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 8-10 months depending on how long the treatment is given. 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2025-03-26

申办/合作机构

Boehringer Ingelheim GmbH

NCT06772532

/ Completed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2025-02-10

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2024-12-02

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）

2025-06-09·JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM

Efficacy of GLP-1-based Therapies on Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis: A Systematic Review and Meta-Analysis.

Article

作者: Wang, Qinghua ; Prud'homme, Gerald J ; Ni, Yunzhi ; Wang, Zhihong ; Wang, Yahao ; Zhou, Yue

OBJECTIVE:

New therapies are urgently needed for the treatment of metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). We conducted this systematic review and meta-analysis to evaluate the therapeutic effects of glucagon-like peptide-1 receptor agonists (GLP-1RAs) on MASLD/MASH.

METHODS:

We searched PubMed, Embase and Cochrane Library database to identify randomized controlled trials (RCTs) that compared GLP-1RAs with placebo or active agents with respect to the efficacy in patients with MASLD/MASH. The effects of GLP-1RAs on liver fat content (LFC) by imaging, liver histology, serum liver enzymes, and noninvasive fibrosis indexes (fibrosis-4, NFS, CK-18, procollagen III and liver stiffness) were evaluated. Mean differences (MDs) and risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using a random-effect model.

RESULTS:

25 RCTs involving 2600 patients that used GLP-1RAs including liraglutide, exenatide, dulaglutide, semaglutide, tirzepatide, efinopegdutide, survodutide and retatrutide were included. Overall, GLP-1RAs treatment for a median of 24 weeks demonstrated a significant reduction in LFC by 5.21%, with the retatrutide displaying the most obvious treatment effects. GLP-1RAs treatment induced significant histological improvements in steatosis, hepatocellular ballooning and lobular inflammation, but non-significantly improved fibrosis, with the evidence for tirzepatide more robust than that for semaglutide and liraglutide. GLP-1RAs treatment significantly decreased serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and γ-glutamyl transferase (GGT) compared with control. GLP-1RAs also significantly improved liver stiffness, with semaglutide displaying the most obvious treatment effect. No drug-related adverse effects involving the liver was observed.

CONCLUSION:

GLP-1RAs decreased liver fat deposition and improved histological steatosis, hepatocellular ballooning and lobular inflammation, without worsening of fibrosis in MASLD and MASH.

2025-06-01·ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Review Article: GLP‐1 Receptor Agonists and Glucagon/GIP/GLP‐1 Receptor Dual or Triple Agonists—Mechanism of Action and Emerging Therapeutic Landscape in MASLD

Review

作者: Tavaglione, Federica ; Zafer, Maryam ; Loomba, Rohit ; Romero‐Gómez, Manuel

ABSTRACT:

Background:

Metabolic dysfunction‐associated steatotic liver disease (MASLD) is primarily managed through diet and lifestyle modifications. However, these behavioural interventions alone may not achieve disease regression or remission, and maintaining long‐term adherence is challenging. Incretin mimetics and other gastrointestinal hormones targeting the pleiotropic pathophysiological pathways underlying MASLD have now emerged as promising disease‐modifying therapies.

Aims:

This is a comprehensive review summarising the role of glucagon‐like peptide‐1 (GLP‐1) receptor agonists and glucagon/glucose‐dependent insulinotropic polypeptide (GIP)/GLP‐1 receptor dual or triple agonists in the treatment of metabolic dysfunction‐associated steatohepatitis (MASH).

Methods:

Only clinical trials with endpoints assessed by liver histology were included for a robust evaluation of therapeutic efficacy.

Results:

Recent evidence from phase 2 clinical trials for MASH demonstrated that pharmacological agents based on GLP‐1 receptor agonism are effective in improving disease activity. Additionally, tirzepatide and survodutide showed potential clinical benefits in reducing fibrosis. Other cardiometabolic benefits observed include weight loss and improvements in glycaemic control and lipid profile. Adherence to treatment may be limited by gastrointestinal side effects, though they were found to be generally mild to moderate in severity. An interim analysis of the semaglutide phase 3 trial confirmed its efficacy in improving steatohepatitis and demonstrated its potential to improve fibrosis.

