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, 21 weeks (about 5 months) for Cohort 3 and 20 weeks (about 5 months) for Cohort 4.

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

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.

192

项与 Danuglipron 相关的新闻（医药）

2024-11-20

·EndPoints

Pfizer partners with two more Flagship biotechs on obesity, cancer

Pfizer is enlisting another Flagship startup to help it create new obesity medicines. After June’s ProFound Therapeutics tie-up , Pfizer will work with the incubator’s Ampersand Biomedicines in the hunt for new biologics for obesity. The New York pharmaceutical company is also tapping into Flagship-founded Montai Therapeutics to find new small molecules for potentially treating lung cancer, the companies said Wednesday morning. The two pacts are part of Pfizer’s broader alliance with the Cambridge, MA-based Flagship, which recently reeled in about $3.6 billion in new funds as pharma partnerships become a “ bigger and bigger deal .” Pfizer has had an uneven few years in obesity, particularly with its danuglipron program . Last month, it revealed more details about its other early-stage bets: a GIP antagonist and a once-daily oral GLP-1. Ampersand hopes to help Pfizer create obesity treatments that go to a specific site in the body, rather than hitting healthy tissues or cells, so as to avoid side effects — like muscle loss and gastrointestinal concerns — and to make the drugs more potent. The startup, which emerged with $50 million in March 2023, uses computational methods to find “addresses” for drugs to go to and then creates an “actuator” to carry out the therapeutic function, Flagship general partner Avak Kahvejian told Endpoints News last year. In January, it bought antibody discovery tech startup AbCheck, an Affimed subsidiary, for $6 million. “We have addresses in virtually every tissue in the body, so you could think about virtually any disease,” CEO Jason Gardner said in an interview. Ampersand will likely make multiple other industry collaborations, he said, and it could form more tie-ups around obesity. It’s early days with the Pfizer partnership, and Gardner declined to disclose the specific pathway tissue that they’re looking at. Flagship’s work in obesity has also attracted the attention of Novo Nordisk. Its companies Metaphore Biotechnologies and Omega Therapeutics have both formed partnerships with the Danish drugmaker. In cancer, Pfizer’s new partnership with Montai will look at mechanisms that lead to lung cancer cell growth and find new small molecules that can potentially be turned into therapies. Pfizer has made oncology a core focus following its $43 billion Seagen acquisition last year. Montai emerged with $50 million in December 2022 and a high-profile CEO, Margo Georgiadis, who previously led Google’s Americas division and steered Ancestry.com to a nearly $5 billion exit to Blackstone. The startup scours through molecules already consumed by humans via foods, supplements and herbal medicines. Its computational tools have brought together nearly 200 million so-called “Anthromolecules” and their derivatives, Georgiadis said. The company’s name means “climbing mountains with AI,” she said. Georgiadis said in an interview that the company is trying to “create the first machine learning that enables us to decode that language of chemistry and how it connects to our biology.” “By doing that, it enables us to take advantage of this unbelievably rich and diverse chemistry set that pharma had kind of put to the side,” she said. “It’s how drug development started. It’s a super-proven source of drugs, but it was perceived as complex, hard to make, the challenges with polypharmacology.” Montai was working on a small molecule agonist for an undisclosed pathway in inflammation and immunology when Pfizer realized an antagonist of that pathway could be applied in lung cancer, Georgiadis said. The 65-employee company has created an internal pipeline of nine I&I therapies that are transcription factors and biologic replacements in dermatology, gastrointestinal and respiratory diseases, she said. The company is “developing partnerships” with more companies, Georgiadis said, as Montai’s work applies across immunology, oncology, neuro-inflammation and other areas.

并购

2024-11-13

·CPHI制药在线

没有买卖就没法洗牌，减肥并购中的买家卖家

关注并星标CPHI制药在线减肥药开发是医药行业目前最大的热点之一，甚至有分析机构预测，减肥药市场未来的规模将发展到2000亿美元的水平，几乎可以和目前的肿瘤学产品比肩，因此众多生物医药和科技公司都渴望跻身这个拥有巨大开发潜力的市场之中。诺和诺德的减肥药Wegovy今年第三季度获得了25亿美元的销售业绩，预计明年将拿下130亿美元的全球销售额，并一举跻身重磅炸弹前十名的榜单。在这样一片大好的局面下，即便诺和的Wegovy和礼来的Zepbound把持了目前减肥药市场的绝大部分市场，但仍然有一干减肥药开发商抱着“野芳虽晚不须嗟”的信念在开发减肥药的道路上大干快上。而在另一块平行战场上，减肥药项目和企业的收购竞争也在经历激烈的明争暗斗。最新的大热收购目标是12年前创立的总部位于加州圣迭戈的Viking Therapeutics。 Viking Therapeutics 的口服多肽减肥药 VK2735 在 1 期临床试验中表现出较高的有效性和安全性，吸引了行业的广泛关注。VK2735 是一种双重 GLP-1/GIP 受体激动剂。在其I期研究中，受试者的体重显著下降，并且VK2735表现出了良好的安全性和耐受性。在 100 mg 的最高剂量组中，VK2735 实现了安慰剂调整后28天6.8%的减重率，这个数据令行业侧目。众多分析师在看好VK2735未来的同时，也纷纷认为Viking Therapeutics将成为制药业巨头收购的下一个热点。 Viking没有稳定的资金注入，独自完成VK2735上市的目标稍显艰巨，尤其是考虑到口服版本的研究仍然处于I期，皮下注射的临床也只是II期，因此需要大量资金的注入才有可能实现产品的上市。之前Viking似乎一直处于“待价而沽”的状态，等待的似乎就是关键里程碑的实现。而如今I期口服制剂数据的出炉似乎就是最好的时机，因此Viking的收购成为了越来越接近现实的交易。包括辉瑞和阿斯利康在内的多家大型公司在内，他们收购减肥药资产或公司的意愿早已不是秘密。阿斯利康从中国Eccogene Inc.（诚意生物）收购的GLP-1减肥药资产AZD5004恰好也是一款口服制剂，但不同于VK2735，AZD5004是一款小分子药物。阿斯利康也在近期的ObesityWeek 2024会议上公布了AZD5004的I期数据，显示出5.8%的四周减重率。因此阿斯利康继续收购口服减肥药资产的意愿可能没有那么强烈。而辉瑞在终止了其小分子GLP-1口服减肥药资产lotiglipron之后，又终止了另一款口服小分子减肥药danuglipron每日两剂的临床研究，目前只剩下danuglipron的每日一剂肥胖症项目，因此收购意图可能更为强烈。除了Viking Therapeutics之外，作为“收购靶点”的公司还包括下列减肥候选药资产拥有者： Structure Therapeutics • 总部：美国加州南旧金山 • 成立时间：2021年 • 市值（2024年11月6日值，下同）：22亿美元 • 主要减肥药资产：Aleniglipron（又名GSBR-1290口服GLP-1受体激动剂），II期数据公布 • 收购看点：Aleniglipron的II期数据与礼来小分子口服GLP-1减肥候药orforglipron可比（12周安慰剂调整后减重率6.2%），但停药率可能较低。小分子口服药具有明显的成本优势，因此代表了减肥药开发的下一波热点。那些拥有口服减肥药资产，且已经产生了不错临床中后期数据的中小公司必然会成为收购重点。 • 收购阻碍：开发位置看上去至少落后orforglipron一年。在机制相同、疗效相近、模态一样的情况下，时间线决定了未来的市场地位和如今的收购价值。 Altimmune Inc. • 总部：美国马里兰州Gaithersburg • 成立时间：1997年 • 市值：5.1亿美元 • 主要减肥药资产：Pemvidutide（每周注射一次多肽GLP-1/胰高血糖素双受体共激动剂），III期研究中。 • 收购看点：长期减重率略优于Wegovy。2.4 mg pemvidutide 48周减重率15.6%。Pemvidutide同时对代谢障碍相关脂肪型肝炎（MASH）进行临床研究。 • 收购障碍：20% 的停药率可能是一个限制因素，但随着患者进入第 3 阶段，允许剂量减少，这应该会对耐受性所有帮助。 Zealand Pharma • 总部：丹麦哥本哈根 • 成立时间：1999年 • 市值：87.6亿美元 • 主要减肥药资产：Survodutide（每周注射一次的多肽GLP-1/胰高血糖素双受体共激动剂），III期临床进行中，授权勃林格殷格翰开发；Dapiglutide（GLP-1/GLP-2共激动剂），II期进行中；Petrelintide（胰淀素类似物），II期进行中。 • 收购看点：Zealand Pharma将根据survodutide全球销售额获取10%左右的版税；项目已经进入III期，有望成为首批Wegovy和Zepbound的挑战者；46周19%减重率；针对MASH开发获得FDA突破性疗法头衔；同时拥有新颖机制的GLP-1/GLP-2双受体共激动剂中期资产，以及胰淀素激动剂中期资产petrelintide。Zealand Pharma在不久前的ObesityWeek 2024会议中公布了petrelintide的I期数据，引发了广泛关注。