An Open-label, Randomized, Parallel-group, Single-center Trial to Compare Pharmacokinetics of Dapiglutide After a Single Subcutaneous Dose of the Drug Product Concentrations 10 mg/mL or 25 mg/mL in Participants With Overweight or Obesity

This is a phase 1, open-label, single-center, randomized, parallel-group trial designed to investigate the pharmacokinetic profiles, safety, and tolerability of a single dose administration of 7.5 mg dapiglutide administered s.c. with two drug product concentrations, 10 mg/mL and 25 mg/mL. The trial will be conducted in participants with a BMI ≥ 27.0 kg/m2.

开始日期2024-12-23

申办/合作机构

Zealand Pharma A/S

[+1]

CTIS2024-516901-21-00

/ Not yet recruiting临床1期

- ZP7570-24026

开始日期2024-12-23

申办/合作机构

Zealand Pharma A/S

NCT06000891

/ Terminated临床1期

A Randomised, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570 Administered in Subjects With Overweight or Obesity

The trial is a Phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in Part 1 in a semi-parallel design and one cohort in Part 2 in overweight and obese but otherwise healthy subjects, randomised to ZP7570 or placebo within each cohort where the observational period is 18 weeks for Part 1 and 28 weeks for Part 2. All subjects will be dosed for 13 weeks in Part 1 and for 28 weeks in Part 2 with ascending weekly doses of ZP7570 at dose levels with corresponding volume of placebo.

开始日期2023-09-15

申办/合作机构

Zealand Pharma A/S

[+1]

100 项与 Dapiglutide 相关的临床结果

登录后查看更多信息

100 项与 Dapiglutide 相关的转化医学

登录后查看更多信息

100 项与 Dapiglutide 相关的专利（医药）

登录后查看更多信息

项与 Dapiglutide 相关的文献（医药）

2022-08-01·Annals of the New York Academy of Sciences

The dual GLP‐1 and GLP‐2 receptor agonist dapiglutide promotes barrier function in murine short bowel

Article

作者: Held, Jascha ; Witte, Maria ; Eriksson, Per‐Olof ; Reiner, Johannes ; Vollmar, Brigitte ; Jaster, Robert ; Berlin, Peggy ; Skarbaliene, Jolanta ; Lamprecht, Georg ; Thiery, Johanna

Abstract:

Short bowel syndrome can occur after extensive intestinal resection, causing intestinal insufficiency or intestinal failure, which requires long‐term parenteral nutrition. Glucagon‐like peptide‐2 (GLP‐2) pharmacotherapy is now clinically used to reduce the disease burden of intestinal failure. However, many patients still cannot be weaned off from parenteral nutrition completely. The novel dual GLP‐1 and GLP‐2 receptor agonist dapiglutide has previously been shown to be highly effective in a preclinical murine short bowel model. Here, we studied the effects of dapiglutide on intestinal epithelial barrier function. In the jejunum, dapiglutide increased claudin‐7 expression and tightened the paracellular tight junction leak pathway. At the same time, dapiglutide promoted paracellular tight junction cation size selectivity in the jejunum. This was paralleled by extension of the cation selective tight junction proteins claudin‐2 and claudin‐10b and preserved claudin‐15 expression and localization along the crypt–villus axis in the jejunum. In the colon, no barrier effects from dapiglutide were observed. In the colon, dapiglutide attenuated the short bowel–associated, compensatorily increased epithelial sodium channel activity, likely secondary, by improved volume status. Future studies are needed to address the intestinal adaptation of the colon.

