Viking Therapeutics (VKTX) Study Result summary

Study design and objectives

• The phase IIb VOYAGE trial evaluated VK2809, a liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed NASH (MASH), using a randomized, double-blind, placebo-controlled, multicenter design over 52 weeks.

• Patients enrolled had at least 8% liver fat and F2/F3 fibrosis, with up to 25% F1 allowed if additional risk factors were present.

• The primary endpoint was change in liver fat at week 12; secondary endpoints included histologic changes at week 52.

Efficacy results

• VK2809 achieved clinically and statistically significant improvements in NASH resolution, fibrosis stage, and the combined endpoint of NASH resolution and fibrosis improvement.

• NASH resolution without worsening of fibrosis was seen in up to 75% of VK2809-treated patients vs. 29% for placebo at 52 weeks (p=0.0001).

• At least a one-stage improvement in fibrosis without worsening of NASH occurred in up to 57% of VK2809-treated patients vs. 34% for placebo (p<0.05).

• Both NASH resolution and fibrosis improvement were achieved in up to 48% of VK2809-treated patients vs. 20% for placebo (p=0.01).

• Results were robust across sensitivity analyses, including conservative imputation for missing data.

Liver fat and lipid outcomes

• VK2809 led to mean relative reductions in liver fat of 37%-55% at week 52, with 64%-88% of patients achieving at least a 30% reduction (all p<0.05 vs. placebo).

• 54% of VK2809-treated patients experienced at least a 50% reduction in liver fat.

• Statistically significant reductions in LDL cholesterol (20%-25%), triglycerides, ApoB, Lp(a), and ApoC-III were observed, supporting potential cardiovascular benefit.