Phase 2b Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of MAR001 in Patients With Elevated Triglycerides and Remnant Cholesterol (TYDAL-TIMI 78)

The primary objective of the study is to evaluate the effect of MAR001 compared to placebo on levels of the TG and RC in adults with elevated TG and RC.

开始日期2025-06-01

申办/合作机构

Marea Therapeutics Pty Ltd.

[+1]

NCT05896254

/ Completed临床1/2期

A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of MAR001 in Patients With Metabolic Dysfunction

The purpose of this study is to evaluate the safety and tolerability of multiple doses of MAR001in adult volunteers with metabolic dysfunction.

开始日期2023-07-22

申办/合作机构

Marea Therapeutics Pty Ltd.

100 项与 MAR-001 相关的临床结果

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100 项与 MAR-001 相关的转化医学

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100 项与 MAR-001 相关的专利（医药）

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项与 MAR-001 相关的文献（医药）

2025-07-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Maresin 1 attenuates myocardium ischemia/reperfusion injury via SIRT1/HMGB-1/NLRP-3-related mechanisms

Article

作者: Li, Xin ; Zhong, Peng ; Luo, Xing-Jun ; Ding, Hua-Sheng ; Liu, Xiao-Xiong ; Luo, Zhi-Hui ; Huang, Zhong-Yi ; Qu, Ji-Fu

BACKGROUND AND PURPOSE:

Maresin 1 (MaR 1) has demonstrated potent anti-inflammatory and antioxidant effects in different animal models. However, its impact on heart ischemia/reperfusion injury (IRI) remains uncertain. Pyroptosis, a pro-inflammatory programmed cell death, is associated with IRI. The goal of our research was to assess the role of MaR 1 on pyroptosis during heart IRI mice.

METHODS:

Cardiac IRI was induced in a mouse model, and hypoxia/reoxygenation (H/R) was conducted on neonatal rat ventricle myocytes (NRVMs) to establish an in vitro model. The effects of MaR 1 were assessed using measures such as cardiac infarct area, heart tissue injury, hemodynamic monitoring, apoptotic index, pyroptosis-related proteins, inflammatory reaction and heart enzyme activities.

RESULTS:

MaR 1 injection obviously reduced cardiac infarct area and apoptosis, inhibited myocardial pyroptosis, decreased pro-inflammatory cytokines and suppressed apoptosis via Silent information regulator factor 2-related enzyme 1 (SIRT1). Additionally, MaR 1 injection markedly suppressed the expression of High-mobility group box 1 (HMGB-1)/nuclear factor-κB (NF-κB)/(NOD)-like receptor Pyrin domain-containing 3 (NLRP-3) axis-related proteins by SIRT1. In isolated NRVMs, MaR 1 increased cellular viability, diminished heart enzyme activities and inhibited apoptosis and inflammation. Furthermore, in vitro studies demonstrated that the SIRT1 inhibitor decreased the anti-inflammatory and anti-apoptosis properties of MaR 1 in NRVMs through the HMGB-1/NF-κB/NLRP-3 axis.

CONCLUSION:

Our research suggests that MaR 1 pretreatment may alleviate cardiac IRI and suppress pyroptosis and apoptosis both in vivo and in vitro. MaR 1 inhibits pyroptosis through the SIRT1/HMGB-1/NF-κB/NLRP-3 axis. Therefore, MaR 1 may serve as a promising treatment for cardiac IRI.

2025-05-01·LANCET

Safety and efficacy of a novel ANGPTL4 inhibitory antibody for lipid lowering: results from phase 1 and phase 1b/2a clinical studies

Article

作者: Weiss, Ethan J ; Cummings, Beryl B ; Hirman, Joe ; Joing, Mark P ; Basson, Craig T ; Siegelman, Evan S ; Lehrer-Graiwer, Joshua ; Trauger, John W ; Juliano, Rebecca A ; Maratos-Flier, Eleftheria ; Milton, Mark N ; Hom, Douglas ; Flaherty, Meghan M ; Splawski, Igor ; Yi, B Alexander ; Nimonkar, Amitabh V ; Moesta, Peter F ; Meyers, Daniel ; O'Donnell, Chris ; Ramanan, Vyas ; Sahambi, Sukhdeep K ; Garrett, Chris E ; Huet, Francois ; Lane, Andrew ; Hinder, Markus ; Yates, Denise P ; Bouchard, Page R ; Voznesensky, Andrei

