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NCT04136171 (Eplontersen in Transthyretin-Mediated Amyloid Cardiomyopathy): BVCT ex-ante prediction vs. reported outcome

On 12 Dec 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 9 Jul 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04136171
Acronym
CARDIO-TTRansform
Drug Name
Eplontersen
Drug MoA
GalNAc-conjugated ASO that degrades TTR mRNA
Drug Modality
antisense oligonucleotide (ASO)
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
Human Patients
1438
Sponsor
AstraZeneca / Ionis Pharmaceuticals
Phase
Phase 3

Prediction of , index 1863

Prospective Prediction
Prediction Index
1863
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet weak additive clinical benefit in 6MWT/KCCQ/all-cause mortality at most weakly superior to SoC alone (tafamidis))
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit in CV mortality/CV recurrence compared with SoC alone (tafamidis))

Readout of

Prediction Validation
Readout Date
Prediction To Readout
574 days in advance
Readout Data Interpretation
Eplontersen failed to meet the primary endpoint of the composite outcome of CV mortality and recurrent CV events compared with placebo, and particularly no treatment effect was observed in patients who were on stabilizer therapy (aka. tafamidis) at baseline
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 3 Global, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
Phase
Phase 3
Status
Completed
Enrollment
1438
Lead sponsor
Ionis Pharmaceuticals, Inc.
Conditions
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
Interventions
DRUG: Eplontersen; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2020-03-13
Primary completion
2026-03-25
Completion
2026-08-12
Primary outcomes
  • Composite Outcome of Cardiovascular (CV) Mortality and Recurrent CV Clinical Events up to Week 140 (Baseline up to Week 140)

NCT04136171 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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