Conclusions:

GLP‐1 receptor agonists, alone or in combination with GIP and/or glucagon receptor agonists, represent promising, effective pharmacotherapies for the treatment of MASLD/MASH. Larger and longer‐duration clinical trials are needed to further evaluate the efficacy and safety of GIP receptor and glucagon receptor agonism.

2025-05-01·PEPTIDES

Multifunctional incretin peptides in therapies for type 2 diabetes, obesity and associated co-morbidities

Review

作者: Flatt, Peter R ; Bailey, Clifford J ; Conlon, J Michael

Recent studies with peptide-based incretin therapies have focussed mainly on the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide and the dual agonist tirzepatide that engages receptors for GLP-1 and glucose-dependent insulinotropic polypeptide (GIP). Randomised clinical trials and 'real-world' studies have confirmed the marked glucose-lowering and weight-lowering efficacy of these agents across diverse populations. These include different ethnic groups, young and elderly individuals with and without diabetes and/or overweight or obesity. Recent studies have also confirmed protections against the development and progression of cardiovascular and renal diseases that are additive to the benefits conferred by improved control of blood glucose and body weight. Emerging evidence suggests that incretin therapies could additionally ameliorate fatty liver disease, chronic inflammation, sleep apnea and possibly degenerative bone disorders and cognitive decline. New incretin-based peptide therapies in development include a long-acting glucagon receptor agonist (LY3324954), dual GLP-1/glucagon receptor agonists (survodutide, pemvidutide, mazdutide, G49), triple GLP-1/GIP/glucagon receptor agonists (retatrutide, efocipegtrutide), a combination of semaglutide with the amylin analogue cagrilintide (CagriSema), a unimolecular GLP-1/amylin receptor dual agonist (amycretin), and a GIP receptor antibody with GLP-1 receptor agonism (MariTide). The creation of multi-targeting incretin-based synthetic peptides provides opportunities for improved management of type 2 diabetes and obesity as well as new therapeutic approaches to an expanding list of associated co-morbidities. The aim of the review is to acquaint the reader with developments in the field from 2023 to the present (February 2025).

