Viking Therapeutics reports results from Phase 2b clinical trial of VK2809

Viking Therapeutics (VKTX) announced that final results from the company’s Phase 2b clinical trial of VK2809, the company’s novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis were highlighted in an oral late breaker presentation at the 75th Liver Meeting 2024, the annual meeting of the American Association for the Study of Liver Disease, or AASLD. The presentation summarized the final 52-week data from the VOYAGE study, showing that VK2809 successfully achieved the trial’s primary and secondary endpoints while demonstrating excellent tolerability and promising safety. Patients receiving VK2809 demonstrated statistically significant reductions in liver fat at Week 12, which was the primary endpoint in VOYAGE. Importantly, patients receiving VK2809 continued to demonstrate statistically significant reductions in liver fat content at Week 52, with the mean relative change from baseline ranging from 37% to 55%. 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. Resolution of NASH was defined as a non-alcoholic fatty liver disease activity score of 0 or 1 for inflammation and 0 for ballooning. 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.