Approval Probability
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Adjusted LOA
ML Risk
VK2809 · 2 trials · 3 indications
Relative change in liver fat content (assessed by MRI-PDFF) from baseline to Week 12 in subjects treated with VK2809 compared to the change in subjects treated with placebo.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| 1.0 mg | EXPERIMENTAL | - |
| 2.5mg | EXPERIMENTAL | - |
| 5.0 mg | EXPERIMENTAL | - |
| 10 mg | EXPERIMENTAL | - |
| VK2809 (5mg) | EXPERIMENTAL | 5mg VK2809 capsule |
| VK2809 (10mg) | EXPERIMENTAL | 10mg VK2809 capsule |
| VK2809 (10mg QOD) | EXPERIMENTAL | 10mg VK2809 capsule |
| Name | Type | Description |
|---|---|---|
| VK2809 | DRUG | Capsule |
| Placebos | DRUG | Capsule |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Provide a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study and is willing and able to participate; 2. Have a histologically-confirmed diagnosis of...
VK2809 is an investigational small molecule developed by Viking Therapeutics, Inc. (ticker VKTX) for hyperlipidemia and NASH, or nonalcoholic steatohepatitis. It is a Phase 2 oral drug candidate that has been studied in placebo-controlled, double-blind clinical trials in adults with these liver and lipid conditions.
VK2809 targets the thyroid receptor, a nuclear receptor. By acting on this receptor, the drug is designed to influence lipid metabolism and liver fat, which is the basis for its study in hyperlipidemia and NASH. It is a small molecule administered orally.
Viking Therapeutics, Inc., which trades under the ticker VKTX, is developing VK2809. The company has sponsored the clinical trials evaluating the drug in hyperlipidemia, nonalcoholic fatty liver disease, and biopsy-proven NASH.
VK2809 is in Phase 2 development. It is investigational and has not been approved by the FDA. The completed Phase 2 program includes a 52-week biopsy-proven NASH study and an earlier Phase 2 study in primary hypercholesterolemia with nonalcoholic fatty liver disease.
VK2809 has been evaluated in two completed Phase 2 trials. NCT04173065 studied VK2809 for 52 weeks in 248 subjects with biopsy-proven NASH across the United States, Belgium, France, Mexico, and Puerto Rico. NCT02927184 studied safety and tolerability in 59 patients with primary hypercholesterolemia and nonalcoholic fatty liver disease in the United States.
VK2809 is being developed for NASH, or nonalcoholic steatohepatitis, a liver condition. Its Phase 2 trial NCT04173065 enrolled 248 adults with biopsy-proven NASH and ran for 52 weeks. The drug is also being studied for hyperlipidemia, a condition involving elevated blood lipids.