The global clinical trial landscape for non-alcoholic fatty liver disease (NAFLD): current status and future...

Area of Science:

• Hepatology
• Clinical Pharmacology
• Translational Medicine

Background:

• Non-alcoholic fatty liver disease (NAFLD) is a growing global health concern.
• Current therapeutic strategies for NAFLD are limited, necessitating further research and development.
• Understanding the landscape of clinical trials is crucial for advancing NAFLD treatment.

Purpose of the Study:

• To comprehensively analyze the global clinical trials for non-alcoholic fatty liver disease (NAFLD) therapy.
• To depict the current landscape and future prospects of NAFLD clinical research.
• To investigate the role of glucagon-like peptide-1 receptor (GLP-1 R) agonists in NAFLD.

Main Methods:

• Collected data from 2,242 clinical trials using the Trialtrove database.
• Performed molecular docking to assess the binding affinity of GLP-1 R agonists (e.g., semaglutide) to the GLP-1 R protein.
• Analyzed transcriptome data to evaluate GLP-1 R expression in healthy and NAFLD liver samples.

Main Results:

• The US and China lead in NAFLD clinical trials, indicating geographic disparities.
• Phase IV trials constitute the largest proportion (34.10%) of NAFLD research.
• GLP-1 R agonists are the most frequently investigated agents, with significantly downregulated GLP-1 R expression observed in NAFLD, particularly in advanced stages like NASH.

Conclusions:

• GLP-1 R agonists represent a promising therapeutic avenue for NAFLD.
• Further research into GLP-1 R signaling pathways is warranted.
• The findings provide valuable insights into the current status and future directions of NAFLD clinical trials.