Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
Summary
This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering LDL-C and liver fat content in patients with primary hypercholesterolemia and fatty liver disease. The primary efficacy endpoint is percent change from baseline LDL-C at the end of the treatment period (Week 12). Secondary endpoints include effects on liver fat content and other liver and lipid markers, as well as effects on safety and tolerability, and pharmacokinetic (PK) measurements.
Timeline
- Start
- 2016-09-28
- Primary completion
- 2019-03-26
- Completion
- 2019-03-26
Outcome
Met primary endpoint
release “VK2809 successfully achieved primary and secondary endpoints in a Phase 2a study for the treatment of patients with elevated LDL-C and non-alcoholic fatty liver disease” ligand.com ↗
release “Study Achieves Primary Endpoint, Demonstrating Statistically Significant Reductions in LDL-C in Patients Receiving VK2809” vikingtherapeutics.com ↗
release “Phase 2 study of VK2809 in patients with NAFLD and elevated LDL-C achieves primary and secondary endpoints.” vikingtherapeutics.com ↗
release “12-week Phase 2 trial of VK2809 in patients with hypercholesterolemia and NAFLD, which achieved both its primary and secondary endpoints” vikingtherapeutics.com ↗
release “Phase 2a study in patients with non-alcoholic fatty liver disease and hypercholesterolemia successfully achieved its primary and secondary endpoints, with VK2809-treated patients” vikingtherapeutics.com ↗
release “A prior 12-week Phase 2a study evaluating VK2809 in patients with non-alcoholic fatty-liver disease and hypercholesterolemia, successfully achieved both its primary and secondary endpoints” vikingtherapeutics.com ↗
release “The company's prior 12-week Phase 2a trial of VK2809 in patients with hypercholesterolemia and NAFLD successfully achieved both its primary and secondary endpoints” vikingtherapeutics.com ↗
release “VK2809 also successfully achieved primary and secondary endpoints in a Phase 2a study” vikingtherapeutics.com ↗
release “VK2809 also successfully achieved primary and secondary endpoints in a Phase 2a study for the treatment of patients with elevated LDL-C” vikingtherapeutics.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MB07811 | Small molecule | 5 mg | — |
| Subject | MB07811 | Small molecule | 10 mg | — |