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NCT05425745 (Obicetrapib in Heterozygous Familial Hypercholesterolemia): BVCT ex-ante prediction vs. reported outcome

On 12 May 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 29 Jul 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant yet commercially insufficient.

Clinical Trial

NCTID
NCT05425745
Acronym
BROOKLYN
Drug Name
Obicetrapib
Drug MoA
selective CETP inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Heterozygous Familial Hypercholesterolemia (HeFH)
Human Patients
354
Sponsor
NewAmsterdam Pharma
Phase
Phase 2

Prediction of , index 1011

Prospective Prediction
Prediction Index
1011
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
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit of obicetrapib in LDL-C reduction with significantly increased toxicity-driven mortality)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
78 days in advance
Readout Data Interpretation
safe yet with 41.5% LDL-C reduction by Day 364 which is weaker than the market expected 50% LDL-C reduction.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet commercially insufficient
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 10 mg Obicetrapib in Participants With a History of HeFH Who Are Not Adequately Controlled by Their Lipid Modifying Therapies
Phase
Phase 3
Status
Completed
Enrollment
354
Lead sponsor
NewAmsterdam Pharma
Conditions
Dyslipidemias; High Cholesterol; Hypercholesterolemia; Familial Hypercholesterolemia; Lipid Metabolism Disorder; Metabolic Disease; Lipid Metabolism, Inborn Errors; Genetic Disease, Inborn; Hyperlipoproteinemias
Interventions
DRUG: Obicetrapib; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-07-25
Primary completion
2024-05-28
Completion
2024-05-28
Results first posted
2025-06-11
Primary outcomes
  • Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC] (84 Days)

NCT05425745 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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