Prevention & lipidsRandomised controlled trial
Fixed-dose combination of obicetrapib and ezetimibe for LDL cholesterol reduction (TANDEM): a phase 3, randomised, double-blind, placebo-controlled trial
- Randomised controlled trial
- phase 3
- double-blind
- placebo-controlled
- 48 US sites
Authors' conclusion
Combination therapy of obicetrapib and ezetimibe significantly reduced LDL cholesterol.
Study context
- Population
- Adults with pre-existing or high risk for atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolaemia, LDL-C ≥1.8 mmol/L (70 mg/dL) despite maximally tolerated lipid-lowering therapy excluding ezetimibe, or statin intolerance
- Participants
- 407 adults
- Comparison
- Obicetrapib + ezetimibe fixed-dose combination (FDC) vs obicetrapib, ezetimibe or placebo
- FDCn = 102
- Obicetrapibn = 102
- Ezetimiben = 101
- Placebon = 102reference
- Primary endpoint
- Co-primary: percent LDL-C change with FDC vs placebo, ezetimibe and obicetrapib, and placebo-adjusted change with obicetrapib monotherapy
- Follow-up
- Day 84
Primary result
As reported in the abstract
Percent LDL-C change
Estimate
FDC vs Placebo
percent difference −48.6 %(95% CI −58.3 to −38.9)
FDC vs Ezetimibe
percent difference −27.9 %(95% CI −37.5 to −18.4)
FDC vs Obicetrapib
percent difference −16.8 %(95% CI −26.4 to −7.1)
Obicetrapib vs Placebo
decrease 31.9 %(CI 22.1–41.6)
Further findings
| Outcome | FDC | Obicetrapib | Ezetimibe | Placebo |
|---|---|---|---|---|
| Deaths | 1% | 1% | 1% | 0 events |
Safety
Adverse events
Serious adverse events
Original publication
Fixed-dose combination of obicetrapib and ezetimibe for LDL cholesterol reduction (TANDEM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. Published 7 May 2025. doi:10.1016/s0140-6736(25)00721-4
Summarised from the published abstract; every number is checked against it