246

项与 Survodutide 相关的新闻（医药）

2025-06-23

·药时代

未来，这三大新兴治疗领域存在巨大市场潜力

近年来，GLP-1受体激动剂的爆发式增长验证了"未满足临床需求驱动创新"的产业逻辑。这类药物通过多靶点作用机制（如葡萄糖依赖的胰岛素分泌、抑制胰高血糖素、延缓胃排空等），不仅解决了传统降糖药的低血糖风险和体重增加问题，还实现了心血管保护。而这种成功范式正在向代谢功能障碍相关脂肪性肝炎（MASH）、神经病理性疼痛、慢性炎症性脱髓鞘性多发性神经病（CIDP）三大领域传导。这些新兴治疗领域同样面临治疗手段匮乏、疾病负担沉重的困境，且已涌现出具备颠覆潜力的创新疗法，这些突破性治疗手段将为疾病领域带来巨大的市场潜力。表1 三大新兴治疗领域市场潜力概况注：公开资料，药智咨询整理（点击查看大图）MASH从“无药可医”到“治疗新纪元”代谢功能障碍相关的脂肪性肝炎（简称MASH）是非酒精性脂肪肝炎（nonalcoholic steatohepatitis, NASH）的更新命名，它是一种与代谢功能障碍密切相关的慢性肝病，其主要特征为肝细胞损伤和炎症，伴或不伴纤维化，显著增加肝硬化和肝细胞癌的发病风险。据悉，该疾病的全球患病率约为3%~5%，中国MASH患病率为25%~30%，领域内存在庞大的患者基数，但MASH的传统治疗上，多主要依靠生活方式干预、使用保肝药物、调脂药物等进行间接治疗，通常只能起到辅助治疗的作用，不能从根本上解决代谢紊乱的问题，改善肝纤维化病程。临床治疗上存在巨大缺口，缺乏直接治疗药物，一定程度上可谓“无药可医”。同时，再加上MASH病因复杂，自1980年起多数针对MASH的药物研发项目均以失败而告终，直到2024年3月才迎来FDA加速批准首个靶向药物Resmetirom。而也正是由于该药的突破性治疗让全球制药行业看到了MASH领域广阔的市场前景。2024年MASH的市场规模才6.9亿美元，据沙利文预测，2030年MASH的全球药物市场有望达到322亿美元。里程碑意义：Resmetirom开启MASH治疗新纪元Resmetirom（瑞美替罗）是由Madrigal制药公司研发的一种甲状腺激素受体-β（THR-β）选择性激动剂，通过激活肝脏中的THR-β受体，促进脂肪代谢、减少炎症和纤维化。2024年3月FDA批准Resmetirom联合饮食和运动，用于治疗患有中重度肝纤维化（F2～F3期）的非肝硬化MASH成人患者。这对长达40余年空白的MASH药物研发领域而言可谓一项重要的里程碑事件。其关键Ⅲ期试验MAESTRO-NASH（NCT03900429）显示：高剂量100mg Resmetirom可显著改善肝纤维化且缓解MASH疗效更好。2024上市首年销售额即达1.8亿美元，远超预期。若后续针对肝纤维化（F2-F4c）全阶段患者III期MAESTRO-NASH OUTCOMES试验成功，其市场还将进一步扩大。表2 Resmetirom获批上市关键Ⅲ期试验结果（52周）分组剂量主要终点1主要终点2不良事件发生率高剂量组N=323100 mg Resmetirom29.90%25.90%12.70%低剂量组N=32280 mg Resmetirom25.90%24.20%10.90%分组N=321安慰剂9.70%14.20%11.50%注：主要终点1为NASH缓解且无纤维化进展，主要终点2为纤维化缓解至少1期且NAS评分没有加重。在治疗优势方面，相比起间接保肝调脂治疗，Resmetirom通过选择性激活甲状腺激素受体β，精准作用于疾病关键病理环节，能够显著降低肝脏胆固醇合成，有效改善肝脏炎症状态，降低肝硬化风险。在竞争格局方面，已上市的Resmetirom占据先发优势，据Scrip公司预测2030年Resmetirom将占据整个市场的三分之一左右。目前全球治疗MASH的管线共有81条，涉及靶点包括THR-β、FGF21、GLP-1、PPAR、DGAT2等。针对纤维化改善且MASH未恶化的研究终点，疗效排序前三的药物为：Efruxifermin（61%）、Survodutide（52%）、Tirzepatide（48%）；针对MASH缓解且纤维化未恶化的终点，疗效排序前三的药物为：Efruxifermin（51%）、Survodutide（25%）、VK-2809（23%）。GLP-1类药物的加入，为MASH药物市场带来了巨大的增量。图1 各类产品MASH缓解且无纤维化恶化对比（安慰剂校正）来源：各公司官网披露数据图2 各类产品纤维化改善且无MASH恶化对比（安慰剂校正）来源：各公司官网披露数据神经性疼痛：去成瘾化非阿片类药物或许是未来趋势神经病理性疼痛[3]（neuropathic pain，NP）是指损伤或疾病影响到躯体感觉神经系统引起的疼痛，涉及糖尿病神经病变、带状疱疹后神经痛、纤维肌痛症等多种疾病。