A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Itraconazole and Cyclosporine on the Single-Dose Pharmacokinetics of Danuglipron in Healthy Adult Participants

The purpose of this study is to see how single dose of cyclosporine and multiple doses of itraconazole affect the level of the study medicine danuglipron in the blood of healthy adult participants. The information from this study may inform how danuglipron will be used in the future with medicines like cyclosporine and itraconazole.

开始日期2024-12-16

申办/合作机构

Pfizer Inc.

NCT06567327 / Recruiting临床1期

A TWO-PART PHASE 1, OPEN- LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE MULTIPLE DOSE PHARMACOKINETICS OF DANUGLIPRON FOLLOWING ORAL ADMINISTRATION AND THE EFFECTS OF STEADY-STATE DANUGLIPRON ON THE PHARMACOKINETICS OF SINGLE ORAL DOSE OF ATORVASTATIN AND ROSUVASTATIN IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY

The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese:
* how the study medicine, danuglipron, is taken up into the blood
* if the study medicine, danuglipron, changes how the body processes other study medicines (Atorvastatin and Rosuvastatin)
* about the safety and tolerability of danuglipron
The study will take place in 2 Cohorts (groups). The total number of weeks of the study is about 23 (about 6 months) for Cohort 1 and 22 weeks (about 5.5 months) for Cohort 2.

开始日期2024-08-28

申办/合作机构

Pfizer Inc.

NCT06568731 / Active, not recruiting临床1期

A PHASE 1, OPEN- LABEL STUDY TO EVALUATE THE MULTIPLE DOSE PHARMACOKINETICS OF DANUGLIPRON FOLLOWING ORAL ADMINISTRATION IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY

开始日期2024-08-23

申办/合作机构

Pfizer Inc.

100 项与 Danuglipron 相关的临床结果

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100 项与 Danuglipron 相关的转化医学

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100 项与 Danuglipron 相关的专利（医药）

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项与 Danuglipron 相关的文献（医药）

2024-11-01·TOXICOLOGY AND APPLIED PHARMACOLOGY

Toxicology profile of a novel GLP-1 receptor biased agonist-SAL0112 in nonhuman primates

Article

作者: Sun, Jingchao ; Xiao, Ying ; Shen, Xiaolei ; Hu, Xuefeng ; Luo, Binbin ; Zhang, Hongmei ; Huang, Jing ; Ren, Zhiqiang ; Chen, Shu ; Jiang, Rongzhi

Oral small-molecule GLP-1 receptor biased agonists exhibit promising treatment efficacy of type 2 diabetes and obesity. SAL0112 is a novel compound that has demonstrated remarkable efficacy in preclinical animal models. Herein, both in vitro and in vivo preclinical toxicity investigations were conducted to explore the safety profile of SAL0112. The HTRF assay and TR-FRET assay were utilized for cAMP detection. Patch clamp assay was employed for hERG potassium ion channel determination. Cynomolgus monkeys were used in a cardiovascular safety pharmacology study and a 13-week repeated dose toxicity study. The telemetry system was employed to detect cardiovascular indicators such as ECG, HR, and BP. During the repeated dose toxicity study, body weight, food intake, hematology, coagulation function test, serum biochemistry tests, and urine analysis were measured. Macroscopic and microscopic observations were conducted at the end of the study. TK studies were conducted on Day 1 and Day 91. SAL0112 exhibited a high degree of potency in activating the monkey GLP-1 receptor whereas had no effect on the rodent GLP-1 receptor. In contrast to Danuglipron, which demonstrated high potency on hERG with an IC₅₀ value of 6.9 μM, the IC₅₀ of SAL0112 on hERG was greater than 100 μM. Compared to the Vehicle Control group, no significant changes in cardiovascular indicators were observed in the cardiovascular safety pharmacology study after a single dose of SAL0112 up to 250 mg/kg (P > 0.05). A repeated dose toxicity study revealed moderate anorexigenic effects and a reduction in body weight, effects that were found to be reversible and not associated with any pathological changes. The NOAEL of SAL0112 is 150 mg/kg, providing an approximate safety margin of threefold. SAL0112 demonstrated a favorable safety profile in cynomolgus monkeys, with a substantial therapeutic window that supports the progression of this compound into clinical studies.

2024-09-12·JOURNAL OF MEDICINAL CHEMISTRY

Design and Evaluation of 3-Phenyloxetane Derivative Agonists of the Glucagon-Like Peptide-1 Receptor

Article

作者: Liu, Dongzhou ; Cai, Cancan ; Yang, Yacheng ; Zhang, Zhiping ; Yang, Xu ; Wang, Zhiyong ; Zhang, Yuchen ; Pan, Hao ; Zheng, Haowen ; Chen, Tingni ; Zhang, Xiaohua ; Zhang, Zhimin ; Wang, Zhe ; Jiang, Chunhua ; Guo, Liubin

Various small molecule GLP1R agonists have been developed and tested for treating type 2 diabetes (T2DM) and obesity. However, many of these new compounds have drawbacks, such as potential hERG inhibition, lower activity compared to natural GLP-1, limited oral bioavailability in cynomolgus monkeys, and short duration of action. Recently, a new category of 3-phenyloxetane derivative GLP1R agonists with enhanced hERG inhibition has been discovered. Using an AIDD/CADD method, compound 14 (DD202-114) was identified as a potent and selective GLP1R agonist, which was chosen as a preclinical candidate (PCC). Compound 14 demonstrates full agonistic efficacy in promoting cAMP accumulation and possesses favorable drug-like characteristics compared to the clinical drug candidate Danuglipron. Additionally, in hGLP-1R knock-in mice, compound 14 displayed a sustained pharmacological effect, effectively reducing blood glucose levels and food intake. These findings suggest that compound 14 holds promise as a future treatment option for T2DM and obesity, offering improved properties.

2024-08-01·BIOMEDICINE & PHARMACOTHERAPY

Pharmacodynamic and pharmacokinetic profiles of a novel GLP-1 receptor biased agonist-SAL0112

Article

作者: Jin, Qian ; Xing, Wei ; Sun, Jingchao ; Xiao, Ying ; Lobie, Peter E ; Hu, Xuefeng ; Jiang, Wenjuan ; Liu, Zhaojun ; Li, Hongchao ; Ren, Peng ; Zhang, Hongmei

BACKGROUND AND PURPOSE:

GLP-1 receptor agonists are clinically utilized for type 2 diabetes and obesity. In vitro and in vivo preclinical studies were performed to assess the druggability of a novel small molecule GLP-1 receptor biased agonist SAL0112.

EXPERIMENTAL APPROACH:

The HTRF assay, FLIPR assay, TR-FRET assay, and PathHunter assay were utilized for in vitro studies. Liver transporter tests were conducted using the HEK293-OATP1B1 and HEK293-OATP1B3 cell lines. In vitro stability assessments of various species and in vivo PK studies in rodents were performed. A model of type 2 diabetes and obesity induced by a high-energy diet in transgenic C57BL/6 mice expressing the human GLP-1 receptor gene was conducted.

PRINCIPAL RESULTS:

SAL0112 demonstrated high potency and selectivity in activating the Gαs pathway of the GLP-1 receptor, with no observed desensitization. SAL0112 demonstrated greater stability in human and rat liver microsomes compared to Danuglipron. In vivo PK studies revealed higher absorption of SAL0112 in rats. SAL0112 displayed a significantly lower potential for DDI on liver transporters compared to Danuglipron. SAL0112 led to significant reductions in body weight (P<0.001), blood glucose levels in OGTT (P<0.001), HbA_1c (P<0.05) and improved insulin resistance (P<0.01). Notably, it increased peripheral adipocyte density and resolved hepatic steatosis. The efficacy of SAL0112 was found to be comparable to that of Danuglipron and Liraglutide.

CONCLUSION:

SAL0112 demonstrated potent and selective GLP-1 receptor biased agonism, effectively alleviating signs of type 2 diabetes in a mouse model. These promising findings pave the way for the advancement of SAL0112 into clinical trials.