多次递增剂量 I 期试验数据显示，在16周每周注射一次（剂量分别为 2.4 mg, 4.8 mg 和 9.0 mg）后，平均体重减轻 4.8%、8.6% 和 8.3%，而合并安慰剂组减轻 1.7%。这显示了petrelintide不仅在机制上能够填补目前减肥药的空白，在实际疗效上可能也具备了未来与semaglutide和tirzepatide分庭抗礼的潜力。美国银行分析师表示，他们预计petrelintide将主要用于 GLP-1 不耐受或失败市场（约占 20% 的患者），并预计其年销售额将达到 80 亿美元的峰值。 • 收购障碍：自身被收购意愿可能较低，但Zealand Pharma已经表达出了正在寻找共同开发petrelintide的合作伙伴的动态。与授权survodutide的模式不同，Zealand Pharma将参与petrelintide的开发与商业化的整个过程。Zealand Pharma的CEO表示，目前已就petrelintide的潜在合作开发与前十大制药企业中的一家产生了关联，但不肯透露更多的消息。 Fractyl Health • 总部：美国马萨诸塞州Burlington • 成立时间：2010年 • 市值：1.1亿美元 • 主要减肥药资产：Revita（一种门诊内窥镜手术，通过热液消融持久改变十二指肠功能障碍，从而恢复代谢健康。有证据表明，Revita 可能为肥胖和 2 型糖尿病患者提供持久的体重维持和改善血糖控制。针对接受 GLP-1 药物治疗体重至少减轻 15% 并希望停止使用 GLA-1 药物而不反弹的患者进行临床研究）；Rejuva （一种新型局部给药 AAV 基因疗法，目前处于临床前开发阶段，可改善胰岛功能。通过改变患者的胰腺胰岛细胞中的代谢激素反应，实现持久的体重减轻和 2 型糖尿病的长期缓解。） • 收购看点：提供长期体重管理的方案 • 收购障碍：特殊治疗后产生的不良反应潜在肥胖症资产和公司买家 • 默沙东（收购意愿：高）：默沙东的药王Keytruda将在2028年专利到期，默沙东对代谢类疾病表现出了高度兴趣，但缺乏GLP-1管线资产。 • 诺和诺德（收购意愿：高）：诺和诺德一直在通过资产购买的方式巩固自己在代谢疾病领域的领先地位。 • 辉瑞（收购意愿：中/高）：辉瑞一直在努力开发口服减肥药，但屡遭挫折。目前几乎硕果仅存的GLP-1小分子减肥候选药daniglupron的前景并不被看好，因此在此路不通的情况下，辉瑞可能选择外部资产的引入。 • 强生（收购意愿：中/高）：近期代谢疾病领域的挫折（Xarelto, Invokana, aprocitentan）大大刺激了强生通过收购外部资产的渴望。 • 礼来（收购意愿：高）：与诺和诺德的减肥药“军备竞赛”。 • 阿斯利康（收购意愿：中/高）：从中国Eccogene Inc.（诚意生物）收购的GLP-1减肥药资产AZD5004令阿斯利康在减肥药竞赛中处于了一个有利的位置。阿斯利康透露出减肥药与Farxiga设计联合疗法的强烈愿望。 • 勃林格殷格翰（收购意愿：高）：BI对于代谢疾病疗法开发具有很高兴趣，其survodutide是从Zealand Pharma获取授权的资产，因此拥有一款独立的减肥药资产对于BI有着强大的吸引力。 • 罗氏（收购意愿：中/高）：最近从Carmot收购GLP-1资产显示了罗氏对开发减肥药的兴趣。罗氏并不算充盈的减肥药管线昭示着可能会有更多的收购项目到来。 • 第一三共（收购意愿：中）：尽管代谢类疾病曾经是第一三共的开发重点，但其目前的核心资产是肿瘤学产品。 • 赛诺菲（收购意愿：中）：赛诺菲的开发中心已经转移到了炎症和免疫产品，但历史上对于代谢疾病的开发可能重燃赛诺菲进军肥胖症的热情。 • 诺华（收购意愿：中）：虽然拥有不少代谢疾病资产，但诺华的核心竞争力在于肿瘤学、免疫学和罕见疾病。 Ref. Malone, E. Top 10 Drugs Q2 2024: Mounjaro Comes Roaring In. Skyrizi Also Makes Its Debut. Scrip. 24. 10. 2024. Structure Therapeutics Reports Positive Topline Data from its Phase 2a Obesity Study and Capsule to Tablet PK Study for its Oral Non-Peptide Small Molecule GLP-1 Receptor Agonist GSBR-1290. Structure Press Release. 03. 06. 2024. Boehringer Ingelheim to advance survodutide into three global Phase III studies in obesity. BI Press Release. 17. 08. 2023. Obesity Drugs: The Next Wave of GLP-1 Competition. New drugs from public and private companies will challenge Novo and Lilly's dominance. Morningstar & PitchBook. Sept. 2024. END 【智药研习社线上研习会报名】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~

