Berberine and Adiposity in Diabetes-Free Individuals With Obesity and MASLD

Berberine is a potential therapy for metabolic disorders, yet its effects on visceral adipose tissue (VAT) and liver fat remain uncertain.

To evaluate the efficacy and safety of berberine in reducing VAT area and liver fat content in diabetes-free individuals with obesity and metabolic dysfunction-associated steatotic liver disease (MASLD). Design, Setting, and Participants: In this multicenter, double-blind randomized clinical trial, diabetes-free individuals with obesity and MASLD were enrolled at 11 hospitals in China between July 6 and December 29, 2023, with a follow-up duration of 6 months. Interventions: Participants were randomly assigned to receive either oral berberine, 1 g/d, or a matching placebo. Main Outcomes and Measures: The primary outcomes were relative percentage change in VAT area and absolute change in liver fat content assessed by computed tomography. Other outcomes included changes in parameters of glucose, lipids, and inflammation. Analyses were conducted according to the intention-to-treat principle.