BACKGROUND:

Genetic studies have established angiopoietin-related protein 4 (ANGPTL4) as a key regulator of triglyceride metabolism and a promising target to reduce atherosclerotic cardiovascular disease (ASCVD) risk beyond traditional risk factors. Human ANGPTL4 loss-of-function shows no adverse consequences and is associated with reduced triglycerides and remnant cholesterol, and a reduced risk of type 2 diabetes and ASCVD. Nonetheless, development of ANGPTL4 inhibitors has been delayed due to adverse findings in ANGPTL4-knockout mice fed a high saturated fat diet, including lipid accumulation in mesenteric lymph nodes, systemic inflammation, adverse clinical signs, and reduced survival. We previously reported the development and preclinical characterisation of MAR001, an ANGPTL4 inhibitory antibody. Here, we report a comprehensive safety assessment of ANGPTL4 inhibition, including novel analysis of genetic ANGPTL4 loss on mesenteric lymph node architecture in humans and two early-phase clinical trials.

METHODS:

MAR001 was evaluated in a first-in-human, randomised, placebo-controlled, single-ascending-dose phase 1 study with three parts in which participants received a single subcutaneous injection of MAR001 or placebo. The study was developed and conducted by Novartis Biomedical Research (Cambridge, MA, USA). Eligible participants enrolled in part 1A were healthy men and women aged between 18 years and 65 years with a bodyweight of at least 50 kg and a BMI of 18-30 kg/m². Participants in part 1B weighed at least 70 kg and had a BMI of 30-40 kg/m². Participants in part 1C weighed at least 59 kg and had fasting triglycerides in the range of 200-500 mg/dL. The primary objectives were to assess the safety and tolerability of a single subcutaneous injection of MAR001 up to and including 141 days post-dose and to assess the pharmacokinetics of single-dose subcutaneous administration in healthy participants. MAR001 was subsequently assessed in a randomised, double-blind, placebo-controlled phase 1b/2a study in participants with metabolic dysfunction. The study was done at two sites in Australia. Eligible participants were adults with hypertriglyceridaemia (in the screening range of ≥1·7 mmol/L and ≤5·6 mmol/L; ≥151 mg/dL and ≤496 mg/dL) and a history of type 2 diabetes, or a screening homeostatic model assessment for insulin resistance (HOMA-IR) value greater than 2·2 and abdominal obesity (defined as waist circumference >88 cm for women and >102 cm for men; > 80 cm for Asian women and >90 cm for Asian men). The primary objective was to characterise the safety and tolerability of multiple doses of MAR001 in participants with metabolic dysfunction. The phase 1b/2a study is registered with ClinicalTrials.gov, NCT05896254.

FINDINGS:

We found no evidence of clinical adversity in human germline ANGPTL4 loss-of-function, adding to preclinical support for initiating human studies. Between Nov 20, 2017, and Sept 10, 2019, in the first-in-human, randomised, placebo-controlled, single-ascending-dose phase 1 study, part 1A enrolled 32 healthy participants: six each received 15 mg, 50 mg, 150 mg, or 450 mg of MAR001, and eight received placebo. Part 1B enrolled 12 participants: nine received 450 mg of MAR001 and three received placebo. Part 1C enrolled 12 participants: eight received 450 mg of MAR001 and four received placebo. Between Nov 24, 2013, and July 1, 2024, in the multidose phase 1b/2a randomised, double-blind, placebo-controlled study, 55 participants were randomly assigned to receive subcutaneous injections of placebo (19 participants) or MAR001 at doses of 150 mg (ten participants), 300 mg (nine participants), or 450 mg (17 participants), followed by a 12-week safety follow-up period. MAR001 was safe and generally well tolerated, and we observed no treatment-related systemic inflammatory biomarker elevations or changes in mesenteric lymph node size or inflammation assessed by MRI. MAR001 (450 mg) yielded placebo-adjusted week 12 mean reductions in triglycerides of 52·7% (90% CI -77·0 to -28·3) and in remnant cholesterol of 52·5% (-76·1 to -28·9).

