Tier 2 — strong

Pharmacokinetics and pharmacodynamics of HTD1801 (berberine ursodeoxycholate, BUDCA) in patients with hyperlipidemia

Di Bisceglie AM, Watts GF, Lavin P, Yu M, Bai R, Liu L
Lipids in health and disease 2020 19(1):239

Bibliography

PubMed
PMID 33183320
PubMed Central
PMC7661247
DOI
10.1186/s12944-020-01406-4
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
The study was funded entirely by HighTide Therapeutics.
Competing interests
Several authors were HighTide employees, contractors or consultants, including the chief medical officer.

Study snapshot

DesignDouble-blind placebo-controlled dose-ranging study
ModelHuman participants; see population
Sample50 adults with hypercholesterolemia
InterventionDose-ranging HTD1801 up to 2000 mg/day versus placebo
Duration28 days
EndpointsGlycemic, lipid or liver measures; Dose response; Safety and tolerability

What the study showed, in plain terms

The highest dose of berberine ursodeoxycholate produced modest LDL and total-cholesterol reductions in an early safety/exposure study.

Key findings

  • The highest dose of berberine ursodeoxycholate produced modest LDL and total-cholesterol reductions in an early safety/exposure study.

What this study can and cannot tell us

HTD1801 is an ionic salt involving ursodeoxycholic acid, not plain berberine hydrochloride. Brief safety observation cannot establish long-term safety.

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A Randomized, Dose-Finding, Proof-of-Concept Study of Berberine Ursodeoxycholate in Patients With Primary Sclerosing Cholangitis
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Tier 2
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 et al. · Nature communications · 2021

Editorial review

Reviewed by the Biohack Blueprint research team

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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