NP引起的疼痛持续存在或反复发作，给患者带来极大痛苦并造成功能障碍。NP在普通人群中患病率为3.0%～17.0%，随着全球老龄化加剧，神经性疼痛的发病率会持续上升。传统止痛药如阿片类药物因副作用和成瘾风险而备受争议，开发更安全、更有效的止痛药成为行业的重要方向。Suzetrigine未来或主导非阿片类神经性疼痛市场Suzetrigine（VX-548）是一款由Vertex制药公司开发的首创选择性钠通道（NaV1.8）抑制剂，通过高选择性抑制NaV1.8钠通道，作用于外周痛觉神经元阻断痛觉，不作用于阿片受体，从而避免成瘾性。2025年01月30日，FDA批准Suzetrigine上市，用于治疗中度至重度疼痛。该产品是20多年来首个获批的的新型镇痛药物，也是首个非阿片类口服疼痛信号抑制剂。Suzetrigine的获批标志着疼痛治疗从“中枢干预”转向“外周阻断”，这一策略可能开启多靶点镇痛药物的新时代。据Fortune Business预测，神经性疼痛市场预计将成为除MASH之外的第二大增长领域，2030年市场规模将达到143.5亿美元。在两项治疗中至重度急性疼痛的随机、双盲、安慰剂对照III期临床试验中，Suzetrigine在腹部整形术后和拇囊炎术后急性疼痛管理中表现出显著的镇痛效果和无成瘾风险，主要终点8小时内的时间加权疼痛强度差异（SPID48）分别为48.4、29.3。图3 Suzetrigine的关键III期临床试验结果来源：Vertex官网在治疗优势方面，相比阿片类镇痛药，Suzetrigine高选择性抑制周围感觉神经元，镇痛效果更显著，能快速持续镇痛，无成瘾性，具有良好的安全性和耐受性。在竞争格局方面，Suzetrigine镇痛机制极具创新力和临床价值较高，被行业媒体Evaluate列为潜在重磅疗法，有分析师预测2030年Suzetrigine可能会主导非阿片类神经性疼痛市场，年销售额将达51亿美元。目前，全球约有超40款靶向NaV1.8的在研新药正在开发针对疼痛的研究，有11款已进入临床阶段，其中国内有4款：恒瑞（II期）、上海济煜（II期）、费米子（I期）、海博为（I期），Suzetrigine是首款获批上市的此类药品。表3 全球处于临床阶段的NaV1.8抑制剂在研管线药物名称研发企业临床阶段适应症VX-548Vertex获批上市中重度疼痛；糖尿病周围神经痛HRS4800恒瑞医药Ⅱ期临床急、慢性疼痛JMKX000623上海济煜II期临床疼痛LTG-001LatigoII期临床疼痛PF-05089771辉瑞II期临床疼痛PF-4531083辉瑞II期临床疼痛VX-993VertexII期临床疼痛FZ008-145费米子科技I期临床疼痛HBW-004285海博为药业I期临床疼痛ODM-111OrionI期临床疼痛VX-961VertexI期临床疼痛注：药智数据、药智咨询管理CIDP：从传统治疗到靶向治疗，30年沉寂后的精准免疫疗法突破慢性炎性脱髓鞘性多发性神经根神经病[4]（chronic inflammatory demyelinating polyradiculoneuropathy，CIDP）是一类由免疫介导的罕见的脱髓鞘性周围神经病，患病率约为（0.67~10.30）/10万。虽然发病机制尚不清楚，但越来越多的证据表明IgG抗体在周围神经损伤中起着关键作用。CIDP的传统疗法（免疫球蛋白、激素）存在疗效波动、副作用显著、治疗负担高等局限性，且近30年来无新机制药物问世，近88%的患者经过治疗后仍会遗留功能障碍和残疾，患者疾病负担重，因此CIDP亟需更加有效、安全的治疗方法。Vyvgart Hytrulo强势破局，开启CIDP靶向治疗新时代Vyvgart Hytrulo（efgartigimod alfa/透明质酸酶）是一款由再鼎医药/Argenx合作研发的靶向新生儿Fc受体（FcRn）的拮抗剂，为皮下注射剂，通过阻断FcRn与IgG的结合，抑制IgG的循环再利用，加速其溶酶体降解，从而降低包括致病性自身抗体在内的所有IgG水平，能精准地仅降低IgG而不影响IgM/IgA，减少广泛免疫抑制风险。2024年6月21日，美国FDA批准了Argenx的Vyvgart Hytrulo用于CIDP的治疗，同年11月该适应症在中国获批上市。这是30多年来首个获得批准且具有明确作用机制的CIDP新疗法，也是中国首个获批CIDP适应症的靶向生物制剂，标志着中国CIDP治疗进入靶向治疗新时代。其关键临床II期ADHERE研究显示：与安慰剂相比，VYVGART Hytrulo可将复发风险降低61%，在中国亚组中降低复发风险达69%，明显延缓残疾进展达46.3%，耐受性和安全性良好。