INTERPRETATION:

ANGPTL4 inhibition with MAR001 can safely and effectively reduce circulating triglycerides and remnant cholesterol. The findings of these trials support further research and development of MAR001 as a promising potential lipid-lowering therapy to reduce risk of ASCVD.

FUNDING:

Marea Therapeutics.

2024-02-01·Zhonghua wei zhong bing ji jiu yi xue

[Research progress on the organ-protective effect of Maresin-1 in sepsis].

Review

作者: Moxiang, Gong ; Tang, Lili ; Li, Xiaoyue ; Su, Zhiyong ; Chen, Qiao

Sepsis is a fatal organ dysfunction caused by the uncontrolled inflammatory response of the host to infection. Excessive inflammatory reaction is the core factor in the occurrence and development of sepsis, the degree of organ dysfunction is directly related to the prognosis of sepsis. Timely intervention of excessive inflammatory response and alleviation of organ function damage are essential to improve the prognosis of sepsis. Maresin-1 (MaR-1) is a newly discovered endogenous specific pro-inflammatory resolution mediator, which plays a role of anti-inflammatory, pro-inflammatory regression and organ protection in sepsis, and may be a new target for the treatment of sepsis. This article reviews the research progress of the role of MaR-1 in the regulation of inflammation and organ protection in sepsis, in order to provide reference for the clinical development of new drugs for the treatment of sepsis.

