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NCT05442047 (coramitug in Transthyretin Amyloid Cardiomyopathy): BVCT ex-ante prediction vs. reported outcome

On 16 Jan 2025, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 10 Nov 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient (non-superior to tafamidis/acoramidis).

Clinical Trial

NCTID
NCT05442047
Drug Name
coramitug (NNC6019-0001)
Drug MoA
anti-misTTR inhibitor
Drug Modality
monoclonal antibody
Drug Class
Best-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Human Patients
105
Sponsor
Prothena Corporation / Novo Nordisk A/S
Phase
Phase 2

Prediction of , index 1367

Prospective Prediction
Prediction Index
1367
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient yet moderate clinical benefit in 6MWT/KCCQ/CV events/all-cause mortality superior to eplontersen/vutrisiran yet non-superior to tafamidis/acoramidis)
Technical Prediction
SUCCESS (statistically significant clinical benefit in 6MWT/KCCQ/CV events/all-cause mortality compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
298 days in advance
Readout Data Interpretation
coramitug failed to achieve statistically significant improvement in 6MWT or KCCQ compared with placebo at week 52, which is at least non-superior to tafamidis (see add'l link below) or acoramidis (10.1001/jamacardio.2025.4477) both of which achieved statistically significant improvement in 6MWT (p<0.001) or KCCQ (p<0.001) compared with placebo at month 30; well tolerated
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient (non-superior to tafamidis/acoramidis)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
Efficacy and Safety of NNC6019-0001 at Two Dose Levels in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Phase
Phase 2
Status
Completed
Enrollment
105
Lead sponsor
Novo Nordisk A/S
Conditions
Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Interventions
DRUG: NNC6019-0001; DRUG: Placebo (NNC6019-0001)
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-08-02
Primary completion
2025-02-17
Completion
2025-05-13
Primary outcomes
  • Change in 6-minute walk test (6-MWT) (From baseline (week 0) to visit 15 (week 52))
  • Change in N-terminal-pro brain natriuretic peptide (NT-proBNP) (From baseline (week 0) to visit 15 (week 52))

NCT05442047 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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