2022-07-01·JPEN. Journal of parenteral and enteral nutrition2区 · 医学

Dapiglutide, a novel dual GLP‐1 and GLP‐2 receptor agonist, attenuates intestinal insufficiency in a murine model of short bowel

2区 · 医学

Article

作者: Jaster, Robert ; Russell, Wayne ; Eriksson, Per‐Olof ; Reiner, Johannes ; Vollmar, Brigitte ; Thiery, Johanna ; Witte, Maria ; Held, Jascha ; Berner‐Hansen, Mark ; Ehlers, Luise ; Berlin, Peggy ; Skarbaliene, Jolanta ; Griffin, Jonathan ; Lamprecht, Georg

Abstract:

Background:

Extensive intestinal resection may lead to short bowel (SB) syndrome, resulting in intestinal insufficiency or intestinal failure (IF). Intestinal insufficiency and IF involve deficiency of the proglucagon‐derived hormones glucagon‐like peptide‐1 (GLP‐1) and GLP‐2. Two major problems of SB are epithelial surface loss and accelerated transit. Standard treatment now targets intestinal adaptation with a GLP‐2 analogue to enlarge absorptive surface area. It is possible that additional benefit can be gained from a combination of GLP‐1 and GLP‐2 activity, with the aim to enlarge intestinal surface area and slow intestinal transit.

Methods:

The GLP‐1– and GLP‐2–specific effects of the novel dual GLP‐1 receptor (GLP‐1R) and GLP‐2 receptor (GLP‐2R) agonist dapiglutide (rINN) were characterized in rodents. Furthermore, in a murine SB model of intestinal insufficiency with 40% ileocecal resection, the influence of dapiglutide on intestinal growth, body weight, food intake, volume status, and stool water content was tested against vehicle and sham‐operated male mice.

Results:

Dapiglutide significantly improves oral glucose tolerance, reduces intestinal transit time, and promotes intestinal growth. In the SB mouse model, dapiglutide promotes body weight recovery, despite unchanged intake of liquid diet. Dapiglutide promotes significant intestinal growth, as indicated by significantly increased villus height as well as intestinal length. Furthermore, dapiglutide reduces stool water losses, resulting in reduced plasma aldosterone.

Conclusion:

Dapiglutide possesses specific and potent GLP‐1R and GLP‐2R agonist effects in rodents. In the murine SB model, combined unimolecular GLP‐1R and GLP‐2R stimulation with dapiglutide potently attenuates intestinal insufficiency and potentially also IF.

