Research

Hormonal

Obeticholic acid reduces liver fibrosis but does not resolve NASH, and is associated with significant side effects like pruritus and increased LDL.

Obeticholic acid can reduce liver scarring (fibrosis) but does not cure the underlying inflammation (NASH). It causes itching in over 50% of patients at higher doses and raises LDL cholesterol, which may need to be managed with statins. It is not a first-line cure.

GoodQualifiesHIGH confidence
with obeticholic acid it was not possible to achieve resolution of NASH, but individual histological features of the disease (steatosis, inflammation and ballooning of hepatocytes) were reduced. Unfortunately, two side effects of the drug were observed, reducing enthusiasm for conditional approval of obeticholic acid by the FDA. First, this is itching, the frequency of which in the study was 51% in patients receiving the drug at 25 mg/day, 28% - 10 mg/day and 19% - in the placebo group.
С. Г. Канорский · South Russian Journal of Therapeutic Practice · 2021

Why this rating

Based on Phase 3 REGULATE trial cited in the review.

Source

Non-alcoholic fatty liver disease: modern approaches to diagnosis and treatment

С. Г. Канорский · South Russian Journal of Therapeutic Practice · 2021

DOI 10.21886/2712-8156-2021-2-3-18-29

narrative_reviewCited 4×
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DOI resolved against Crossref · corpus check 2026-06-10

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