A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH
Summary
The study includes 52 weeks, double-blind treatment period. Clinic visits will occur at Randomization and every four weeks from Week 4 through Week 52 and through End of Study period. The study includes a post-dosing study visit that will occur 4 weeks after the last dose of study drug. This visit represents the End-of-Study Visit (Week 56 Visit). Three hundred thirty-seven subjects will be enrolled into five treatment arms and there will be an equal distribution of males and females in each treatment arm. Subjects will be stratified by gender, fibrosis stage, and diabetes status.
Timeline
- Start
- 2019-11-15
- Primary completion
- 2023-05-15
- Completion
- 2024-01-26
Outcome
Met primary endpoint
release “Phase 2b clinical trial of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) achieved its primary endpoint” ligand.com ↗
release “VOYAGE study successfully achieved its primary endpoint, with patients receiving VK2809 experiencing statistically significant reductions in liver fat content” vikingtherapeutics.com ↗
release “The presentation summarized the final 52-week data from the VOYAGE study, showing that VK2809 successfully achieved the trial's primary and secondary endpoints.” vikingtherapeutics.com ↗
release “The compound successfully achieved both the primary and secondary endpoints in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis.” vikingtherapeutics.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MB07811 | Small molecule | 1 mg | — |
| Subject | MB07811 | Small molecule | 2.5 mg | — |
| Subject | MB07811 | Small molecule | 5 mg | — |
| Subject | MB07811 | Small molecule | 10 mg | — |