Analyzing MASLD interventional clinical trial registration based on the ClinicalTrials.gov database

Area of Science:

• Hepatology and Clinical Trial Design
• Pharmacological Research and Drug Development

Background:

• Metabolic dysfunction-associated steatotic liver disease (MASLD) incidence is rising globally.
• Extensive drug research and clinical trials are underway to develop MASLD therapeutics.

Purpose of the Study:

• To examine the design principles and research objectives of MASLD therapeutics.
• To provide guidance for clinical trial participants and decision-makers in MASLD research.

Main Methods:

• A systematic search of clinicaltrials.gov identified 1209 interventional clinical trials for MASLD.
• Trials were evaluated based on clinical stage, design, intervention, and outcome metrics.

Main Results:

• Research on MASLD has significantly increased, with 83.54% of trials registered from 2013-2024.
• Parallel designs (72.21%) dominate MASLD trials, with primary outcomes including histological improvement, fat content, and adverse events.
• Drug interventions focus on metabolic/energy balance, inflammation, and lipid reduction, targeting PPAR, FXR, ACC, and GLP-1.

Conclusions:

• Global MASLD clinical trials are predominantly drug-focused.
• Interventions targeting inflammation and metabolic pathways remain the primary strategy in MASLD drug development.