项与 MAR-001 相关的新闻（医药）

2025-05-16

·医学新视点

《柳叶刀》：血脂、残余胆固醇双双降低超50%！用药一周，即可显著降脂

血管生成素样蛋白4（ANGPTL4）是血管内皮生长因子家族成员，主要在脂肪和肝脏表达，其可通过抑制脂蛋白脂肪酶活性而调节脂质代谢。遗传学研究已明确，ANGPTL4是甘油三酯代谢的关键调节因子，也是降低动脉粥样硬化心血管疾病（ASCVD）风险的具有前景的靶点。MAR001是一种潜在“first-in-class”的单克隆抗体，靶向在脂肪组织中高度表达的ANGPTL4蛋白。MAR001可通过抑制ANGPTL4，优先增强脂肪组织中的脂蛋白脂肪酶活性，降低残余胆固醇水平，改善脂肪组织和代谢功能，并减少心血管事件。近日，《柳叶刀》（The Lancet）发表的一项研究结果表明，在代谢功能障碍参与者中[高甘油三酯血症、2型糖尿病病史或胰岛素抵抗稳态模型（HOMA-IR）＞2.2且腹部肥胖]，450 mg MAR001用药12周后，可将甘油三酯水平显著降低52.7%、残余胆固醇水平降低52.5%。研究结果支持MAR001是一种具有前景的潜在降脂疗法，有待进一步开发和研究，以造福更多的患者。截图来源：The Lancet本次公布了1期研究和1b/2a期研究结果。1期试验是MAR001的首次人体、随机、安慰剂对照、单次剂量递增研究，共分为1a（健康人群）、1b[高体重指数（BMI）人群]和1c（高血脂人群）三个部分，所有参与者（56例）均随机接受MAR001或安慰剂治疗，主要目的是评估单次皮下注射MAR001至用药后141天的安全性和耐受性。1a部分纳入体重≥50 kg且BMI在18~30 kg/m2、年龄18~65岁的成人健康参与者32例，其中各有6例参与者分别接受15 mg、50 mg、150 mg和450 mg的MAR001，以及各有2例参与者分别接受匹配的安慰剂；1b部分纳入体重≥70 kg且BMI在30~40 kg/m2成人参与者12例，其中9例接受450 mg的MAR001，3例接受匹配的安慰剂；1c部分纳入体重≥59 kg、空腹甘油三酯水平在200~500 mg/dL的参与者12例，其中8例参与者接受450 mg的MAR001，4例接受匹配的安慰剂。研究结果显示，在1c（高血脂人群）参与者中，用药后第2天参与者的空腹甘油三酯水平即明显降低，且在第15天达到最大降幅。▲高血脂人群使用MAR001（蓝色）和安慰剂（红色）后，空腹甘油三酯水平变化情况（图片来源：参考文献[1]）用药后第15天时，在1c（高血脂人群）参与者中，空腹甘油三酯水平相较于基线降低了47.2%（90%CI：-61.0%~-33.4%）。校正安慰剂影响后，MAR001可使甘油三酯水平和残余胆固醇水平分别降低68.6%（90%CI：-97.4%~-39.8%）和65.5%（90%CI：-94.2%~-36.9%）。▲高血脂人群使用MAR001（蓝色）和安慰剂（红色）后，残余胆固醇水平变化情况（图片来源：参考文献[1]）此外，由于1a（健康人群）和1b（高BMI人群）参与者基线时空腹甘油三酯水平均正常，因此，使用450 mg MAR001在降低空腹甘油三酯水平方面的作用较弱，也未降低餐后甘油三酯水平。所有剂量的MAR001安全性均可控且患者耐受性良好。研究未报告有死亡病例、严重不良事件。所有56例参与者中，有19例（34%）至少发生一起不良事件，其中17例（30%）共发生23起轻度不良事件、2例（3.6%）共发生3起中度不良事件。随后，研究人员在一项针对代谢功能障碍参与者的随机、双盲、安慰剂对照1b/2a研究中，评估MAR001的用药安全性和耐受性。该研究纳入高甘油三酯血症（甘油三酯水平≥151 mg/dL且≤496 mg/dL）、2型糖尿病病史或HOMA-IR＞2.2且腹部肥胖成人参与者55例。其中10例参与者接受了150 mg MAR001、9例参与者接受300 mg MAR001、17例参与者接受450 mg MAR001，以及19例参与者接受安慰剂治疗，治疗期为12周（每2周皮下注射一次，共注射7次），而后是为期12周的安全随访。基线时，接受MAR001治疗的患者甘油三酯水平在169.9 mg/dL~219.2 mg/dL。