Tier 2 — strong

A Randomized, Dose-Finding, Proof-of-Concept Study of Berberine Ursodeoxycholate in Patients With Primary Sclerosing Cholangitis

Kowdley KV, Forman L, Eksteen B, Gunn N, Sundaram V, Landis C, Harrison SA, Levy C, Liberman A, Di Bisceglie AM, Hirschfield GM
The American journal of gastroenterology 2022 117(11):1805-1815

Bibliography

PubMed
PMID 36327436
DOI
10.14309/ajg.0000000000001956
Funding
Funding was not established from the accessible source; this is not a declaration of no funding.
Competing interests
A complete competing-interest declaration was not available in the accessible source; no absence of conflicts is inferred.

Study snapshot

DesignRandomized dose-finding proof-of-concept study
ModelHuman participants; see population
Sample55 adults with primary sclerosing cholangitis
InterventionHTD1801 500 or 1000 mg twice/day; placebo and withdrawal periods
Duration18 weeks in three 6-week periods
EndpointsGlycemic, lipid or liver measures; Dose response; Safety and tolerability

What the study showed, in plain terms

HTD1801 lowered alkaline phosphatase during the controlled phase. Values rose after withdrawal in participants switched to placebo.

Key findings

  • HTD1801 lowered alkaline phosphatase during the controlled phase. Values rose after withdrawal in participants switched to placebo.

What this study can and cannot tell us

Alkaline phosphatase is a surrogate; no conclusion about survival or transplant prevention. This compound is distinct from retail berberine.

Source detail: indexed abstract and bibliographic record; unavailable methods or disclosures are identified rather than assumed.

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Editorial review

Reviewed by the Biohack Blueprint research team

Last verified

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