Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of an Acetonic Milk Thistle Extract Standardized to Silymarin in Subjects with Metabolic Dysfunction-Associated Steatotic Liver Disease

The primary objective of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of an acetonic milk thistle extract, standardized to silymarin, in subjects diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD). Assessing these parameters is clinically relevant to determining the absorption, distribution, metabolism, and excretion of the extract, while ensuring the intervention does not induce adverse effects in patients with chronic liver disease.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients diagnosed with chronic liver disease. The cohort includes both male and female individuals. Based on the age range codes provided, the participants fall within specific age categories.

This Phase 3 clinical trial is designed to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of an acetonic milk thistle extract, standardized to silymarin, in subjects diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD). The study involves a sequence of scheduled assessments beginning with a screening visit to determine eligibility. Subsequent follow-up visits are conducted to monitor clinical parameters and safety profiles. The protocol concludes with an end-of-study visit. Total participant involvement is determined by the study duration, which is estimated to span from January 2026 to November 2026. Early termination of participation may occur based on predefined clinical criteria or safety concerns.

Efficacy assessment in this phase 3 clinical trial involves the evaluation of parameters related to chronic liver disease. The specific endpoints and methodologies for measuring clinical response are not defined.