Viking Therapeutics announced the initiation of a phase 2b trial of VK2809, a novel liver-selective thyroid hormone receptor beta agonist undergoing investigation for patients with nonalcoholic steatohepatitis, according to a press release.
“We are excited to advance VK2809 into the next stage of development and look forward to assessing its safety and efficacy in this important trial,” Brian Lian, PhD, CEO of Viking, said in the release. “Given the high unmet need for new therapies to treat NASH, and VK2809’s promising initial data on both liver fat and plasma lipids, we plan to move forward as quickly as possible to demonstrate the drug’s potential benefit in this setting.”
The randomized control VOYAGE study will assess the safety and tolerability of VK2809 in patients with NASH and fibrosis stage 1 to stage 3, as well as the treatment’s efficacy in reducing liver fat content. Patients enrolled may also have comorbid conditions such as type 2 diabetes or currently receiving lipid-lowering medications.
Secondary objectives include histologic changes assessed by liver biopsy after 52 weeks of treatment.
VK2809 has been evaluated in six completed clinical studies, which comprised more than 260 patients. To date, researchers have observed no serious adverse events and overall tolerability “remains encouraging.”