BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04173065 (VK2809 in NASH - Nonalcoholic Steatohepatitis): BVCT ex-ante prediction vs. reported outcome

On 16 Oct 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 4 Jun 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (superior to resmetirom).

Clinical Trial

NCTID
NCT04173065
Acronym
VOYAGE
Drug Name
VK2809
Drug MoA
liver-selective thyroid hormone receptor beta (TRβ) agonist
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
NASH - Nonalcoholic Steatohepatitis
Human Patients
248
Sponsor
Viking Therapeutics
Phase
Phase 2

Prediction of , index 475

Prospective Prediction
Prediction Index
475
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
232 days in advance
Readout Data Interpretation
39.7% NASH resolution without worsening of fibrosis combined and 17% fibrosis improvement without worsening of NASH (vs 16-20% and 10-12% for resmetirom).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (superior to resmetirom)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
VK2809 A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of VK2809 Administered for 52 Weeks Followed by a 4-Week Off-Drug Phase in Subjects With Biopsy Proven Non-Alcoholic Steatohepatitis With Fibrosis
Phase
Phase 2
Status
Completed
Enrollment
248
Lead sponsor
Viking Therapeutics, Inc.
Conditions
NASH - Nonalcoholic Steatohepatitis
Interventions
DRUG: VK2809; DRUG: Placebos
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2019-11-15
Primary completion
2023-05-15
Completion
2024-01-26
Primary outcomes
  • Liver Fat (12 weeks)

NCT04173065 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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