项与 Dapiglutide 相关的新闻（医药）

2025-06-22

·药明康德

3个月一次，降低发作率95%的单抗疗法；使超80%肿瘤患者获完全缓解的靶向疗法…… | 一周盘点

本期看点1. 潜在“first-in-class”突变型钙网蛋白（mutCALR）靶向单克隆抗体早期临床数据积极，超80%骨髓增殖性肿瘤（MPN）患者达完全缓解（CR）。2. 血浆激肽释放酶单抗抑制剂navenibart用于治疗遗传性血管性水肿，在一项早期临床试验中使患者每月的发作率大幅降低，平均降幅达92%，降幅中位数达97%。INCA033989：公布首个临床研究数据Incyte近日公布其创新疗法INCA033989的首个临床研究数据，该药物为一款潜在“first-in-class”、mutCALR靶向单克隆抗体，用于治疗携带此突变的骨髓增殖性肿瘤患者。数据显示，在接受INCA033989治疗的高危原发性血小板增多症（ET）的患者中，各剂量组均实现了快速且持久的血小板计数正常化，高剂量组（>400 mg）患者应答更为显著。其中，86%的患者达到完全或部分血液学缓解，82%达CR；89%（34/38）的可评估患者mutCALR等位基因频率（VAF）降低，且21%（8/38）患者在仅接受3个治疗周期后即实现超过50%的VAF下降。单细胞DNA测序探索性研究进一步显示，INCA033989能够选择性靶向并减少携带mutCALR的造血干祖细胞（CD34阳性）及髓红系细胞，同时促进正常（野生型CALR）细胞的恢复，支持健康造血功能的重建。骨髓活检结果亦验证了这一机制，mutCALR阳性巨核细胞减少、阴性巨核细胞增加。安全性方面，INCA033989在24至2500 mg的全部剂量范围内耐受性良好，无剂量限制性毒性（DLT），仅1例患者因治疗伴发不良事件（TEAEs）停药，另有1例发生剂量调整。最常见的TEAEs为疲劳（26.5%）和上呼吸道感染（20.4%），均为1-2级。Navenibart（STAR-0215）：公布1b/2期临床试验长期开放标签试验的数据Astria Therapeutics公司公布了其血浆激肽释放酶单抗抑制剂navenibart治疗遗传性血管性水肿的1b/2期临床试验长期开放标签试验的数据。此次公布的结果显示，患者每月的发作率大幅降低，平均降幅达92%，降幅中位数达97%。频率为每3个月给药一次组别患者的平均每月发作率降低了95%，而每6个月给药一次组别患者的平均降幅为86%。安全性方面，navenibart总体耐受性良好，无严重的治疗伴发不良事件，无停药现象。ELVN-001：公布1期临床试验的新数据Enliven Therapeutics公司公布其小分子激酶抑制剂ELVN-001治疗慢性粒细胞白血病（CML）患者的1期临床试验的新数据。ELVN-001是一种强效、高选择性、潜在“best-in-class”的小分子激酶抑制剂，专门针对CML患者的致癌驱动因子BCR-ABL融合蛋白。ELVN-001还具有针对耐药性最强的BCR-ABL1耐药突变体T315I和其他已知耐药突变体的活性。截至2025年4月28日的数据，在53例可评估的患者中，47%（25/53）在24周时达到主要分子学缓解（MMR），其中最后一线治疗时对酪氨酸激酶抑制剂（TKI）耐药的患者中有41%（14/34）在24周时处于MMR，曾接受asciminib或ponatinib治疗的患者中也有35%（12/34）在24周时处于MMR。所有达到或维持MMR的患者在数据截止时仍保持缓解。在该临床试验中所纳入的患者群体此前接受过大量治疗的情况下，ELVN-001与已获批的针对BCR-ABL融合蛋白的TKI在1期试验中所观察到的MMR相比，结果依然更好。安全性方面，ELVN-001在所有剂量水平上继续表现出良好的安全性和耐受性。BMF-500：公布1期临床试验的初步数据Biomea Fusion公司公布了其共价FLT3抑制剂BMF-500治疗复发/难治性急性白血病的初步临床数据。BMF-500是一种新型、口服可利用的、高效、具选择性的FLT3共价小分子抑制剂。此前的研究表明，BMF-500潜在的脱靶风险较小，对活化的FLT3突变（包括FLT3-ITD和各种酪氨酸激酶结构域突变）具有皮摩尔级的亲和力。在携带FLT3-ITD突变的急性髓系白血病（AML）小鼠模型中，BMF-500使小鼠的肿瘤完全消退，且不需要持续暴露即可维持疗效。BMF-500在治疗FLT3突变的复发/难治性急性白血病患者中表现出令人鼓舞的初步疗效。在可评估的11例FLT3突变患者中，9人出现骨髓原始细胞下降，5人降幅超过50%。同时，在FLT3野生型患者中也观察到疾病控制效果。所有接受治疗的FLT3突变患者（n=18）的中位总生存期（mOS）为3.8个月（无CYP3A4抑制剂）和3.5个月（有CYP3A4抑制剂）。该数据优于历史对照数据，接受过gilteritinib和venetoclax治疗失败后的复发/难治性FLT3突变AML患者的历史mOS仅为2.1个月。BMF-500在各个剂量水平上总体耐受良好，未报告剂量限制性毒性、QT间期延长或因治疗相关不良事件导致的停药。Misetionamide（GP-2250）：公布1期临床试验的中期数据Panavance Therapeutics公司公布了其小分子疗法misetionamide（GP-2250）联用吉西他滨治疗晚期不可切除或转移性胰腺导管腺癌患者1期临床试验的中期数据。Misetionamide具有独特的作用机制，可抑制两种致癌转录因子c-MYC和NFκB。此次公布的结果显示，与单独使用吉西他滨的历史结果相比，接受misetionamide联用吉西他滨治疗患者的确认的缓解率、疾病稳定率和无进展生存期更优，约42%的患者达到部分缓解或疾病稳定。此外，misetionamide联用吉西他滨的安全性良好，与单独使用吉西他滨的预期毒性相比，没有明显的新毒性或加剧的毒性。参考资料（可上下滑动查看）[1] Enliven Therapeutics Announces Updated Positive Data from Phase 1 Clinical Trial of ELVN-001 in CML at EHA 2025 Congress. Retrieved June 20, 2025, from https://www.prnewswire.com/news-releases/enliven-therapeutics-announces-updated-positive-data-from-phase-1-clinical-trial-of-elvn-001-in-cml-at-eha-2025-congress-302481050.html[2] Beam Therapeutics Announces New Data from BEACON Phase 1/2 Clinical Trial of BEAM-101 Supporting Differentiated Profile in Sickle Cell Disease (SCD) at European Hematology Association (EHA) 2025 Congress. Retrieved June 20, 2025, from https://www.globenewswire.com/news-release/2025/06/13/3098931/0/en/Beam-Therapeutics-Announces-New-Data-from-BEACON-Phase-1-2-Clinical-Trial-of-BEAM-101-Supporting-Differentiated-Profile-in-Sickle-Cell-Disease-SCD-at-European-Hematology-Associatio.html[3] U.S. Food & Drug Administration (FDA) Approves Investigational New Drug (IND) Application for Myrio's Lead Product (PHOX2B PC-CAR T) for the Treatment of Neuroblastoma. Retrieved June 20, 2025, from U.S. Food & Drug Administration (FDA) Approves Investigational New Drug (IND) Application for Myrio's Lead Product (PHOX2B PC-CAR T) for the Treatment of Neuroblastoma[4] Intellia Therapeutics Announces Positive Three-Year Data from Phase 1 Trial of Lonvoguran Ziclumeran (lonvo-z) in Patients with Hereditary Angioedema (HAE) at the European Academy of Allergy and Clinical Immunology Congress. Retrieved June 20, 2025, from https://www.globenewswire.com/news-release/2025/06/15/3099489/0/en/Intellia-Therapeutics-Announces-Positive-Three-Year-Data-from-Phase-1-Trial-of-Lonvoguran-Ziclumeran-lonvo-z-in-Patients-with-Hereditary-Angioedema-HAE-at-the-European-Academy-of-A.html[5] Vial Initiating Phase 1 Healthy Volunteer Trial of VIAL-TL1A-HLE, a Novel Subcutaneous Half-Life Extended Anti-TL1A Antibody for the Treatment of IBD and Other Inflammatory and Fibrotic Diseases. Retrieved June 20, 2025, from https://vial.com/updates/pr/vial-initiating-phase-1-healthy-volunteer-trial-of-vial-tl1a-hle/?[6] Lyell Immunopharma Announces Positive New Clinical Data Demonstrating High Rates of Durable Complete Responses from the Phase 1/2 Trial of LYL314 for the Treatment of Aggressive Large B-cell Lymphoma. Retrieved June 20, 2025, from https://www.globenewswire.com/news-release/2025/06/17/3100483/0/en/Lyell-Immunopharma-Announces-Positive-New-Clinical-Data-Demonstrating-High-Rates-of-Durable-Complete-Responses-from-the-Phase-1-2-Trial-of-LYL314-for-the-Treatment-of-Aggressive-La.html[7] Azitra Reports Promising Safety Data from Phase 1b Trial in Netherton Syndrome. Retrieved June 20, 2025, from https://www.prnewswire.com/news-releases/azitra-reports-promising-safety-data-from-phase-1b-trial-in-netherton-syndrome-302483136.html[8] 882-P - Eloralintide, a Selective, Long-Acting Amylin Receptor Agonist for Obesity—Phase 1 Proof of Concept. Retrieved June 16, 2025 from https://eppro02.ativ.me/src/EventPilot/php/express/web/planner.php?id=ADA25[9] Positive Late-Breaking Data for Incyte’s First-in-Class mutCALR-targeted therapy INCA033989 in Essential Thrombocythemia Presented at EHA2025. Retrieved June 16, 2025 from https://investor.incyte.com/news-releases/news-release-details/positive-late-breaking-data-incytes-first-class-mutcalr-targeted[10] Oncoinvent Announces Positive Final Data from Phase 1/2a Trial of Radspherin® in Patients with Colorectal Peritoneal Metastases. Retrieved June 16, 2025 from https://www.prnewswire.com/news-releases/oncoinvent-announces-positive-final-data-from-phase-12a-trial-of-radspherin-in-patients-with-colorectal-peritoneal-metastases-302484870.html[11] Zealand Pharma announces positive topline results from 28-week Phase 1b trial with GLP-1/GLP-2 receptor dual agonist dapiglutide. Retrieved June 16, 2025 from https://www.globenewswire.com/news-release/2025/06/18/3101731/0/en/Zealand-Pharma-announces-positive-topline-results-from-28-week-Phase-1b-trial-with-GLP-1-GLP-2-receptor-dual-agonist-dapiglutide.html[12] Spyre Therapeutics Announces Positive Interim Phase 1 Results for Two Next-Generation TL1A Antibody Programs, and Provides Clinical Development Updates Expected to Deliver 9 Phase 2 Readouts. Retrieved June 20, 2025 from