ADHERE研究披露出的显著疗效让Argenx总市值从不足10亿美元一路走高到300亿美元，可见资本市场还是比较青睐能精准填补临床治疗空白的药物。图4 Vyvgart Hytrulo关键临床研究数据来源：Argenx 官网在治疗优势方面，相比传统的免疫球蛋白、激素疗法，Vyvgart Hytrulo起效快速，能精准针对CIDP的发病机制进行治疗，能够显著改善患者的肌肉力量和活动能力，从而提高患者的生活质量，帮助患者更好地回归正常生活和工作。此外，Vyvgart Hytrulo采用皮下注射给药，与一些需要静脉输注的药物相比，患者可以在医生指导下自行注射或在门诊等场所进行注射，提高了用药的便利性和患者的依从性，减少了患者因静脉输注带来的不便和潜在风险，如感染、血管损伤等。在竞争格局方面，据Argenx官网显示Vyvgart Hytrulo共计有15项研究、涉及13个适应症正在开展临床研究，使得其隐约展现出“PIP药物“（Pipeline-in-a-pill）的潜质。据Scrip预测，预计CIDP 2030年的市场规模将达到33.6亿美元，Vyvgart Hytrulo凭借其优异的疗效和每周一次皮下注射的便捷性，有望替代传统静脉注射疗法成为CIDP的一线治疗方案，在2030年的市场规模中占到66%。目前治疗CIDP的靶向FcRn的产品共4个：Vyvgart Hytrulo、Batoclimab和Rozanolixizumab、Nipocalimab，经过对比，总体来说Vyvgart Hytrulo的疗效和安全性更高。表4 治疗CIDP的靶向FcRn的产品临床数据对比产品Vyvgart HytruloBatoclimab[6]Rozanolixizumab[7]Nipocalimab分期II期IIb 期IIa期/终止II/III期研发公司再鼎医药/Argenx石药/和铂医药优时比(UCB)制药强生疗效复发风险降低61%，明显延缓残疾进展达46.3%总体残疾评定量表（aINCAT）评分平均改善1.8分在总体残疾量表（iRODS）百分位数评分中未观察到试验组和对照组的显著差异暂未公布，预计2026年完成试验安全性不良事件多为轻中度胆固醇水平升高（潜在副作用）耐受性良好暂未公布注：文献研究，药智咨询整理结语GLP-1类药物在肥胖症领域的成功印证了一个真理，未被满足的临床需求是医药创新的核心驱动力。比如，Resmetirom的获批不仅终结了MASH领域40年的研发寒冬，更激活了百亿级市场的竞争活力；Suzetrigine以非阿片类机制重新定义疼痛管理，为饱受成瘾困扰的疼痛患者提供全新解决方案；Vyvgart Hytrulo则通过FcRn靶向机制实现CIDP治疗的精准突破，突破传统免疫疗法的局限。这些突破性疗法的里程碑意义为我们揭示了未来新药市场的增长逻辑，即以疾病的病理生物学为基础，以临床未满足需求为靶心，通过机制创新撬动市场蓝海，有望在未来十年助力新兴治疗领域市场规模快速增长。参考文献：1.After Obesity, What Are Biopharma’s Big Growth Markets?2.代谢相关脂肪性肝病基层诊疗与管理指南（2025年）3.中国神经病理性疼痛诊疗指南(2024版)4.慢性炎性脱髓鞘性多发性神经根神经病诊治中国专家共识20225.世界癌症日 | 脑胶质瘤的发病率与治疗目标6.https://natlawreview.com/press-releases/roivant-announces-positive-results-batoclimab-myasthenia-gravis-mg-and7.Querol L,et al. Efficacy, safety and tolerability of rozanolixizumab in patients with chronic inflammatory demyelinating polyradiculoneuropathy: a randomised, subject-blind, investigator-blind, placebo-controlled, phase 2a trial and open-label extension study. J Neurol Neurosurg Psychiatry. 2024 Aug 16;95(9):845-854.图片来源：豆包AI全球制药巨头TOP50排名揭晓：强生稳居榜首，中国药企表现亮眼2025-06-22FDA细胞和基因治疗部门两位高层被解雇2025-06-21BioNTech关闭细胞疗法工厂、裁员63人，实体瘤CAR-T前路何方？2025-06-20版权声明/免责声明本文为转载文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn点击这里，查看更多精彩！

