Acute Hip Fracture Study in Patients 65 Years or Greater
Summary
This is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to investigate the safety, tolerability, and efficacy of VK5211 after 12 weeks of treatment. Males and females ≥65 years old who are ambulatory and recovering from a hip fracture will be eligible for participation 3-7 weeks post-injury.
Timeline
- Start
- 2015-10-30
- Primary completion
- 2017-11-15
- Completion
- 2017-12-17
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs VK5211- 0.5mg; p = 0.0032; Mean Difference (Final Values) 4.75 (95% CI 1.70 to 7.80); ANCOVA NCT02578095 ↗
registry analysis (superiority test); Placebo vs VK5211- 1.0mg; p <0.0001; Mean Difference (Final Values) 7.15 (95% CI 3.76 to 10.54); ANCOVA NCT02578095 ↗
registry analysis (superiority test); Placebo vs VK5211- 2.0mg; p <0.0001; Mean Difference (Final Values) 9.08 (95% CI 5.55 to 12.60); ANCOVA NCT02578095 ↗
release “Phase 2 clinical trial of VK5211 in patients recovering from hip fracture meets primary and secondary endpoints.” vikingtherapeutics.com ↗
release “Study Achieves Primary Endpoint, Demonstrating Statistically Significant, Dose-Dependent Increases in Lean Body Mass Ranging from 4.8% to 9.1% Following Treatment with VK5211” vikingtherapeutics.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VK5211 | Small molecule | 0.5 mg | — |
| Subject | VK5211 | Small molecule | 1 mg | — |
| Subject | VK5211 | Small molecule | 2 mg | — |
Indications
No indication recorded.