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NCT04945460 (Sotatercept in combined post- and precapillary pulmonary hypertension…): BVCT ex-ante prediction vs. reported outcome

On 1 Apr 2025, BioinvestGPT's BVCT predicted technical partial failure and commercial failure for this trial. The 29 Mar 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically partially significant (PVR met but 6MWD not met) and commercially insufficient.

Clinical Trial

NCTID
NCT04945460
Acronym
CADENCE
Drug Name
Sotatercept
Drug MoA
ActRIIA/ACVR2A ligand trap
Drug Modality
fusion protein biologic
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF)
Human Patients
164
Sponsor
Merck & Co.
Phase
Phase 2

Prediction of , index 1957

Prospective Prediction
Prediction Index
1957
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in PVR/6MWD/LVEF inferior to semaglutide as an adjunctive therapy)
Technical Prediction
partial FAILURE (statistically maybe significant yet very weak additive clinical benefit in PVR/6MWD/LVEF compared with placebo as an adjunctive therapy)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
362 days in advance
Readout Data Interpretation
sotatercept achieved statistical significance in PVR compared with placebo at week 24 (1.02 Wood units reduction with p=0.004 for 0.3 mg/kg dose, yet only 0.75 Wood units reduction with p=0.024 for 0.7 mg/kg dose), yet didn't achieve statistical significance in the registration endpoint 6MWD (no statistically significant placebo-adjusted improvement)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically partially significant (PVR met but 6MWD not met) 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 2, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Sotatercept Versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)
Phase
Phase 2
Status
Completed
Enrollment
165
Lead sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Conditions
Hypertension, Pulmonary
Interventions
DRUG: Sotatercept 0.3 mg/kg; DRUG: Placebo; DRUG: Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2021-12-29
Primary completion
2025-09-05
Completion
2026-04-09
Results first posted
2026-09-23
Primary outcomes
  • Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24 (Baseline and Week 24)

NCT04945460 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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