突破性疗法临床3期加速审批ASH会议上市批准

2025-06-16

·FierceBiotech

South Korean biotech\'s GLP-1 drug scores MASH win while reducing weight

D&D Pharmatech’s CEO Seulki Lee, Ph.D., said results for its GLP-1 candidate DD01 were “remarkably positive … after only 12 weeks.”\n A South Korean biotech’s GLP-1 candidate has reduced liver fat in patients with metabolic dysfunction-associated steatohepatitis (MASH), with the added benefit of helping patients lose weight.D&D Pharmatech tested a once-weekly regimen of its dual GLP-1/glucagon receptor agonist DD01 in 67 overweight or obese patients with MASH. A total of 75.8% of patients who received DD01 saw a more than 30% reduction in liver fat after 12 weeks compared to 11.8% of patients who received placebo, hitting the study’s primary endpoint.Similar success was seen in the secondary endpoint of reducing liver fat by more than 50%, with 72.7% of the DD01 cohort achieving this compared to 5.9% of the placebo group. When it came to reducing liver fat by more than 70%, a total of 57.6% of DD01 patients were able to reach this endpoint compared to none of the placebo group, the biotech explained in a June 16 release.The drug also showed “encouraging” weight loss potential, said D&D, which noted that 42.4% of patients who received the therapy saw a greater than 5% reduction in weight, while “placebo-treated subjects had no significant weight loss.”Gastrointestinal side effects led three patients to discontinue treatment, although D&D said that, in general, these side effects were mild or moderate as well as being “transient and manageable.” MASH—previously known as nonalcoholic steatohepatitis—has proven an elusive target for pharma, but several drugmakers are starting to find increasing success in the metabolic liver disease, including via GLP-1 routes. Novo Nordisk is awaiting an FDA decision on approving semaglutide, the ingredient in its blockbuster GLP-1 weight loss drug Wegovy, for MASH after it demonstrated improvements in liver fibrosis in a phase 3 trial.There has also been promising MASH data from other GLP-1 drugs like Eli Lilly’s GIP/GLP-1 co-agonist tirzepatide and Boehringer Ingelheim’s glucagon/GLP-1 agonist survodutide.D&D’s CEO Seulki Lee, Ph.D., said the results for DD01 this morning were “remarkably positive … after only 12 weeks.”“The magnitude of improvements is equivalent to what has been achieved only after longer-term treatment with FGF and GLP-1 based drugs already validated with histology data in MASH,” Lee added. “Considering the combination of liver and metabolic benefits and the favorable tolerability profile, DD01 has the potential to provide patients and physicians with a MASH treatment that is easy to manage, encourages weight loss and is diabetes friendly.”

$South Korean biotech\'s GLP-1 drug scores MASH win while reducing weight$

临床结果临床3期

2025-06-16

·Firstwordpharma

South Korean biotech touts 'remarkably positive' results for MASH contender

A little known South Korean biotech said Monday that its experimental treatment yielded encouraging results in the race to treat metabolic dysfunction-associated steatohepatitis (MASH). D&D Pharmatech reported that DD01 hit the main goal of a Phase II trial — and investors took notice, sending the company's stock soaring to the 30% daily limit on Korea's KOSDAQ exchange.The once-weekly dual GLP-1/glucagon receptor agonist was evaluated in 67 overweight or obese individuals with MASH. Treatment began with a two-week lead-in 20-mg subcutaneous dose, followed by a maintenance dose of 40 mg administered once weekly.After 12 weeks, results showed that 75.8% of patients on DD01 had at least a 30% drop in liver fat, compared to 11.8% of those on placebo. The drug was associated with a 62.3% relative reduction in liver fat compared to 8.3% with placebo.Additionally, 72.7% of subjects had their liver fat reduced by half, compared to 5.9% for placebo; and 48.5% reached normalisation — defined as 5% or less — while no one in the placebo group reached that mark.Beyond liver fat reduction, DD01 also significantly improved liver stiffness and other non-invasive markers of disease, as well as body weight and HbA1c, although the study population was not selected to be diabetic.CEO Seulki Lee called the results "remarkably positive," and said that "the magnitude of improvements is equivalent to what has been achieved only after longer-term treatment with FGF and GLP-1 based drugs already validated with histology data in MASH."The treatment was generally well tolerated, though as with other GLP-1-based therapies, gastrointestinal (GI) side effects were most common. Three participants dropped out due to GI issues, but the company described events as "generally mild to moderate, but transient and manageable."Several companies have been vying for a piece of the MASH pie. Novo Nordisk's semaglutide, branded as Ozempic for diabetes and Wegovy for weight loss, recently succeeded in the Phase III ESSENCE trial, earning a priority review from US regulators for MASH.Eli Lilly's competing drug tirzepatide, sold as Mounjaro/Zepbound, also hit met the primary endpoint of the Phase II SYNERGY-NASH trial, while Boehringer Ingelheim's Zealand Pharma-partnered survodutide has shown promising mid-stage results. For a detailed overview, see – Vital Signs: Tracking the MASH queue for GLP-1 agonists.

临床2期临床结果临床3期优先审批临床失败

100 项与 Survodutide 相关的药物交易

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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	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
隐源性肝硬化	临床3期	智利	勃林格殷格翰（中国）投资有限公司	2024-11-12