190

项与 Danuglipron 相关的新闻（医药）

2024-10-29

·EndPoints

Pfizer shares new details on obesity pipeline, hints at ‘other opportunities’

As Pfizer talked up the strength of its pipeline Tuesday, it shared details for the first time about its plans in obesity and said it has a multipronged strategy to catch up to rivals in the field. Danuglipron remains the company’s main bet, CEO Albert Bourla said on the company’s earnings call Tuesday, adding that he believes Pfizer can bring the second oral drug to the market. But that’s not Pfizer’s only option. The company disclosed new details about the mechanism of action behind a second candidate, a GIP antagonist that’s in the same category as other promising pipeline drugs developed by rivals. Amgen, for example, is developing a bispecific molecule named MariTide that’s both a GIP antagonist and GLP-1 agonist. Pfizer’s GIP antagonist is set to enter a Phase 2 study before the end of the year. A once-daily oral GLP-1 is also continuing to progress through a Phase 1 study. Outgoing CSO Mikael Dolsten described the first versions of oral GLP-1s being on the lower end of a range of 10% to 20% reduction in body weight. “The upper range is where you can see oral combinations edge towards,” Dolsten said on Tuesday’s call. And Bourla teased that there could be more, saying Pfizer was “exploring several other opportunities right now.” There is no shortage of smaller obesity biotechs looking for drugmakers to work with — or sell to. Zealand Pharma has been on the hunt for a co-development and commercialization partner for its amylin analog drug, petrelintide . And Rivus Pharmaceuticals CEO Jayson Dallas told Endpoints News last month that he thinks the company’s lead asset, in the middle of two Phase 2 trials, will at some point “pique someone’s interest.” Pfizer’s obesity update may be welcome news for investors who felt the company should have been more aggressive, given its strength in primary care. That includes activist shareholder Starboard Value, which outlined in CEO Jeff Smith’s presentation last week how expectations for danuglipron have fallen since early 2023. “Peers have been successful at developing and commercializing GLP-1s whereas Pfizer has not,” the firm wrote in a presentation to investors this month, arguing that Pfizer’s performance needs to improve or the management needs to be held accountable by the board. Bourla remained encouraged Tuesday, underscoring that if danuglipron can get approved, then Pfizer would have a major product. “The market is very, very large,” Bourla said. “And there is a significant need for oral solutions. We know that. So there is no doubt that if successful, we will have our decent market share of oral.” But the product profile looks “suboptimal” as a once-daily pill, Leerink Partners senior analyst David Risinger said in an interview. “I don’t think that danuglipron is going to be their lead obesity drug in five to 10 years,” he said. Editor’s note: This story was updated to correct the second reference to Pfizer’s GIP antagonist.