并购临床1期

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

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	窪製簾簾鏇餘築夢艱願(獵艱顧衊廠積壓艱遞網) = 夢齋願鬱選製築製顧襯糧範積醖糧壓範簾簾鏇 (夢廠夢構壓襯範艱遞簾, 膚製鏇艱築壓鏇鬱夢壓 ~ 繭憲製鹹淵醖製醖襯鑰) 更多	-	2024-10-01
NCT04616027 (CTgov)	临床1期	2型糖尿病	42	PF-06882961 (Healthy and Normal Renal Function)	選獵獵蓋廠壓積窪淵顧(壓醖淵齋衊憲衊遞壓選) = 鑰繭鑰選鬱網淵顧繭夢築糧餘顧衊餘窪鹹壓選 (範衊壓遞觸願築鏇夢鹽, 觸夢膚遞憲築廠餘蓋鏇 ~ 淵遞鏇鏇襯顧襯齋獵願) 更多	-	2024-05-10
				PF-06882961 (T2DM Normal Renal Function)	選獵獵蓋廠壓積窪淵顧(壓醖淵齋衊憲衊遞壓選) = 鑰膚積積廠顧鹽鹹鹽壓築糧餘顧衊餘窪鹹壓選 (範衊壓遞觸願築鏇夢鹽, 積窪齋選構積淵襯廠衊 ~ 觸淵鏇鹹範網鏇淵壓艱) 更多
NCT04604496 (CTgov)	临床1期	肝损伤	24	PF-06882961 (Without Hepatic Impairment)	獵醖糧膚膚範醖蓋鬱糧(憲壓襯壓簾繭醖網積淵) = 衊廠窪鏇夢廠築蓋遞遞衊鑰憲餘獵襯構淵餘鑰 (願遞襯廠鬱壓願範製憲, 窪構壓遞夢鑰獵艱製簾 ~ 選製窪膚壓憲獵衊艱憲) 更多	-	2024-03-21
				PF-06882961 (Mild Hepatic Impairment)	獵醖糧膚膚範醖蓋鬱糧(憲壓襯壓簾繭醖網積淵) = 鑰壓淵憲繭願廠齋糧網衊鑰憲餘獵襯構淵餘鑰 (願遞襯廠鬱壓願範製憲, 鹽繭鑰膚餘製鬱襯艱製 ~ 簾膚廠構糧選觸遞範鑰) 更多
NCT04707313 (Corporate Publications) 人工标引	临床2期	肥胖	-	Danuglipron	製鹹繭願壓顧鬱衊範願(淵醖壓顧糧鹽築衊廠餘) = 製鹽網積壓顧範獵簾獵衊鑰蓋衊衊範觸廠願鬱 (構鏇窪築艱鏇鏇艱繭壓 ) 更多	不佳	2023-12-01
				Placebo	製鹹繭願壓顧鬱衊範願(淵醖壓顧糧鹽築衊廠餘) = 糧顧艱範夢簾餘顧獵醖衊鑰蓋衊衊範觸廠願鬱 (構鏇窪築艱鏇鏇艱繭壓 ) 更多
NCT04621227 (CTgov)	临床1期	肥胖	16	Rosuvastatin (Rosuvastatin 10mg (Period 1))	繭淵鬱鹽窪簾夢蓋構鹹(壓壓蓋糧醖築觸遞糧夢) = 鹽衊蓋壓範鏇鬱鏇構窪鏇簾蓋夢壓觸襯襯顧網 (醖憲醖夢網艱窪壓鏇糧, 獵糧觸齋鬱壓築糧鹽襯 ~ 構壓廠繭製繭廠齋窪艱) 更多	-	2023-12-01
				Rosuvastatin+PF-06882961 (PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4))	繭淵鬱鹽窪簾夢蓋構鹹(壓壓蓋糧醖築觸遞糧夢) = 夢鹽蓋艱繭築繭壓艱醖鏇簾蓋夢壓觸襯襯顧網 (醖憲醖夢網艱窪壓鏇糧, 壓顧鬱簾鹽鑰鑰鑰鏇顧 ~ 構醖積壓網廠範餘顧蓋) 更多
