Tier 2 — strong

A phase 2, proof of concept, randomised controlled trial of berberine ursodeoxycholate in patients with presumed non-alcoholic steatohepatitis and type 2 diabetes

Harrison SA, Gunn N, Neff GW, Kohli A, Liu L, Flyer A, Goldkind L, Di Bisceglie AM
Nature communications 2021 12(1):5503

Bibliography

PubMed
PMID 34535644
PubMed Central
PMC8448729
DOI
10.1038/s41467-021-25701-5
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Industry-supported HTD1801 development study; HighTide involvement is disclosed.
Competing interests
Several authors reported HighTide employment or consulting; clinical investigators also disclosed wider industry research and consulting relationships.

Study snapshot

DesignDouble-blind placebo-controlled phase II randomized trial
ModelHuman participants; see population
Sample100 adults with presumed NASH and diabetes
InterventionHTD1801 at two doses, including 1000 mg twice/day, versus placebo
Duration18 weeks
EndpointsGlycemic, lipid or liver measures; Dose response; Safety and tolerability

What the study showed, in plain terms

The higher dose reduced MRI-measured liver fat more than placebo and improved selected glycemic measures.

Key findings

  • Absolute liver-fat reduction was 4.8 percentage points versus 2.0 with placebo in the high-dose comparison.
  • Diarrhea and abdominal discomfort were common reported complaints.

What this study can and cannot tell us

A distinct investigational compound; do not transfer results or doses to ordinary berberine supplements. Presumed NASH was not established by a biopsy endpoint.

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Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes: A Randomized Clinical Trial
Ji L et al. · JAMA network open · 2025
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A Randomized, Dose-Finding, Proof-of-Concept Study of Berberine Ursodeoxycholate in Patients With Primary Sclerosing Cholangitis
Kowdley KV et al. · The American journal of gastroenterology · 2022
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Pharmacokinetics and pharmacodynamics of HTD1801 (berberine ursodeoxycholate, BUDCA) in patients with hyperlipidemia
Di Bisceglie AM et al. · Lipids in health and disease · 2020

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology