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NCT06005597 (obicetrapib in familial hypercholesterolemia and/or atherosclerotic cardiovascular disease): 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 20 Nov 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant yet weak and commercially TBD (no MACE data available).

Clinical Trial

Acronym
TANDEM
Drug Name
obicetrapib
Drug MoA
selective CETP inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD)
Human Patients
407
Sponsor
NewAmsterdam Pharma
Phase
Phase 3

Prediction of , index 1596

Prospective Prediction
Prediction Index
1596
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit of obicetrapib in MACE with significantly increased toxicity-driven mortality; The MACE-based clinical benefit of obicetrapib + ezetimibe + SoC is inferior to that of SoC + ezetimibe or SoC alone)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit of obicetrapib in LDL-C reduction)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
192 days in advance
Readout Data Interpretation
obicetrapib + ezetimibe + SoC achieved 48.6% LDL-C reduction at day 84; which is superior to ezetimibe + SoC or SoC alone (yet weaker than 54-59% reduction as the market consensus for strong efficacy); obicetrapib achieved 7% TEAE; which is inferior to ezetimibe + SoC (3%) or SoC alone (4%)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet weak and commercially TBD (no MACE data available)
Prediction Classification
True Positive (TP)

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 Obicetrapib 10 mg and Ezetimibe 10 mg Fixed Dose Combination Daily on Top of Maximally Tolerated Lipid-Modifying Therapy in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) or Multiple ASCVD Risk Factors
Phase
Phase 3
Status
Completed
Enrollment
407
Lead sponsor
NewAmsterdam Pharma
Conditions
Dyslipidemias; Hypercholesterolemia; Familial Hypercholesterolemia; ASCVD; High Cholesterol
Interventions
COMBINATION_PRODUCT: Combination Therapy; DRUG: Monotherapy obicetrapib; DRUG: Monotherapy ezetimibe; OTHER: Combination Therapy placebo; OTHER: Obicetrapib Placebo; OTHER: Ezetimibe Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-03-01
Primary completion
2024-09-25
Completion
2024-10-16
Results first posted
2025-10-08
Primary outcomes
  • Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C (84 Days)
  • Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C (84 Days)
  • Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C (84 Days)
  • Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C (84 Days)

NCT06005597 on ClinicalTrials.gov

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