How far has non-invasive testing become a surrogate endpoint for the research and development of new drugs for metabolic dysfunction-associated steatohepatitis?
10.3760/cma.j.cn501113-20250904-00367
- VernacularTitle:无创检测成为代谢相关脂肪性肝炎新药研发的替代终点还有多远？
- Author:
Yameng SUN
1
;
Hong YOU
1
Author Information
1. 首都医科大学附属北京友谊医院肝病中心 消化健康全国重点实验室 国家消化系统疾病临床医学研究中心，北京 100050
- Publication Type:Journal Article
- Keywords:
Metabolic dysfunction-associated steatohepatitis;
Non-invasive tests;
Surrogate endpoint;
Diagnosis
- From:
Chinese Journal of Hepatology
2025;33(10):955-957
- CountryChina
- Language:Chinese
-
Abstract:
The research and development of new drugs for metabolic dysfunction-associated steatohepatitis still leads to a high screening failure rate and low efficiency with the repeated liver biopsy as the primary endpoint. Currently, non-invasive testing has been widely used in early-stage efficacy evaluation and patient screening, and evidence of association with clinical outcomes has gradually been established, and a number of new non-invasive scoring systems are also emerging. With the accumulation of data and the improvement of standards, the research and development of new drugs for metabolic dysfunction-associated steatohepatitis is gradually moving from the "histological era" to the "non-invasive era," which is expected to profoundly change clinical trials and disease management strategies.