https://www.prnewswire.com/news-releases/spyre-therapeutics-announces-positive-interim-phase-1-results-for-two-next-generation-tl1a-antibody-programs-and-provides-clinical-development-updates-expected-to-deliver-9-phase-2-readouts-302483628.html[13] Centessa Pharmaceuticals Announces Clearance of Investigational New Drug Application (IND) for ORX142, a Novel Orexin Receptor 2 (OX2R) Agonist; Clinical Data in Acutely Sleep-Deprived Healthy Volunteers Planned for this Year. Retrieved June 20, 2025 from https://investors.centessa.com/news-releases/news-release-details/centessa-pharmaceuticals-announces-clearance-investigational-new[14] Eolo Pharma Publishes First-in-Human Study in Nature Metabolism on Novel Obesity Drug Activating Energy-Burning Pathway. Retrieved June 20, 2025 from https://www.globenewswire.com/de/news-release/2025/06/16/3099684/0/en/Eolo-Pharma-Publishes-First-in-Human-Study-in-Nature-Metabolism-on-Novel-Obesity-Drug-Activating-Energy-Burning-Pathway.html[15] Debiopharm’s ADC Research Gains Momentum With Launch of First-in-human Trial Assessing Debio 1562M in Acute Myeloid Leukemia Patients. Retrieved June 20, 2025 from https://www.businesswire.com/news/home/20250616081884/en/Debiopharms-ADC-Research-Gains-Momentum-With-Launch-of-First-in-human-Trial-Assessing-Debio-1562M-in-Acute-Myeloid-Leukemia-Patients[16] Biomea Fusion Presents Updated Preliminary Clinical Data for Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia at EHA 2025. Retrieved June 20, 2025 from https://investors.biomeafusion.com/news-releases/news-release-details/biomea-fusion-presents-updated-preliminary-clinical-data#:~:text=The%20presentation%20by%20Dr.%20Farhad%20Ravandi%20of%20The,inhibitor%2C%20in%20heavily%20pretreated%20patients%20with%20R%2FR%20AL.[17] Panavance Therapeutics Announces Promising Misetionamide (GP-2250) Phase 1 Clinical Trial Interim Findings in Pancreatic Cancer at BIO 2025. Retrieved June 20, 2025, from https://panavance.com/press/panavance-therapeutics-announces-promising-misetionamide-gp-2250-phase-1-clinical-trial-interim-findings-in-pancreatic-cancer-at-bio-2025/[18] Astria Therapeutics Announces Positive Initial Results from the ALPHA-SOLAR Long-Term Open-Label Trial of Navenibart in Hereditary Angioedema Patients at the European Academy of Allergy and Clinical Immunology Annual Congress. Retrieved June 20, 2025, from https://ir.astriatx.com/news-releases/news-release-details/astria-therapeutics-announces-positive-initial-results-alpha[19] Johnson & Johnson's dual-targeting CAR T-cell therapy shows encouraging first results in large B-cell lymphoma. Retrieved June 20, 2025, from https://www.prnewswire.com/news-releases/johnson--johnsons-dual-targeting-car-t-cell-therapy-shows-encouraging-first-results-in-large-b-cell-lymphoma-302480701.html[20] Galapagos Presented New Data at ICML 2025 From Cohort 3 of ATALANTA-1 in Relapsed/Refractory Indolent NHL Patients, Demonstrating High Complete Response and MRD Negativity Rates With CAR-T Candidate GLPG5101. Retrieved June 20, 2025, from https://www.globenewswire.com/news-release/2025/06/18/3101896/0/en/Galapagos-Presented-New-Data-at-ICML-2025-From-Cohort-3-of-ATALANTA-1-in-Relapsed-Refractory-Indolent-NHL-Patients-Demonstrating-High-Complete-Response-and-MRD-Negativity-Rates-Wit.html免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。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2