研究结果显示，治疗第12周时，使用MAR001的参与者甘油三酯水平和残余胆固醇水平呈现剂量依赖性降低，且用药第一周即可观察到明显降幅，高剂量MAR001在用药后第6周可达到最大降幅。校正安慰剂影响后，接受150 mg MAR001、300 mg MAR001、450 mg MAR001的参与者甘油三酯水平分别较基线降低40.6%（90%CI：-70.1%~-11.2%）、50.3%（90%CI：-88.0%~-12.7%）和52.7%（90%CI：-77.0%~-28.3%）；残余胆固醇水平分别较基线降低37.4%（90%CI：-66.1%~-8.8%）、49.3%（90%CI：-85.8%~-12.8%）和52.5%（90%CI：-76.1%~-28.9%）。▲150 mg MAR001组（蓝色）、300 mg MAR001组（紫色）、450 mg MAR001组（绿色）和安慰剂组（红色）甘油三酯（图A）和残余胆固醇（图B）水平变化趋势（图片来源：参考文献[1]）此外，校正安慰剂影响后，治疗第12周，450 mg MAR001参与者非高密度脂蛋白胆固醇（non-HDL-C）水平降低7.1%（90%CI：-14.7%~-0.6%），高密度脂蛋白胆固醇（HDL-C）水平升高了19%（90%CI：10.2%~27.8%）。安全性方面，MAR001安全性可控且患者耐受性良好，未观察到有严重不良事件或致命不良事件的发生，发生不良事件的参与者比例也未表现出剂量依赖性增加趋势。仅有1例参与者（安慰剂组）因不良事件停止参与研究，多数不良事件均为1级或2级，可自行缓解。MAR001未引发新的肠系膜炎症，也无患者出现腹水。《柳叶刀》发表的同期社论指出，该研究探索了新型疗法在降低甘油三酯和残余胆固醇方面的作用。在此之前，医学界已经探索了载脂蛋白C3（APOC3）和血管生成素样蛋白3（ANGPTL3）抑制剂的作用，可分别用于治疗家族性乳糜微粒血症和纯合子家族性高胆固醇血症，但ANGPTL4抑制剂在人体中的作用研究始终较少，部分原因是在小鼠实验中观察到ANGPTL4抑制剂的安全耐受性有待提升。本次研究未观察到接受MAR001治疗的参与者有可检测到的肠系膜淋巴数量增多或淋巴结增大问题。未来仍需开展大型随机对照试验，来明确使用ANGPTL4抑制剂后患者的临床获益情况，获益不仅包含降低脂质水平，还应涵盖ASCVD风险和糖尿病风险是否有所降低。总之，本次研究结果显示，在基线高甘油三酯水平的人群中使用MAR001，可有效降低甘油三酯水平和残余胆固醇水平，且整体用药安全性可控，患者耐受性良好。点击文末“阅读原文/Read more”，即可访问The Lancet官网阅读完整论文。推荐阅读欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。参考资料[1] Beryl B Cummings, Mark P Joing, Page R Bouchard, et al. Safety and efficacy of a novel ANGPTL4 inhibitory antibody for lipid lowering: results from phase 1 and phase 1b/2a clinical studies. Published Online May 15, 2025. The Lancet. http://doi.org/10.1016/S0140-6736(25)00825-6.[2] Anders B Wulff. Safely lowering triglycerides through ANGPTL4 inhibition. Published Online May 15, 2025. The Lancet. https://doi.org/10.1016/S0140-6736(25)00988-2. 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「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com分享，点赞，在看，传递医学新知