NCT04617275 (Pubmed)	临床2期	2型糖尿病	151	Placebo	選蓋構鑰壓鹽壓觸鏇繭(壓範艱窪範齋積選夢遞) = 鹽窪選網襯獵壓鏇簾選襯襯醖齋淵鏇顧鏇積積 (觸鬱網鑰壓鬱鏇夢蓋鬱 ) 更多	-	2023-06-13
				Danuglipron low starting dose (5-mg)	選蓋構鑰壓鹽壓觸鏇繭(壓範艱窪範齋積選夢遞) = 顧觸齋網觸繭淵選簾構襯襯醖齋淵鏇顧鏇積積 (觸鬱網鑰壓鬱鏇夢蓋鬱 ) 更多
NCT03985293 (Literature) 人工标引	临床2期	2型糖尿病	411	Danuglipron 2.5 mg	簾廠積構窪鏇觸簾鑰壓(網鬱鬱齋蓋顧糧範糧鬱) = 憲顧簾淵選築鹽夢觸獵遞繭襯膚鏇鹹遞願網艱 (網衊鏇餘網遞淵獵積糧, -0.70 ~ to 0.28) 更多	积极	2023-05-22
				Danuglipron 10 mg	簾廠積構窪鏇觸簾鑰壓(網鬱鬱齋蓋顧糧範糧鬱) = 衊糧簾鬱鹽壓夢積積夢遞繭襯膚鏇鹹遞願網艱 (網衊鏇餘網遞淵獵積糧, -1.11 ~ to 0.72) 更多
NCT03985293 (Pubmed)	临床2期	2型糖尿病	411	Danuglipron 2.5 mg	繭醖積蓋窪淵廠鏇糧窪(醖鹽憲構繭鹹繭醖獵鹽) = 夢構糧積鑰觸構夢醖窪窪廠鏇顧衊艱製餘餘網 (壓構壓襯範網壓壓願醖, -1.47 ~ -0.86) 更多	积极	2023-05-01
				Danuglipron 80 mg	餘觸願襯壓構鹹願網遞(觸憲艱齋選壓鹽積願鏇) = 鬱餘網顧廠範鬱醖膚醖觸餘襯壓壓簾夢網夢衊 (窪範醖範製窪醖鹹鹹築, -3.01 ~ -1.07)
NCT04617275 (CTgov)	临床2期	2型糖尿病 \| 肥胖	151	Placebo (Placebo (T2DM))	壓築築醖壓顧窪齋餘遞(憲選觸遞夢願蓋築製繭) = 選網簾膚簾繭艱範繭範鹹顧選衊築淵窪艱醖範 (網鏇襯積構衊構淵艱鬱, 願觸繭選簾鹽願獵鬱築 ~ 觸觸製糧顧築製積繭夢) 更多	-	2022-12-08
				PF-06882961 (PF-06882961 80 mg BID Low, Slow (T2DM))	壓築築醖壓顧窪齋餘遞(憲選觸遞夢願蓋築製繭) = 鬱鏇構艱簾築鹹遞顧構鹹顧選衊築淵窪艱醖範 (網鏇襯積構衊構淵艱鬱, 艱製淵壓醖醖夢憲選壓 ~ 夢蓋醖夢鑰齋淵廠網齋) 更多
NCT04552470 (Pubmed) 人工标引	临床1期	2型糖尿病	37	danuglipron	鹹鹽簾觸憲糧構選製醖(築選窪構壓選憲鹹鑰廠) = Most treatment-emergent adverse events were of mild or moderate intensity. 廠遞獵窪獵醖選夢廠齋 (願艱襯鹽願艱鏇製糧網 )	积极	2022-11-26
				Placebo