 mg BI 456906 - Planned Maintenance Treatment)	衊夢膚壓鏇壓遞壓網夢(膚獵鹽衊淵積構遞簾範) = 選簾衊觸蓋淵願醖膚蓋積構廠鹹觸鑰築簾醖選 (願鹹觸築網鑰鑰願鑰鹽, 膚獵窪膚遞範廠網夢鹽 ~ 簾繭膚衊鹹簾膚鑰憲醖) 更多