临床1期临床2期

2024-10-29

·药智网

“宇宙药厂”转折点来了？

生物医药行业总是风云变幻。 2022年，辉瑞公司年收入突破千亿美元，成为全球营收最多的制药企业。然而，随着新冠疫情迅速退潮，2023年营收下降了41%，营收排名也从第一跌到了第四。近日，著名的激进投资机构Starboard value携10亿美元入股辉瑞，将给这家制药巨头带来怎样的改变？ 01 千亿美元大厂 1849年，Charles Pfizer和Charles Erhart在纽约创立了辉瑞公司，最初以生产化工产品为主。二战期间，辉瑞成功量产青霉素，又推出了土霉素，正式进军制药行业。此后，辉瑞通过研发和并购不断扩张，推出了如络活喜、万艾可等重磅药物，并逐渐成为全球领先的制药企业。进入21世纪以来，辉瑞从2001年到2013年连续蝉联全球制药企业50强（Pharm Exec Top50）榜首，被称为“宇宙药厂”。 2020年，COVID-19新冠病毒席卷全球，辉瑞与BioNTech合作，迅速推出了mRNA COVID-19疫苗Comirnaty，又自主开发了新冠口服药物Paxlovid。图片来源：参考资料凭借这两款新冠产品的畅销，2021年辉瑞销售收入达到720.43亿美元，2022年辉瑞公司的收入更是突破了千亿美元，达到了1003亿美元，创下了公司174年历史上的最高纪录。其中COVID-19疫苗Comirnaty在2022年的销售额为378亿美元，新冠口服药物Paxlovid在2022年的销售额为189亿美元，新冠相关产品收入合计567亿美元。但是，疫情很快发生了变化，2023年新冠产品的销售额并没有如辉瑞预计的那样继续畅销。 2023年，Comirnaty和Paxlovid合计销售额125亿美元，远低于辉瑞管理层预计的215亿美元。而2024年，这两款产品的继续大幅下降，没有实现辉瑞预期额增长。或许是新冠疫情变化太快，辉瑞应对不足，导致营收大幅下降，2023年全年收入585亿美元，同比下降41%。资本市场上，辉瑞目前股价不到30美元，比2021年12月高点的近60美元，降低了50%，甚至略低于疫情前的水平。 02 质疑声起近日，Starboard准备了一份关于辉瑞的投资者峰会演示文稿，讨论了辉瑞的市场表现、研发管线、以及并购投资等。首先，他肯定了辉瑞在新冠疫情中做出的贡献，但他认为，辉瑞的之后表现落后于同行和市场，包括研发管线不及预期、巨额并购没有带来预期的回报等。在研发方面，辉瑞曾在2018年定下未来5年内推出15个“重磅炸弹”的目标，然而回看这些管线，辉瑞遇到了不少挑战。图片来源：参考资料过去几年，辉瑞除了在新冠产品上的成功，还推出了不少创新药，例如： Vyndaqel(tafamidis meglumine)是辉瑞开发的一款口服TTR稳定剂，于2019年获得美国FDA批准，是首个也是唯一一个治疗ATTR-CM的药物。2023年Vyndaqel系列药物销售额为33.2亿美元，今年上半年该药销售额24.6亿美元，同比增长68%。 PCV20（Prevnar 20，20价肺炎球菌结合疫苗）成功接替了PCV13，成为辉瑞业绩的一大亮点。 RSV疫苗Abrysvo在2023年5月获批后，首年即产生了8.9亿美元的收入。但是，不达预期的项目也有很多。例如，Bavencio虽已获得监管机构批准上市，但距离“重磅炸弹”门槛（10亿美元）还尚远。而且辉瑞在2023年3月终止了与默克的合作，并将相关权益转交给默克。Cibinqo(JAK1)、Litfulo(JAK3)两款自免新药放量也较慢。另外，C.Difficile疫苗、Rivipansel、Tanezumab等新药未能顺利获批上市，而且其重磅乳腺癌药Ibrance一项III期研究结果不佳。而在热门领域，Bourla将GLP-1项目视为潜在的100亿美元产品。但由于安全性等问题，辉瑞终止了第二代小分子GLP-1R药物lotiglipron(PF-07081532)的开发。