临床结果临床2期

2025-06-21

·生物制品圈

Zealand 公司 GLP-1/GLP-2 药物减重超 11% 且潜力待挖

近日，Zealand Pharma 公司的实验性肥胖治疗药物 dapiglutide 在早期研究中展现出了令人瞩目的成果，经过 28 周的治疗，患者体重减轻超过 11%。不过，分析师认为这一数据可能还未能完全展现该药物的真正减重潜力。一、研究数据亮眼但或被低估William Blair 的分析师在周三向投资者发布的报告中指出，Zealand 公司的这项研究存在 “非典型患者特征”。研究中 93% 的参与者为男性，而通常女性在减重治疗中往往能取得更显著的效果，因此报告中的减重数据可能在更具代表性的人群中被低估了。同时，与其他肥胖试验不同，该研究参与者的基线体重相对较低，平均为 91.9 公斤，这可能加剧了对 dapiglutide 减重功效的低估。这项顶线结果来自于一项 1b 期多剂量递增研究的第二部分，该研究共招募了 30 名患者，分别给予 dapiglutide 或安慰剂。在 28 周的治疗后，使用 dapiglutide 的患者平均体重下降了 11.6%，而安慰剂组患者体重仅下降了 0.2%。值得注意的是，在研究过程中，患者并未被要求进行包括饮食或运动在内的生活方式改变。二、药物安全性与耐受性良好研究显示，dapiglutide 具有良好的安全性和耐受性，未出现严重或重度的治疗突发不良事件。其副作用与肠促胰岛素类疗法一致，大多为轻度或中度。这为该药物后续的临床研究和应用奠定了良好的基础。三、独特配方或可靶向炎症dapiglutide 的配方中包含 GLP - 2，分析师认为这一成分有助于靶向炎症。肥胖引发的炎症会增加心血管疾病、肝脏疾病和神经炎症的风险，而 dapiglutide 通过 GLP - 2 改善肠道屏障功能，可能在解决与体重相关的合并症，如肠漏等方面发挥特别的作用。四、肥胖产品线持续扩充凭借此次 dapiglutide 的研究成果，Zealand 公司进一步充实了其肥胖产品线。该公司的肥胖产品线以淀粉样蛋白类似物 petrelintide 为主打，该产品目前正在进行针对超重和肥胖 2 型糖尿病患者的 IIb 期开发。2024 年 6 月发布的 Ib 期数据显示，经过 16 周的治疗，患者平均体重减轻了 8.6%。今年 3 月，罗氏公司豪掷 16.5 亿美元，并承诺在达到特定里程碑时支付最高 24 亿美元，以获取 petrelintide 的共同开发和共同商业化权利。罗氏和 Zealand 将在美国和欧洲平分利润和损失，而在其他地区，罗氏将负责运营，并向 Zealand 支付分级两位数的特许权使用费。William Blair 的分析师在周三的报告中表示，他们相信 Zealand 凭借其主要资产 petrelintide 在肥胖领域占据市场份额具有良好的前景，该候选药物在 Ib 期研究中已显示出令人鼓舞的初始减重和安全性数据。随着 dapiglutide 研究的推进以及 petrelintide 与罗氏合作的开展，Zealand 公司在肥胖治疗药物研发领域的表现值得持续关注，其能否为肥胖患者带来更多有效的治疗选择，我们拭目以待。原文来源：https://www.biospace.com/drug-development/zealands-glp-1-glp-2-drug-elicits-over-11-weight-loss-with-the-potential-for-more识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明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不本站。