临床结果临床1期

2025-05-07

·药明康德

首次！重磅ADC临床3期结果优于标准疗法；胆固醇降幅超80%！体内基因疗法亮眼结果公布……

首次！重磅抗体偶联药物（ADC）3期结果优于标准疗法今日，阿斯利康（AstraZeneca）与第一三共（Daiichi Sankyo）宣布，双方联合开发的重磅抗体偶联药物Enhertu（trastuzumab deruxtecan）在DESTINY-Breast11临床3期试验当中取得积极结果。分析显示，在高风险、局部晚期HER2阳性早期乳腺癌患者中，于术前新辅助治疗阶段使用Enhertu联合紫杉醇、曲妥珠单抗和帕妥珠单抗（THP），在病理完全缓解（pCR）方面相较于标准治疗方案（剂量密集的阿霉素和环磷酰胺，后使用THP，即ddAC-THP）实现了具有统计学显著性和临床意义的提升。病理完全缓解被定义为治疗后在切除的乳腺组织和淋巴结中未发现浸润性癌细胞。根据新闻稿，这是首个3期临床试验证实Enhertu在早期乳腺癌中具有治疗益处。此外，Enhertu联合疗法亦展现出相较标准治疗方案更优的安全性。尽管在分析时无事件生存期（EFS）这一次要终点尚未成熟，但数据显示Enhertu联合THP在EFS方面相较标准治疗呈现出早期积极趋势。试验将继续随访EFS结果。Enhertu是阿斯利康和第一三共联合开发的ADC疗法。它采用第一三共专有的DXd ADC技术平台设计，由靶向HER2的人源化单克隆抗体通过四肽可裂解连接子，与拓扑异构酶1抑制剂有效载荷连接组成。胆固醇降幅超80%！体内基因疗法亮眼结果公布CRISPR Therapeutics日前公布其在研、ANGPTL3靶向体内肝脏基因编辑疗法CTX310，在其首个人体剂量递增临床1期试验的积极结果。该研究共纳入四类血脂异常患者群体，包括纯合子家族性高胆固醇血症（HoFH）、严重高甘油三酯血症（sHTG）、杂合子家族性高胆固醇血症（HeFH）及混合型血脂异常（MDL）患者。截至2025年4月16日，已有来自四个剂量组的10名患者完成至少30天随访。结果显示，单次给药后，CTX310可实现剂量依赖性地降低患者的ANGPTL3、甘油三酯（TG）和低密度脂蛋白胆固醇（LDL-C）水平。研究数据显示，接受剂量水平3与4患者的ANGPTL3平均值较基线下降最多达75%。CTX310在各剂量水平下均具有良好的耐受性，未观察到与治疗相关的严重不良事件，也无3级及以上不良事件发生。在肝功能相关指标及血小板计数方面，未见临床意义上的变化或剂量依赖性趋势。▲CTX310临床1期试验的结果摘要（图片来源：参考资料[2]）部分个体患者的应答结果亮眼：一位接受剂量水平4的sHTG患者，在第30天时，其TG水平下降达82%（基线TG为1073 mg/dL）；另一位接受剂量水平3的HeFH患者，其LDL-C水平在第90天下降了81%（基线LDL-C为256 mg/dL）。这些结果表明CTX310在高风险人群中具有潜在的靶向疗效。潜在“first-in-class”单抗亮眼2期试验结果公布Marea Therapeutics公司今日在欧洲动脉粥样硬化学会（EAS）年会上，公布了其在研、潜在“first-in-class”的ANGPTL4靶向单抗MAR001在2a期临床试验中的亮眼数据。根据此积极结果，公司预计将于2025年第二季度启动2b期临床试验。这项随机、双盲、安慰剂对照2a期试验的主要目的是评估MAR001在高甘油三酯及高残余胆固醇患者中多次给药的安全性与耐受性。该试验共纳入55名空腹甘油三酯水平在151至496 mg/dL之间的高甘油三酯血症患者，按2：1比例随机分配至每两周给药一次的MAR001组或安慰剂组。▲MAR001临床2a期试验的结果摘要（图片来源：参考资料[3]）结果显示，在第12周时，MAR001可使残余胆固醇的安慰剂校正后平均降幅最高达到52.5%，甘油三酯的降幅则最高达到52.7%。在基线甘油三酯水平显著升高（≥200 mg/dL）的受试者中，在第12周时，MAR001对残余胆固醇和甘油三酯的安慰剂校正后平均降幅分别可达66.0%和64.0%。MAR001同时展现良好的耐受性。参考资料：[1] Enhertu followed by THP before surgery showed statistically significant and clinically meaningful improvement in pathologic complete response in patients with high-risk HER2-positive early-stage breast cancer in DESTINY-Breast11 Phase III trial. Retrieved May 7, 2025 from https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-improved-pcr-in-early-stage-breast-cancer.html[2] CRISPR Therapeutics Provides First Quarter 2025 Financial Results and Announces Positive Top-Line Data from Phase 1 Clinical Trial of CTX310™ Targeting ANGPTL3. Retrieved May 7, 2025 from https://ir.crisprtx.com/news-releases/news-release-details/crispr-therapeutics-provides-first-quarter-2025-financial[3] Marea Therapeutics Presents Positive Data from Phase 2a Clinical Trial of MAR001, Being Developed for Cardiovascular Disease, in Late-Breaking Oral Session at the 93rd EAS Congress. Retrieved May 7, 2025 from https://www.mareatx.com/press-releases/marea-therapeutics-presents-positive-data-from-phase-2a-clinical-trial-of-mar001-being-developed-for-cardiovascular-disease-in-late-breaking-oral-session-at-the-93rd-eas-congress/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

