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NCT05552326 (Olezarsen in Severe Hypertriglyceridemia): BVCT ex-ante prediction vs. reported outcome

On 3 Jan 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 2 Sep 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (non-superior-non-inferior to plozasiran).

Clinical Trial

NCTID
NCT05552326
Acronym
CORE2
Drug Name
Olezarsen
Drug MoA
GalNAc3-conjugated anti-APOC3
Drug Modality
antisense oligonucleotide (ASO)
Drug Class
Best-In-Class
Therapeutic Area
Cardiovascular Diseases and Nutritional and Metabolic Diseases
Indication
Severe Hypertriglyceridemia
Human Patients
446
Sponsor
Ionis Pharmaceuticals
Phase
Phase 3

Prediction of , index 1406

Prospective Prediction
Prediction Index
1406
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit non-superior non-inferior to plozasiran)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
608 days in advance
Readout Data Interpretation
Olezarsen achieved 55-73% placebo-adjusted reduction in fasting triglycerides (p<0.0001) and 85% placebo-adjusted reduction in acute pancreatitis attacks (p<0.0001); non-superior-non-inferior to plozasiran that achieved 61-63% placebo-adjusted reduction in fasting triglycerides (p<0.001) and 83% placebo-adjusted reduction in acute pancreatitis attacks (p=0.03)(see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (non-superior-non-inferior to plozasiran)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia
Phase
Phase 3
Status
Completed
Enrollment
446
Lead sponsor
Ionis Pharmaceuticals, Inc.
Conditions
Severe Hypertriglyceridemia
Interventions
DRUG: Olezarsen; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-08-31
Primary completion
2024-12-17
Completion
2025-09-12
Primary outcomes
  • Percent Change from Baseline in Fasting TG Compared to Placebo (Baseline and Month 6)

NCT05552326 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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