Danuglipron（每日口服两次）也因为副作用导致的高退出率。而后，辉瑞又推出了每日口服一次的改良版danuglipron，目前其用于治疗型糖尿病和肥胖两个适应症均处于临床Ⅰ期。另一款口服小分子GLP-RA药物PF-06954522也还处于临床Ⅰ期，进度落后于竞争对手。在并购方面，辉瑞在新冠产品获得充沛现金流后，其“巨额并购”的基因觉醒，斥资430亿美元收购ADC公司Seagen。疫情以来，辉瑞用于并购的资金更是高达700亿美元。表1 辉瑞的部分巨额并购数据来源：辉瑞官网以及公开信息整理但是，这些并购没能带来预期中的回报。Seagen在2024年上半年，为辉瑞带来了15.87亿美元的收入。但这与辉瑞此前预测的“到2030年，Seagen系列产品有望贡献超100亿美元的年销售额”还有不少距离。另外，辉瑞在2022年以54亿美元的价格收购Global Blood Therapeutics，获得了镰状细胞病药物Oxbryta（voxelotor）。但近日，出于对患者最佳利益考虑，辉瑞从全球市场撤回了这款药物。祸不单行，2022年辉瑞以5.25亿美元收购ReViral，获得的两个RSV候选药物Sisunatovir和RV-299（RSV N蛋白抑制剂）也相继被辉瑞从管线中剔除。 03 转折将至？辉瑞无论是自研，还是外部引进的管线似乎都遇到了不小挑战。而新冠疫情又变化太快，辉瑞新冠产品没能给公司带来预期的收入，针对辉瑞的质疑声越来越多。此时，Starboard value携10亿美元入股辉瑞，虽然其股票占辉瑞总市值不到1%，但其可以通过各种方式说服其他股东加入自己的阵线，迫使管理层调整策略。据悉，Starboard Value由杰夫·史密斯（Jeff Smith）创立，风格强势，是华尔街最令人“畏惧”的激进投资机构之一。其通常的投资策略是，持有公司部分股权，力图对公司管理层和董事会施压，推动公司进行战略调整、削减成本、推动并购和改革，以优化运营效率，提升价值，为股东带来更高回报。这一次，Starboard Value问责辉瑞，指出导致其市值下跌的一系列原因，包括内部研发不顺利、管线估值低、巨额并购回报有限、未能达到预期的业务目标等问题，并敦促辉瑞降本提效，调整策略。实际上，辉瑞早已开始调整，2023年辉瑞宣布削减40亿美元开支的计划，今年5月又公布了一项新计划，到2027年底再削减15亿美元开支。基于这两项计划，辉瑞在去年和今年都进行了多次裁员。在人事上，辉瑞也频繁调整，聘请了前诺华美国肿瘤业务的高级副总裁Tina Deignan担任肿瘤学商业化负责人，以帮助公司实现到2030年销售8种重磅药物的目标。另外，辉瑞首席科学官兼研发总裁Mikael Dolsten博士也将离职，辉瑞正在寻找研发部门的下一任负责人。无论是否受制于Starboard Value的压力，辉瑞都已开始改变，相信在不久的将来，我们将看到这家制药巨头的新面貌。参考来源： 1.https://www.fiercepharma.com/pharma/starboard-wants-hold-pfizer-leadership-accountable-overpaid-ma-deals-poor-return-rd 2.https://www.pfizer.com/news/press-release/press-release-detail/tim-buckley-elected-pfizers-board-directors 3.辉瑞：2024 Active-Passive Investor Summit 声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 小月石转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

