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NCT04973657 (VK0214 in Adrenomyeloneuropathy Form of X-linked Adrenoleukodystrophy): BVCT ex-ante prediction vs. reported outcome

On 12 Oct 2022, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 9 Oct 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (no FDA approved drug for X-ALD).

Clinical Trial

NCTID
NCT04973657
Drug Name
VK0214
Drug MoA
TRbeta agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD)
Human Patients
36
Sponsor
Viking Therapeutics
Phase
Phase 1

Prediction of , index 477

Prospective Prediction
Prediction Index
477
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
728 days in advance
Readout Data Interpretation
VK0214 achieved 37.9% placebo-adjusted VLCFA reduction at day 28 (p = 0.0105) and 24.9% placebo-adjusted LDL-C reduction at day 28 (p<0.0001)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (no FDA approved drug for X-ALD)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
Phase 1b, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, PD and PK of VK0214, in Subjects With the Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD)
Phase
Phase 1
Status
Completed
Enrollment
24
Lead sponsor
Viking Therapeutics, Inc.
Conditions
Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD)
Interventions
DRUG: VK0214; OTHER: Placebo
Design
Randomized · Sequential · Quadruple
Primary purpose
Other
Start
2021-06-22
Primary completion
2024-10-09
Completion
2024-11-08
Primary outcomes
  • Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious AEs (TESAEs) (28 days)

NCT04973657 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials