Safety, pharmacokinetics and efficacy of the novel pan-phosphodiesterase inhibitor ZSP1601 in 36 NASH patients: a double-blinded, placebo-controlled, multiple-dose escalation phase Ib study

Hu, Yue; Li, Hai Jun; Zhang, Hong; Chen, Jinjun; Xu, Zhigang; You, Hong; Dong, Ruihua; Zhu, Xiaodong; Chen, Hong; Peng, Yun; Li, Jing; Li, Xiaojiao; Zhang, Lei; Cao, Dengqing; He, Jie; Qiu, Dongdong; Yang, Aruhan; Liu, Jingrui; Jia, Hao; Lou, Jinfeng; Niu, Junqi; Ding, Yanhua

doi:10.1016/s0168-8278(22)00571-2

Cited by 1 publication

(4 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In phase I and IIa clinical trials, ZSP1601 has been shown to have good safety and pharmacokinetic profiles. 74,75 Compared with placebo, treatment with ZSP1601 resulted in a significant decline in liver enzymes, LFC and FibroScan-aspartate aminotransferase (AST) score in a dose-dependent manner after 28 days of treatment in patients with NASH. Moreover, ZSP1601 also significantly decreased body weight, BMI, waist circumstance, low-density lipoprotein cholesterol, cytokeratin-18 levels and AST/platelet ratio index relative to baseline.…”

Section: A Phase II Trial Investigating the Efficacy And Safety Of Ch...mentioning

confidence: 99%

“…Moreover, ZSP1601 also significantly decreased body weight, BMI, waist circumstance, low-density lipoprotein cholesterol, cytokeratin-18 levels and AST/platelet ratio index relative to baseline. 75 Other novel drugs developed in China, including tricyclic farnesoid X receptor agonists and thyroid hormone receptor-β agonists, are also underway in phase I or II clinical trials (Table 3).…”

Section: A Phase II Trial Investigating the Efficacy And Safety Of Ch...mentioning

confidence: 99%

“…This agent has similar efficacy and better safety profiles than obeticholic acid in NASH animal models. In phase I and IIa clinical trials, ZSP1601 has been shown to have good safety and pharmacokinetic profiles 74,75 . Compared with placebo, treatment with ZSP1601 resulted in a significant decline in liver enzymes, LFC and FibroScan‐aspartate aminotransferase (AST) score in a dose‐dependent manner after 28 days of treatment in patients with NASH.…”

Section: Advances In Nafld/nash Treatment Regimens In Chinamentioning

confidence: 99%

“…Compared with placebo, treatment with ZSP1601 resulted in a significant decline in liver enzymes, LFC and FibroScan‐aspartate aminotransferase (AST) score in a dose‐dependent manner after 28 days of treatment in patients with NASH. Moreover, ZSP1601 also significantly decreased body weight, BMI, waist circumstance, low‐density lipoprotein cholesterol, cytokeratin‐18 levels and AST/platelet ratio index relative to baseline 75 . Other novel drugs developed in China, including tricyclic farnesoid X receptor agonists and thyroid hormone receptor‐β agonists, are also underway in phase I or II clinical trials (Table 3).…”

Section: Advances In Nafld/nash Treatment Regimens In Chinamentioning

confidence: 99%

See 3 more Smart Citations

Epidemiological characteristics and management of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis in China: A narrative review

Liu

Hong

2023

Diabetes Obesity Metabolism

View full text Add to dashboard Cite

Aim With industrialization and spread of the westernized lifestyle, the number of people affected by non‐alcoholic fatty liver disease (NAFLD)/non‐alcoholic steatohepatitis (NASH) is growing rapidly in China; this has become a major public health concern. To better understand the burden and characteristics of NAFLD/NASH in China, we aim to perform a narrative review of the literature published in this field. Materials and Methods We carried out a comprehensive electronic search of five English‐language and three Chinese‐language databases, to identify studies regarding NAFLD or NASH published from inception to November 30, 2022. Epidemiological studies of NAFLD/NASH in China were particularly noticed and summarized. We also searched the http://www.clinicaltrials.gov and http://www.chictr.org.cn websites for the registered trials on the treatment of the disease led by Chinese investigators or located in China. Results The increasing rate of NAFLD prevalence in China is strikingly high, reaching more than twice that in western countries. The prevalence of NAFLD is nearly 30% of the general Chinese population, making it the leading cause of chronic liver diseases. The prevalence of NAFLD/NASH varies between provinces/regions, age groups, sexes, and individuals with different metabolic profiles. NAFLD co‐exists in many Chinese patients with chronic hepatitis B. Since 2020, more Chinese studies have used the term metabolic‐associated fatty liver disease (MAFLD), emphasizing the underlying metabolic disorders that occur concurrently with this disease. Several clinical trials involving lifestyle interventions, antidiabetic drugs, or traditional Chinese medicines, registered by Chinese investigators, have been completed or are ongoing. Moreover, several innovative targeted therapies developed in China are revolutionizing the treatment of NAFLD/NASH. Conclusions NAFLD has cast a heavy burden on the Chinese healthcare system. Chinese scholars are making efforts to achieve the optimal management of this disease.

show abstract

Section: A Phase II Trial Investigating the Efficacy And Safety Of Ch...mentioning

confidence: 99%

Section: A Phase II Trial Investigating the Efficacy And Safety Of Ch...mentioning

confidence: 99%

Section: Advances In Nafld/nash Treatment Regimens In Chinamentioning

confidence: 99%

Section: Advances In Nafld/nash Treatment Regimens In Chinamentioning

confidence: 99%

See 2 more Smart Citations

Epidemiological characteristics and management of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis in China: A narrative review

Liu

Hong

2023

Diabetes Obesity Metabolism

View full text Add to dashboard Cite

show abstract

Safety, pharmacokinetics and efficacy of the novel pan-phosphodiesterase inhibitor ZSP1601 in 36 NASH patients: a double-blinded, placebo-controlled, multiple-dose escalation phase Ib study

Cited by 1 publication

References 0 publications

Epidemiological characteristics and management of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis in China: A narrative review

Epidemiological characteristics and management of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis in China: A narrative review

Contact Info

Product

Resources

About