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Study type: Randomized controlled trialConfidence: High

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

Lei L, et al.

Year2026
Sample sizen=337
JournalJAMA Network Open
AuthorsLei L, et al.

High-confidence evidence from multiple solid studies

Summary

Summary

A multicenter, double-blind RCT in 337 diabetes-free patients with obesity and MASLD taking 1 g/day of berberine for six months. **The primary endpoints — visceral adipose tissue area (1.4%, 97.5% CI −2.4 to 5.2) and liver fat content (0.9%, 97.5% CI −0.4 to 2.1) — showed no significant difference from placebo.** Among secondary endpoints, LDL cholesterol (−7.72 mg/dL, 95% CI −13.13 to −1.93), apolipoprotein B (−3.42 mg/dL, 95% CI −6.33 to −0.51) and hs-CRP (−0.072 mg/dL, 95% CI −0.140 to −0.004) did differ, but other secondary outcomes did not. These are secondary findings in a trial whose primary endpoints were negative, and are not confirmatory.

Source (read the original)

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DOI: 10.1001/jamanetworkopen.2025.54152

Key Findings

Key findings

  • 1

    The primary endpoint, visceral adipose tissue area, did not differ from placebo (1.4%, 97.5% CI −2.4 to 5.2)

  • 2

    Liver fat content, the co-primary endpoint, also showed no difference (0.9%, 97.5% CI −0.4 to 2.1)

  • 3

    Among secondary endpoints, LDL cholesterol fell 7.72 mg/dL (95% CI −13.13 to −1.93)

  • 4

    Apolipoprotein B fell 3.42 mg/dL (95% CI −6.33 to −0.51) and hs-CRP 0.072 mg/dL (95% CI −0.140 to −0.004)

  • 5

    Other secondary outcomes did not move; these remain secondary findings in a trial with negative primary endpoints

  • 6

    337 diabetes-free patients with obesity and MASLD; adverse event rates were similar between arms

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