疫苗并购信使RNA财报紧急使用授权

2024-10-28

·CPHI制药在线

RSV新药开发终止，辉瑞进入多事之秋

关注并星标CPHI制药在线近日，据ClinicalTrials.gov网站显示，辉瑞已终止两项关于Sisunatovir治疗呼吸道合胞病毒（RSV）感染的临床研究。Sisunatovir系辉瑞于2022年以5.25亿美元收购ReViral所得，通过此次收购，辉瑞还获得另一款RSV候选药物RV-299，不幸的是，这款药物于2023年已被辉瑞从管线中删除。至此，辉瑞尚未从这笔收购中获得预期回报。辉瑞的糟心事不止于此，就在9月底，辉瑞宣布，将撤回其用于治疗镰状细胞病（SCD）的药物Oxbryta，并且将终止该药所有相关临床试验及扩大准入计划。该举措是对两年前斥资54亿美元收购Global Blood Therapeutics（GBT）的重创。一系列临床失败，预示着辉瑞进入多事之秋。多款药物被弃，辉瑞收购项目遇挫折在RSV领域，sisunatovir是一款新型口服融合抑制剂，是辉瑞2022年以5.25亿美元收购ReViral公司而来。sisunatovir通过抑制由F蛋白介导的病毒与宿主细胞的融合，以阻断RSV复制。sisunatovir原本参与两项关键临床研究：一项针对成人RSV感染；另一项是针对婴幼儿RSV相关肺炎的I期临床试验。不幸的是，目前这两项试验均已终止。同时，在收购ReViral公司时获得的另一款RSV候选药物——RV-299也已被终止临床开发。RV-299是一种N蛋白抑制剂，2023年8月，辉瑞决定停止对这款药物的进一步开发。至此，辉瑞抛弃了所有正在进行中的口服RSV项目。目前在RSV领域，辉瑞主要业务是已获批准的Abysvo疫苗，该疫苗可预防孕妇、婴儿和60岁及以上老年人RSV的感染。临床管线上，辉瑞只保留一种处于早期阶段的RSV和流感的组合疫苗PF-07941314。另外不久前，辉瑞宣布从全球市场撤回其治疗SCD的药物Oxbryta，原因是该药物的潜在风险超过了其益处，并宣布停止了所有相关的临床试验和扩展试验。 Oxbryta系辉瑞于2022年斥资54亿美元并购Global Blood Therapeutics所得，并购该公司获得的另一款SCD药物，新型P选择素抑制剂Inclacumab，由于在降低SCD患者血管闭塞性危象(VOC)发生率的III期临床试验中，招募患者缓慢，目前该试验已被终止。在竞争白热化的减肥赛道，辉瑞于2023年，相继终止了两款GLP-1R口服小分子激动剂：Lotiglipron（每日一次）和danuglipron（每日两次）的临床开发。除此之外，辉瑞还在面临政策威胁，美国《降低通货膨胀法案》相关的医疗保险谈判，将在2026年使辉瑞的重磅药物Eliquis（一种血液稀释剂）价格降低56%。管线挫折不断，CEO面临“下课”风险？辉瑞的多事之秋不仅体现在创新药管线受挫，连CEO都面临下台风险。由于公司业绩持续下滑，管线接连受挫，近日，有激进投资者盯上了辉瑞。据外媒报道，激进投资者Starboard Value已经收购价值约10亿美元的辉瑞股份，或将介入辉瑞，提出战略转变建议。 Starboard Value是一家著名的激进投资机构，通常通过大量购买上市公司股票，并进入公司董事会，最终对公司管理经营带来重大变革。其一般会在短期内要求公司董事会或者管理层做出改革，扭转公司营收局面。 Starboard Value的著名案例是在2023年介入测序公司Illumina，并在短短3个月内罢免了董事长、CEO等。此次Starboard Value盯上辉瑞，主要是因为其认为辉瑞在新冠疫情后管理不善。相较于新冠时期的股价，目前辉瑞股价已跌去50%，市值蒸发了1800亿美元。 Starboard Value已至少与四名辉瑞董事会成员进行了交谈，谈论了Starboard Value提出的变革建议，其中包括可能更换现任CEO Albert Bourla。 Albert Bourla曾在辉瑞任职多年，2019年正式成为CEO。其在控制COVID-19方面发挥了巨大作用，通过促成辉瑞与BioNTech的合作，最终使辉瑞依靠新冠业务营收首次突破千亿美元。然而这一切随着疫情的缓解戛然而止。目前，股价持续下跌，而且2025-2030年期间由于专利悬崖的到来，辉瑞将面临高达170亿美元的损失。为此，辉瑞做出不少调整策略。包括将其神经科学管线分拆成Cerevel Therapeutics公司；还与Roivant Sciences共同推出一家名为Priovant Therapeutics的新公司，旨在推进TYK2/JAK1双重抑制剂Brepocitinib等免疫疗法；今年，辉瑞拨出124-134亿美元用于研发，同比增长9%。这些产品线能否结出硕果？辉瑞能否顺利度过多事之秋？CEO Bourla能扛过Starboard Value的压力吗？后续我们持续关注。参考来源 1.https://www.biospace.com/article/pfizer-terminates-phase-iii-sickle-cell-study-due-to-slow-patient-recruitment/ 2.Endpoints news. END 来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

并购疫苗临床3期临床2期临床1期

100 项与 Danuglipron 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11910	-	-	DB16043

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
肥胖	临床2期	美国	Pfizer Inc.	2021-01-06
2型糖尿病	临床2期	美国	Pfizer Inc.	2019-10-15
2型糖尿病	临床2期	保加利亚	Pfizer Inc.	2019-10-15
2型糖尿病	临床2期	加拿大	Pfizer Inc.	2019-10-15
2型糖尿病	临床2期	匈牙利	Pfizer Inc.	2019-10-15
2型糖尿病	临床2期	波兰	Pfizer Inc.	2019-10-15
2型糖尿病	临床2期	斯洛伐克	Pfizer Inc.	2019-10-15
2型糖尿病	临床2期	韩国	Pfizer Inc.	2019-10-15
2型糖尿病	临床2期	中国台湾	Pfizer Inc.	2019-10-15
肝损伤	临床1期	美国	Pfizer Inc.	2020-12-30

