这项研究的主要目的是评价obicetrapib对重大不良心血管事件（MACE）风险的影响，包括CV死亡、非致死性心肌梗死、非致死性卒中或非选择性冠状动脉血运重建。本研究的次要目的是评价obicetrapib对以下情况的影响： 1）CV死亡、非致死性MI或非致死性卒中； 2）全因死亡、非致死性MI、非致死性卒中或非选择性冠状血管重建； 3）主要复合终点的任何单个组分； 4）总CV事件； 5）新发糖尿病（NODM）； 6）低密度脂蛋白胆固醇（LDL-C）的百分比变化； 7）非高密度脂蛋白胆固醇（非HDL C）的百分比变化； 8）载脂蛋白B（ApoB）的百分比变化；以及 9）基线时糖化血红蛋白（HbA1c）≥7%的糖尿病受试者中HbA1c的绝对变化。本研究的探索性目的是评价obicetrapib对以下情况的影响： 1）因不稳定型心绞痛和/或胸痛住院治疗； 2）因心衰（HF）住院治疗； 3）短暂性脑缺血发作（TIA）。

开始日期2022-09-27

申办/合作机构

NewAmsterdam Pharma Co. NV

[+2]

CTR20221231 / Active, not recruiting临床3期

在最大耐受调脂治疗的基础上，使用Obicetrapib对患者的影响（BROADWAY）：一项针对经调脂治疗后控制不佳的、患有潜在家族性杂合子高胆固醇血症（HeFH）和/或动脉粥样硬化性心血管疾病（ASCVD）的受试者中，评价10 mg Obicetrapib疗效的安慰剂对照、双盲、随机、III期研究

本研究的主要目的是评价在第84天时，Obicetrapib对LDL-C水平的影响。本研究的次要目的： 1）第180天和第365天时Obicetrapib对LDL-C水平的影响； 2）第84天、第180 天和第365 天时Obicetrapib对载脂蛋白B、非高密度脂蛋白胆固醇、高密度脂蛋白胆固醇、总胆固醇和甘油三酯的影响； 3）第84 天时Obicetrapib 对脂蛋白A和载脂蛋白A1的影响; 4）通过评估不良事件、特别关注事件、生命体征（包括血压）等，在成年男性和女性人群中评估Obicetrapib的安全性和耐受性特征。本研究的探索性目的： 1）Obicetrapib对第84天、第180 天和第365 天达到预先设定的LDL-C目标的受试者比例以及生物标志物等的影响； 2）Obicetrapib组中Obicetrapib从基线到第365天的谷浓度； 3）Obicetrapib对CV死亡、非致死性心肌梗死、非致死性卒中或非计划性冠状动脉血运重建的影响； 4）Obicetrapib对因不稳定型心绞痛和/或胸痛而住院治疗、因心衰和短暂性脑缺血发作而住院治疗的影响。

开始日期2022-08-31

申办/合作机构

南京希麦迪医药科技有限公司

[+2]

CTR20221278 / Completed临床1期

中国健康受试者单次和多次口服Obicetrapib片的药代动力学、药效学和安全性的随机、平行分组、开放、单中心I期临床试验。

主要目的：评价中国健康受试者单次和多次口服Obicetrapib后的PK特征。次要目的：评价中国健康受试者单次和多次口服Obicetrapib后的PD特征，探索药物的剂量-暴露-效应关系；评价中国健康受试者单次和多次口服Obicetrapib后的安全性。

开始日期2022-08-21

申办/合作机构

南京希麦迪医药科技有限公司

[+2]

100 项与南京希麦迪医药科技有限公司相关的临床结果

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0 项与南京希麦迪医药科技有限公司相关的专利（医药）

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项与南京希麦迪医药科技有限公司相关的文献（医药）

2019-05-20·Journal of Clinical Oncology

A phase I, first-in-human, dose-escalation and dose-expansion study of the multitarget kinase inhibitor TT-00420 in patients with advanced solid tumors.

作者: Ngo, Brenda ; Wu, Henry ; Piha-Paul, Sarina Anne ; Xiong, Wendy ; Peng, Peng ; Wan, Qunfang ; Yang, Xiaoju ; Wu, Frank

TPS3168 Background: Multi-target kinase inhibitors have gained increasing attention in the past few years due to their capabilities of simultaneously targeting several hallmarks of cancer. Triple negative breast cancer (TNBC), the most aggressive type of breast cancer, is a highly heterogeneous disease composed of several subtypes with distinct genomic profiles and activating pathways. TT-00420 is a multi-target kinase inhibitor that targets Aurora A/B, receptor tyrosine kinases (RTKs) involved in angiogenesis, and other kinases involved in tumor-associated inflammation and immune escape. Preclinical studies have established signs of efficacy for TT-00420 in TNBC. Targets inhibited by TT-00420 are among the key dysregulated pathways directly involved in the tumorigenesis of TNBC. TT-00420 is efficacious against most subtypes of TNBC cell lines. This anti-TNBC activity is confirmed in both cell line derived xenograft (CDX) and patient derived xenograft (PDX) TNBC model in vivo, in which TT-00420 is active both as first-line and second-line treatment. TT-00420 demonstrated good oral bioavailability and pharmacokinetic properties in mice, rats and dogs, and revealed mechanism-related but manageable toxicities. The IND approval of TT-00420 was granted by the FDA on Sept. 27, 2018. Methods: TT420X2101 is an open-label, first-in-human, multicenter, phase I study including a dose escalation portion in adult patients with advanced solid tumors, followed by dose expansion in two parallel cohorts, TNBC cohort (N=22) and selected advanced tumor (SAT) cohort (N=22). Adverse events will be evaluated per CTCAE v5.0 criteria, and tumor responses will be evaluated per RECIST v1.1 criteria. Patients aged 18-75 with measurable target lesion(s) at baseline and ECOG status of 0 or 1 will be enrolled. Patients are treated with a single daily oral administration of TT-00420 continuously for a 28-day cycle. Dose escalation is driven by Bayesian modeling with over-dose control. Approximately 66 patients are expected to be enrolled and treated in this study. Primary endpoint is to evaluate dose limiting toxicity (DLT) and identify maximum tolerate dose (MTD), if feasible, or establish recommended dose for Dose Expansion. Preliminary efficacy and PK profile will be evaluated as well. Enrollment is currently ongoing. Clinical trial information: NCT03654547.

Frontiers in Endocrinology

Associaton of Retinol Binding Protein 4 (RBP4) Levels With Hyperuricemia: A Cross-Sectional Study in a Chinese Population

Article

作者: Ke, Xiao-Su ; Li, Jia-Min ; Gao, Pei-Chun ; Ning, Jing ; Shao, Xiao-Fei ; Zhou, Qin ; Chen, Hai-Shan ; Zou, Hequn ; Li, Xiao-Lin ; Xiao, Hua ; Hong, Guo-Bao ; Xiong, Chong-Xiang

BackgroundThere are few studies on predictive biomarkers for hyperuricemia, and the predictive value of these biomarkers tends to be poor. Additionally, no reports have described the predictive value of retinol binding protein 4 (RBP4) for hyperuricemia.PurposeThis study was performed to evaluate the value of RBP4 for predicting the risk of hyperuricemia in a general population, determine whether RBP4 could be used alone or in combination with other factors to predict the risk of hyperuricemia in the general population, and establish an optimum predictive model.MethodsWe conducted a population-based cross-sectional survey in 2018, involving a questionnaire, physical examination, and laboratory testing. We enrolled 2303 individuals by stratified random sampling, and 2075 were included in the data analysis after applying the eligibility criteria.ResultsSerum RBP4 level had a highly significant association with hyperuricemia (P<0.001). After adjusting for potential confounders, logistic regression indicated that the risk of hyperuricemia was highest in the highest RBP4 quartile (odds ratio: 7.9, 95% confidence interval [CI]: 4.18–14.84, compared to the lowest quartile). The area under the receiver operating characteristic (ROC) curve (AUC) for RBP4 was 0.749 (95% CI: 0.725–0.774, P<0.001), which was higher than that for all the other predictors assessed. The optimum model for predicting hyperuricemia in the general population consisted of RBP4, sex (male), body mass index, serum creatinine, high-sensitivity C-reactive protein, fasting blood glucose, insulin, and alcohol consumption. The AUC was 0.804 (95% CI: 0.782–0.826, P<0.001).ConclusionsRBP4 is strongly associated with hyperuricemia, and its predictive value was higher than that of traditional predictors.

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