临床结果临床3期基因疗法抗体药物偶联物

2025-05-07

·Endpoints

Marea heads to Phase 2b after updated biomarker data show CV drug’s promise

Marea Therapeutics said on Wednesday that its lipid-lowering antibody cut both remnant cholesterol levels and remnant triglycerides — both indicators for cardiovascular disease in at-risk patients. The highest dose tested in the Phase 2a trial of MAR001 (450 mg injected every two weeks) cut remnant cholesterol levels by 52.5%, adjusted for placebo, after three months. This is a more precise figure than the “around 50%” the company disclosed earlier when it released topline data in January. The placebo-adjusted remnant cholesterol reductions with the lower 300 mg and 150 mg doses were 49.3% and 37.4%, respectively. Remnant cholesterol is defined as the total cholesterol level minus the low- and high-density lipoprotein cholesterol (LDL and HDL, the so-called “bad and “good” cholesterol). New data also came on the other efficacy endpoint in the trial: remnant triglycerides. The high dose of MAR001 cut levels of these fatty molecules by 52.7%, on a placebo-adjusted basis, at the three-month mark. The placebo-adjusted remnant triglyceride reductions were 50.3% and 40.6% with the medium and low doses, respectively. In subjects with significantly elevated triglycerides at baseline, the high dose of MAR001 reduced remnant cholesterol and remnant triglycerides by 66% and 64%, respectively, when adjusted for placebo. The detailed results were presented on Wednesday at the European Atherosclerosis Society’s congress in Glasgow, Scotland. Marea now plans to push MAR001 into Phase 2b trials by midyear. In order to gain approval for cardiovascular risk reduction, however, the company will have to run an outcomes study, chief scientific officer and co-founder Ethan Weiss told Endpoints News via email. It is planning to do so, and the Phase 2b study will help determine the dose for the Phase 3 study, he said. The company launched just under a year ago, having licensed the ANGPTL4-targeted antibody from Novartis. ANGPTL4 is a protein highly expressed in adipose tissue and linked to increased risk of heart disease. The antibody was safe and well-tolerated in the Phase 2a, Marea said. There were no deaths or serious adverse events in any arm, and none of the 55 trial participants stopped taking MAR001 because of adverse events.

临床2期临床结果

100 项与 MAR-001 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
高甘油三酯血症	临床2期	美国	Marea Therapeutics Pty Ltd.	2025-06-01
高甘油三酯血症	临床2期	澳大利亚	Marea Therapeutics Pty Ltd.	2025-06-01
动脉粥样硬化	临床2期	澳大利亚	Marea Therapeutics Pty Ltd.	-

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适应症

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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


NCT05896254 (NEWS \| Pubmed) 人工标引	临床1/2期	高甘油三酯血症	-	MAR001 (phase 1)	鹹醖顧網構顧範齋蓋蓋(夢壓鑰繭襯觸築艱壓淵) = 餘鏇鹽糧襯鑰壓齋齋鬱醖簾鬱齋選遞憲遞糧範 (窪鹽願範遞築顧鹹鑰遞, -61.0 ~ -33.4)	积极	2025-05-16
				Placebo (phase 1)	-
NCT05896254 (BusinessWire) 人工标引	临床2期	心血管疾病	55	MAR001 (150mg)	製蓋遞獵醖願獵壓鏇顧(糧衊醖築選糧膚積鏇壓) = 齋觸鑰醖衊觸蓋獵糧淵願製襯廠憲醖鹹蓋廠鏇 (製糧築餘構廠積獵窪網 ) 更多	积极	2025-05-07
				MAR001 (300 mg)	製蓋遞獵醖願獵壓鏇顧(糧衊醖築選糧膚積鏇壓) = 鬱鏇網遞廠糧願構願觸願製襯廠憲醖鹹蓋廠鏇 (製糧築餘構廠積獵窪網 ) 更多
NCT05896254 (PipelineReview) 人工标引	临床2期	高甘油三酯血症	55	MAR001	鑰淵遞鹽網鑰築糧選獵(壓獵淵壓憲糧鹽簾餘網) = MAR001 at 300mg and 450mg demonstrated approximately 50% placebo-corrected remnant cholesterol lowering in the target population. 選網糧繭齋製鹹夢繭淵 (襯餘醖廠廠鹽鏇淵願網 ) 更多	积极	2025-01-10
				Placebo