临床结果临床2期

2025-06-19

·药明康德

减掉的85%是脂肪！单抗疗法完成临床概念验证；体重下降11.6%！多肽疗法积极数据公布……

Incyte单抗再获FDA批准Incyte近日宣布，其CD19靶向单抗Monjuvi（tafasitamab）已获得美国FDA批准，与利妥昔单抗和来那度胺联合用于治疗复发或难治性滤泡性淋巴瘤（FL）成人患者。此次批准主要基于关键3期inMIND研究的积极结果。Monjuvi是一种Fc结构经修饰的人源化单克隆抗体，能够靶向表达在B细胞表面的CD19分子。inMIND试验是一项随机、双盲、安慰剂对照的3期研究，旨在评估Monjuvi联合利妥昔单抗和来那度胺在FL患者中的疗效和安全性。研究结果显示其达到主要终点：Monjuvi治疗组的无进展生存期（PFS）显著优于对照组，疾病进展或死亡事件发生率为27.5%（N=273），而对照组为47.6%（N=275），中位PFS分别为22.4个月与13.9个月（HR=0.43，P<0.0001）。独立评审委员会与研究者评估结果一致，进一步支持了其临床意义。Monjuvi的疗效优势在多项预设亚组中保持一致，包括既往接受治疗的线数等关键因素，显示出该联合方案在临床应用中的广泛潜力。体重下降11.6%！多肽疗法积极数据公布Zealand Pharma日前公布其GLP-1/GLP-2双重受体激动剂dapiglutide的1b期多剂量递增（MAD）临床试验第二部分取得积极顶线结果。该研究评估dapiglutide在连续28周给药下的安全性、耐受性及临床效果，共纳入30名肥胖或超重受试者。受试者按2：1比例随机接受每周一次dapiglutide或安慰剂治疗。在第28周，dapiglutide组的平均体重较基线下降11.6%，而安慰剂组仅下降0.2%。值得注意的是，试验未包含任何饮食或运动干预，显示dapiglutide本身在体重控制方面的潜力。安全性方面，本阶段研究使用了高于此前13周第一部分研究的剂量，仍被评估为安全且耐受性良好。未报告任何严重或重度治疗伴发不良事件（TEAEs），绝大多数不良事件为轻度，以胃肠道反应如恶心和呕吐最为常见。减掉的几乎全是脂肪！单抗疗法完成临床概念验证Scholar Rock宣布其肌生长抑制素（myostatin）靶向单抗apitegromab在2期概念验证试验EMBRAZE中取得积极结果。该研究评估了apitegromab联合葡萄糖依赖性促胰岛素多肽（GIP）和GLP-1受体双重激动剂tirzepatide，在体重下降过程中对瘦体重（lean mass）的保护作用。数据显示，接受apitegromab和tirzepatide联合治疗超过24周的患者，与单独使用tirzepatide相比，瘦体重减少的幅度降低了4.2磅（p=0.001）。联合组受试者平均脂肪减少18.8磅，与单用tirzepatide组的17.7磅相近；总减重量略少，为12.3%（vs. 13.4%），但脂肪与瘦体重损失的比例更优（减少体重中，脂肪丢失的占比分别为85%与70%）。这一结果表明，apitegromab能够有效减少瘦体重流失，实现更优的减重质量。Apitegromab整体耐受性良好，其安全性与此前临床研究中观察到的一致，为进一步临床开发提供有力支持。参考资料：[1] Incyte Announces FDA Approval of Monjuvi® (tafasitamab-cxix) in Combination with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma. Retrieved June 19, 2025 from https://investor.incyte.com/news-releases/news-release-details/incyte-announces-fda-approval-monjuvir-tafasitamab-cxix[2] Zealand Pharma announces positive topline results from 28-week Phase 1b trial with GLP-1/GLP-2 receptor dual agonist dapiglutide. Retrieved June 19, 2025 from https://www.globenewswire.com/news-release/2025/06/18/3101731/0/en/Zealand-Pharma-announces-positive-topline-results-from-28-week-Phase-1b-trial-with-GLP-1-GLP-2-receptor-dual-agonist-dapiglutide.html[3] Scholar Rock Reports Positive Phase 2 EMBRAZE Trial Results Demonstrating Statistically Significant Preservation of Lean Mass with Apitegromab During Tirzepatide-Induced Weight Loss. Retrieved June 19, 2025 from https://investors.scholarrock.com/news-releases/news-release-details/scholar-rock-reports-positive-phase-2-embraze-trial-results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期临床2期

100 项与 Dapiglutide 相关的药物交易

登录后查看更多信息

研发状态

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
炎症	临床2期	丹麦	Zealand Pharma US, Inc.	2023-04-27
肥胖	临床2期	丹麦	Zealand Pharma US, Inc.	2023-04-27

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06000891 (GlobeNewswire) 人工标引	临床1期	超重 \| 肥胖	30	Dapiglutide	製齋夢網網積範積觸鹹(遞餘鑰夢醖糧膚鑰淵鏇) = 淵積繭鏇衊壓鬱鬱觸顧顧醖廠觸範鹽窪鬱糧鹽 (網願襯壓網繭壓廠糧鏇 )	积极	2025-06-18
				Placebo	製齋夢網網積範積觸鹹(遞餘鑰夢醖糧膚鑰淵鏇) = 餘齋廠範積鏇鬱壓製簾顧醖廠觸範鹽窪鬱糧鹽 (網願襯壓網繭壓廠糧鏇 )
NCT06000891 (GlobeNewswire) 人工标引	临床1期	超重 \| 肥胖	54	Dapiglutide	範選鬱鹹艱獵願願築鹹(夢鹹願蓋觸鏇窪繭夢窪) = 顧衊廠夢襯鑰鏇鏇範糧廠遞製鏇願糧齋網積積 (襯廠鹽構憲淵齋廠鬱願 ) 更多	积极	2024-09-09
				Placebo	範選鬱鹹艱獵願願築鹹(夢鹹願蓋觸鏇窪繭夢窪) = 憲餘糧夢廠簾築築遞鹽廠遞製鏇願糧齋網積積 (襯廠鹽構憲淵齋廠鬱願 )
ADA2024	N/A	-	-	Dapiglutide 6 mg	選網顧製遞網壓鏇簾鹹(構遞廠憲夢衊淵衊顧簾) = 鹹鑰窪製簾願築淵鑰夢艱構窪蓋壓糧選淵襯簾 (願鑰淵淵醖鬱艱窪獵鏇 )	-	2024-06-14
GlobeNewswire 人工标引	临床1期	肥胖	-	Dapiglutide	糧範憲製獵壓鹽艱鏇齋(淵襯鏇蓋網獵齋齋廠憲) = 窪襯範醖網鏇選鬱艱獵蓋積觸窪鏇簾築醖鹹範 (糧醖艱範鏇齋艱窪獵顧 )	积极	2022-06-06
ADA2022	N/A	-	40	Dapiglutide 1 mg	糧醖膚夢鬱壓膚鏇糧觸(壓築願網願餘鏇鹽襯鹹) = 鏇觸構繭衊築窪鬱襯構鹹醖夢廠顧窪構廠鬱蓋 (壓壓築壓鏇糧襯蓋蓋壓 )	-	2022-06-01
				Dapiglutide 2.25 mg	糧醖膚夢鬱壓膚鏇糧觸(壓築願網願餘鏇鹽襯鹹) = 鏇醖襯製觸衊餘糧構積鹹醖夢廠顧窪構廠鬱蓋 (壓壓築壓鏇糧襯蓋蓋壓 )