Viking Therapeutics Inc ( VKTX ) released 52-week histologic data from its Phase 2b VOYAGE study of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH).

As previously reported, the study achieved its primary endpoint, with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to Week 12 compared to placebo.

The results announced highlight the achievement of secondary endpoints evaluating histologic changes assessed by hepatic biopsy after 52 weeks of treatment with VK2809.

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On the secondary endpoint of NASH resolution with no worsening of fibrosis, VK2809-treated patients demonstrated NASH resolution ranging from 63% to 75%, compared with 29% for placebo.

Across the combined VK2809 treatment groups, 69% achieved NASH resolution.

On the secondary endpoint evaluating improvement in fibrosis with no worsening of NASH, VK2809-treated patients demonstrated improvement in fibrosis ranging from 44% to 57%, compared with 34% for placebo.

Across the combined VK2809 treatment groups, 51% achieved improvement in fibrosis with no worsening of NASH.

On the secondary endpoint evaluating the proportion of patients experiencing both resolution of NASH and improvement in fibrosis, VK2809-treated patients demonstrated improvement between 40% to 50%, compared with 20% for placebo.

Up to 44% achieved this endpoint.

After 52 weeks, plasma levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (liver enzymes) were reduced in every treatment arm receiving VK2809 compared with patients receiving placebo, though not all treatment arms achieved statistically significant improvement vs. placebo.

Price Action: VKTX shares are up 5.19% at $65.50 during the premarket session at last check Tuesday.

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