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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	295	Survodutide (Survodutide 2.4 mg - Planned Maintenance Treatment)	淵鹹鬱憲襯範壓淵艱遞 = 積構顧鹽襯膚廠範築醖蓋窪齋選壓願膚淵艱築 (鹹觸餘窪願夢範網願鹽, 範觸醖憲襯簾夢網壓觸 ~ 餘簾膚築構範鏇顧蓋願) 更多	-	2024-12-03
				Survodutide (Survodutide 4.8 mg - Planned Maintenance Treatment)	淵鹹鬱憲襯範壓淵艱遞 = 繭夢鏇顧糧齋夢憲構蓋蓋窪齋選壓願膚淵艱築 (鹹觸餘窪願夢範網願鹽, 齋鏇壓襯鹹壓壓憲鬱選 ~ 遞淵壓鹹鏇鬱窪築齋襯) 更多
ESC2024	临床2期	肥胖	387	Survodutide 4.8 mg	積製獵遞範憲憲窪鹹築(積範窪餘憲膚餘廠餘範) = 獵願範願鬱憲夢餘範鑰範鹽襯願積構築憲憲鏇 (範繭構鑰壓淵鏇餘齋網 )	积极	2024-09-01
NCT04153929 \| NCT03591718 \| NCT04667377 (1665-P, ADA2024)	临床1/2期	2型糖尿病 \| 肥胖 HbA1c \| insulin sensitivity \| glucose biomarkers ... 更多	-	Survodutide	顧齋夢顧糧窪艱壓齋選(鹹衊蓋範構鬱憲網遞製) = 0.4 vs 0.0 窪簾艱構構艱鏇鬱壓鹽 (範膚齋鏇膚顧夢遞壓遞 ) 更多	积极	2024-06-14
				Placebo
NCT04771273 (1404-0043, Pubmed)	临床2期	非酒精性脂肪性肝炎	293	Survodutide 2.4 mg	鬱鏇積繭鹹膚範築獵觸(積鏇觸齋築積鹹鹽窪構) = 鬱積廠醖選夢糧憲餘鏇繭鏇積糧遞壓顧艱鑰鹽 (鑰夢網網鑰廠構窪製製 ) 更多	积极	2024-06-07
				Survodutide 4.8 mg	鬱鏇積繭鹹膚範築獵觸(積鏇觸齋築積鹹鹽窪構) = 淵餘積糧築糧窪齋鏇簾繭鏇積糧遞壓顧艱鑰鹽 (鑰夢網網鑰廠構窪製製 ) 更多
NCT04667377 (Phase II Trial, ENDO2024)	临床2期	超重 \| 肥胖	384	Survodutide 4.8 mg	積願鏇窪膚糧觸構簾窪(窪窪齋觸構觸膚齋廠廠) = 廠顧襯艱鏇顧構淵範製願顧襯構餘積範餘鹹製 (憲齋觸積襯醖網廠蓋觸 )	积极	2024-06-01
				Placebo	積願鏇窪膚糧觸構簾窪(窪窪齋觸構觸膚齋廠廠) = 餘艱壓觸網鏇夢築襯顧願顧襯構餘積範餘鹹製 (憲齋觸積襯醖網廠蓋觸 )
NCT04771273 (GlobeNewswire) 人工标引	临床3期	非酒精性脂肪性肝炎	-	survodutide	鑰膚憲鑰糧膚製鹹鹹簾(積糧衊顧顧願鏇齋鑰願) = 獵獵鏇膚構餘壓窪衊淵鹹築簾窪範遞範選餘艱 (膚餘築淵窪網鏇顧齋選 ) 达到	积极	2024-02-26
				Placebo	鑰膚憲鑰糧膚製鹹鹹簾(積糧衊顧顧願鏇齋鑰願) = 廠糧獵鑰窪餘顧網積鹹鹹築簾窪範遞範選餘艱 (膚餘築淵窪網鏇顧齋選 ) 达到
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	構鑰顧夢衊遞範醖齋積(醖餘網醖鑰膚獵鏇鏇積) = 襯淵觸願築蓋選遞醖築製壓窪蓋憲憲顧網獵衊 (鏇夢構製鑰獵餘遞齋醖 ) 达到	积极	2024-02-26
				placebo	構鑰顧夢衊遞範醖齋積(醖餘網醖鑰膚獵鏇鏇積) = 顧繭窪範壓膚襯製壓夢製壓窪蓋憲憲顧網獵衊 (鏇夢構製鑰獵餘遞齋醖 ) 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))	獵鹽廠壓襯製構艱艱壓(構襯淵廠膚鏇壓廠簾糧) = 製簾窪廠鬱積廠窪遞範築廠夢鬱齋繭夢構蓋醖 (鏇廠蓋網醖夢襯憲壓膚, 1.07) 更多	-	2023-11-02
				BI 456906 (2.4 mg BI 456906 - Planned Maintenance Treatment)	獵鹽廠壓襯製構艱艱壓(構襯淵廠膚鏇壓廠簾糧) = 鏇壓膚獵選繭鏇鏇簾醖築廠夢鬱齋繭夢構蓋醖 (鏇廠蓋網醖夢襯憲壓膚, 1.01) 更多
NCT04667377 (ADA2023) 人工标引	临床2期	超重 \| 肥胖	387	BI 456906 0.6 mg	選鬱鹹鬱願鑰鹽願廠壓(選範製廠選壓鑰獵顧蓋) = 淵積構鹽鹽鬱廠夢窪鬱積鏇蓋選築淵淵糧鏇鑰 (觸鑰遞膚鏇鏇鑰願窪衊 ) 更多	积极	2023-06-23
				BI 456906 2.4 mg	選鬱鹹鬱願鑰鹽願廠壓(選範製廠選壓鑰獵顧蓋) = 範繭夢淵憲醖網獵齋繭積鏇蓋選築淵淵糧鏇鑰 (觸鑰遞膚鏇鏇鑰願窪衊 ) 更多
NCT04153929 (Phase II, CTgov)	临床2期	2型糖尿病	413	Placebo (Placebo)	襯夢鏇艱繭鑰築廠願壓(遞顧壓構築顧齋鑰鏇顧) = 廠鑰積淵窪願鑰壓願鹽積觸構築衊醖遞鬱鹽餘 (築膚蓋構構夢觸築觸艱, 0.81) 更多	-	2022-11-29
				BI 456906 (BI 456906 0.3 mg)	襯夢鏇艱繭鑰築廠願壓(遞顧壓構築顧齋鑰鏇顧) = 餘構艱選網鬱壓獵淵築積觸構築衊醖遞鬱鹽餘 (築膚蓋構構夢觸築觸艱, 0.71) 更多