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NCT04720534 (ARO-APOC3 in Severe Hypertriglyceridemia): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 7 Apr 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT04720534
Acronym
SHASTA-2
Drug Name
ARO-APOC3
Drug MoA
siRNA-GalNAc conjugate that suppresses APOC3 mRNA
Drug Modality
small interfering RNA (siRNA) antisense oligonucleotide
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Severe Hypertriglyceridemia
Human Patients
229
Sponsor
Arrowhead Pharmaceuticals
Phase
Phase 2

Prediction of , index 788

Prospective Prediction
Prediction Index
788
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
53 days in advance
Readout Data Interpretation
86% triglyceride reduction superior to 30-50% achieved by SoC (Fibrates).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Severe Hypertriglyceridemia
Phase
Phase 2
Status
Completed
Enrollment
229
Lead sponsor
Arrowhead Pharmaceuticals
Conditions
Severe Hypertriglyceridemia
Interventions
DRUG: ARO-APOC3; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-05-31
Primary completion
2023-03-09
Completion
2023-08-31
Results first posted
2026-03-24
Primary outcomes
  • Percent Change From Baseline at Week 24 in Fasting Triglycerides (TG) (Baseline, Week 24)

NCT04720534 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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