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NCT05142722 (Obicetrapib in Atherosclerotic Cardiovascular Disease / Heterozygous familial…): BVCT ex-ante prediction vs. reported outcome

On 12 May 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 10 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant (insignificant MACE reduction benefit) and commercially insufficient (insufficient MACE reduction benefit).

Clinical Trial

NCTID
NCT05142722
Acronym
BROADWAY
Drug Name
Obicetrapib
Drug MoA
selective CETP inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Atherosclerotic Cardiovascular Disease (ASCVD) / Heterozygous familial hypercholesterolemia (HeFH)
Human Patients
2532
Sponsor
NewAmsterdam Pharma
Phase
Phase 3

Prediction of , index 1012

Prospective Prediction
Prediction Index
1012
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit of obicetrapib in MACE or cardiovascular hospitalization with significantly increased toxicity-driven mortality)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit of obicetrapib in MACE or cardiovascular hospitalization with significantly increased toxicity-driven mortality)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
212 days in advance
Readout Data Interpretation
obicetrapib + SoC did not achieve statistical significance in MACE reduction compared with SoC alone (0.79 HR)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant (insignificant MACE reduction benefit) and commercially insufficient (insufficient MACE reduction benefit)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10mg Obicetrapib in Participants With HeFH and/or ASCVD Who Are Not Adequately Controlled by Their Lipid Modifying Therapies
Phase
Phase 3
Status
Completed
Enrollment
2530
Lead sponsor
NewAmsterdam Pharma
Conditions
Dyslipidemias; High Cholesterol; Hypercholesterolemia; Familial Hypercholesterolemia; Atherosclerotic Cardiovascular Disease
Interventions
DRUG: Placebo; DRUG: Obicetrapib
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-12-15
Primary completion
2024-09-26
Completion
2024-09-26
Results first posted
2025-09-19
Primary outcomes
  • Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC] (84 Days)

NCT05142722 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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