Tier 2 — strong

Berberine and Adiposity in Diabetes-Free Individuals With Obesity and MASLD: A Randomized Clinical Trial

Lei L, Wang B, Zhao L, Li J, Yan X, Jiang J, Wang L, Ren G, Li Y, Cheng X, Yan X, Zhu Y, Guo Y, Zhong H, Zhang H, Li J, BRAVO Collaborative Group
JAMA network open 2026 9(1):e2554152

Bibliography

PubMed
PMID 41543854
PubMed Central
PMC12811813
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Supported by the China Academy of Chinese Medical Sciences Innovation Fund; study drugs were supplied free by Yunnan Biovalley Pharmaceutical.
Competing interests
The authors reported no conflicts of interest. Free study-drug supply is disclosed in the funding statement.

Study snapshot

DesignMulticenter double-blind placebo-controlled randomized trial
ModelHuman participants; see population
Sample337 randomized; 169 berberine and 168 placebo
InterventionBerberine hydrochloride 500 mg twice/day versus placebo; lifestyle advice in both arms
Duration6 months
EndpointsLiver fat and liver enzymes; Body composition and weight; Metabolic biomarkers

What the study showed, in plain terms

The BRAVO trial did not find a significant reduction in CT-measured visceral adipose tissue or liver fat in diabetes-free adults with obesity and MASLD. Exploratory lipid and inflammation changes need separate interpretation.

Key findings

  • Neither coprimary fat outcome differed significantly from placebo.
  • LDL, apoB and hs-CRP signals were secondary; adverse-event incidence was similar.

What this study can and cannot tell us

Run-in selected participants able to tolerate/adherently take berberine. Secondary and subgroup analyses were not adjusted for multiplicity.

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