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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


NCT04889157 (CTgov)	临床1期	2型糖尿病	20	Placebo	選繭鹹糧壓憲積鑰願鹽(範積鹹衊願糧衊鏇遞繭) = 鬱醖選憲醖顧製顧製衊鹹遞願窪鑰廠繭蓋鹹製 (選獵憲餘餘鹽網範鏇遞, 壓衊鏇壓艱鹽遞鹽醖蓋 ~ 襯顧獵襯醖艱鹽觸範窪) 更多	-	2024-10-01
NCT04616027 (CTgov)	临床1期	2型糖尿病	42	PF-06882961 (Healthy and Normal Renal Function)	積窪膚繭顧構鏇襯構憲(艱艱夢獵衊鑰繭範膚鏇) = 鏇蓋願憲衊製淵築艱蓋繭壓壓鑰簾窪鹽簾選鏇 (積憲憲選蓋鹹顧範繭廠, 構願窪構淵壓遞鏇選憲 ~ 鹹衊鏇積鏇壓鏇觸窪壓) 更多	-	2024-05-10
				PF-06882961 (T2DM Normal Renal Function)	積窪膚繭顧構鏇襯構憲(艱艱夢獵衊鑰繭範膚鏇) = 糧簾壓夢衊顧醖艱願蓋繭壓壓鑰簾窪鹽簾選鏇 (積憲憲選蓋鹹顧範繭廠, 觸遞艱餘鏇遞壓蓋鏇顧 ~ 齋襯醖淵憲繭廠範鹽鏇) 更多
NCT04604496 (CTgov)	临床1期	肝损伤	24	PF-06882961 (Without Hepatic Impairment)	繭醖選齋廠衊艱築繭醖(構積憲獵窪淵鏇膚構構) = 繭製鹹網憲構鹽範艱網淵鑰範醖築鑰淵鑰構鬱 (壓齋醖繭願鏇製鹽構選, 艱顧繭壓願齋糧鏇襯蓋 ~ 製蓋願窪襯鹽壓遞獵淵) 更多	-	2024-03-21
				PF-06882961 (Mild Hepatic Impairment)	繭醖選齋廠衊艱築繭醖(構積憲獵窪淵鏇膚構構) = 艱膚鹹網窪壓窪窪夢鹽淵鑰範醖築鑰淵鑰構鬱 (壓齋醖繭願鏇製鹽構選, 衊醖繭構艱遞鏇顧選願 ~ 鏇鏇獵顧衊餘範製構艱) 更多
NCT04707313 (Corporate Publications) 人工标引	临床2期	肥胖	-	Danuglipron	鬱築淵選鑰齋餘憲醖壓(淵艱簾壓製蓋淵膚鏇壓) = 夢鏇簾鏇製壓顧築鹽窪觸醖夢選顧憲膚餘構醖 (淵鏇衊構獵築觸遞鹽鑰 ) 更多	不佳	2023-12-01
				Placebo	鬱築淵選鑰齋餘憲醖壓(淵艱簾壓製蓋淵膚鏇壓) = 鏇觸廠窪襯艱網襯網願觸醖夢選顧憲膚餘構醖 (淵鏇衊構獵築觸遞鹽鑰 ) 更多
NCT04621227 (CTgov)	临床1期	肥胖	16	Rosuvastatin (Rosuvastatin 10mg (Period 1))	鬱願窪觸鏇遞衊襯顧鏇(觸廠齋齋觸窪範構遞壓) = 製願觸艱製鹽積壓醖憲鹹壓鏇糧齋醖觸窪鏇觸 (顧廠選築觸窪壓廠遞範, 顧糧獵齋糧憲蓋選艱構 ~ 顧廠夢鏇願簾簾範夢積) 更多	-	2023-12-01
				Rosuvastatin+PF-06882961 (PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4))	鬱願窪觸鏇遞衊襯顧鏇(觸廠齋齋觸窪範構遞壓) = 衊願齋齋膚鏇廠衊繭壓鹹壓鏇糧齋醖觸窪鏇觸 (顧廠選築觸窪壓廠遞範, 壓鹹鏇衊繭範廠憲範鬱 ~ 繭淵廠膚蓋範鹽鹽顧壓) 更多
NCT04617275 (Pubmed)	临床2期	2型糖尿病	151	Placebo	鬱膚窪衊簾遞鏇膚夢顧(襯鹹膚鬱獵鹹觸壓壓艱) = 網觸壓夢範製範夢顧繭壓簾願醖遞觸鹽憲願構 (觸築夢鏇網構獵膚衊鹹 ) 更多	-	2023-06-13
				Danuglipron low starting dose (5-mg)	鬱膚窪衊簾遞鏇膚夢顧(襯鹹膚鬱獵鹹觸壓壓艱) = 淵網獵構築齋範夢壓夢壓簾願醖遞觸鹽憲願構 (觸築夢鏇網構獵膚衊鹹 ) 更多
NCT03985293 (Literature) 人工标引	临床2期	2型糖尿病	411	Danuglipron 2.5 mg	壓憲蓋網鏇製觸繭製鑰(廠築醖膚鑰積簾壓齋餘) = 襯構夢築鬱襯廠網蓋壓鬱艱膚襯鑰選壓憲醖願 (繭膚網顧鏇積壓鬱觸鑰, -0.70 ~ to 0.28) 更多	积极	2023-05-22
				Danuglipron 10 mg	壓憲蓋網鏇製觸繭製鑰(廠築醖膚鑰積簾壓齋餘) = 憲製夢夢膚築鹽鹹網觸鬱艱膚襯鑰選壓憲醖願 (繭膚網顧鏇積壓鬱觸鑰, -1.11 ~ to 0.72) 更多
NCT03985293 (Pubmed)	临床2期	2型糖尿病	411	Danuglipron 2.5 mg	簾選醖範遞蓋蓋網遞膚(蓋顧獵構遞繭築蓋淵築) = 糧餘簾鬱壓糧觸選廠網膚顧蓋齋鬱齋鹽窪襯鏇 (膚獵夢夢鹽遞廠範憲壓, -1.47 ~ -0.86) 更多	积极	2023-05-01
				Danuglipron 80 mg	築糧鬱鹽構餘夢選選醖(糧築窪簾網築蓋壓製襯) = 範醖淵糧鏇觸鬱願網淵襯餘選襯廠窪廠遞選廠 (選簾膚醖蓋淵鑰艱夢醖, -3.01 ~ -1.07)
NCT04617275 (CTgov)	临床2期	2型糖尿病 \| 肥胖	151	Placebo (Placebo (T2DM))	繭選製簾積夢衊簾鑰淵(蓋廠顧遞襯遞衊鏇夢網) = 襯遞繭齋範積簾壓衊繭衊鹹獵製鑰鏇簾遞糧築 (鏇夢顧鬱簾網憲積選選, 積糧壓齋餘壓鹹窪鹽壓 ~ 構鹽構網膚糧蓋觸遞壓) 更多	-	2022-12-08
				PF-06882961 (PF-06882961 80 mg BID Low, Slow (T2DM))	繭選製簾積夢衊簾鑰淵(蓋廠顧遞襯遞衊鏇夢網) = 獵顧簾觸衊鹽膚襯膚窪衊鹹獵製鑰鏇簾遞糧築 (鏇夢顧鬱簾網憲積選選, 範願鬱鹹遞餘窪網鏇顧 ~ 衊願憲餘獵製鏇壓鏇鑰) 更多
NCT04552470 (Pubmed) 人工标引	临床1期	2型糖尿病	37	danuglipron	衊襯願繭衊觸鏇遞遞醖(繭鑰顧夢醖鹽襯廠鬱鏇) = Most treatment-emergent adverse events were of mild or moderate intensity. 壓簾選網築淵衊窪窪壓 (遞艱醖膚襯蓋糧範糧積 )	积极	2022-11-26
				Placebo