Phase 3
Completed N=407
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
Source: ClinicalTrials.gov NCT06005597 ↗Enrolled (actual)
407
Serious AEs
4.9%
Results posted
Oct 2025
Primary outcomePrimary: Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C — -45.58; 3.03 percent change from baseline — p=<.0001
◆ Published Evidence
Established
50citations · ~50 / year
Fixed-dose combination of obicetrapib and ezetimibe for LDL cholesterol reduction (TANDEM): a phase 3, randomised, double-blind, placebo-controlled trial.
Summary
The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.
Linked Publications
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Fixed-dose combination of obicetrapib and ezetimibe for LDL cholesterol reduction (TANDEM): a phase 3, randomised, double-blind, placebo-controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C |
-45.58; 3.03 | <.0001 sig |
| PRIMARY Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C |
-45.58; -17.63 | <.0001 sig |
| PRIMARY Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C |
-45.58; -28.82 | 0.0007 sig |
| PRIMARY Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C |
-28.82; 3.03 | <.0001 sig |
| SECONDARY Effect of Fixed Dose Combination (FDC) Compared to Placebo on Non-HDL-C |
-42.42; 2.71 | <.0001 sig |
| SECONDARY Effect of Fixed Dose Combination (FDC) Compared to Placebo on Apolipoprotein B (ApoB) |
-26.91; 2.28 | <.0001 sig |
| SECONDARY Effect of Obicetrapib Monotherapy Compared to Placebo on Non-HDL-C |
-27.19; 2.71 | <.0001 sig |
| SECONDARY Effect of Obicetrapib Monotherapy Compared to Placebo on Apolipoprotein B (ApoB) |
-17.50; 2.28 | <.0001 sig |
| SECONDARY Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Non-HDL-C |
-42.42; -16.98 | <.0001 sig |
| SECONDARY Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Apolipoprotein B (ApoB) |
-26.91; -12.71 | <.0001 sig |
| SECONDARY Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Non-HDL-C |
-42.42; -27.19 | 0.0003 sig |
| SECONDARY Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Apolipoprotein B (ApoB) |
-26.91; -17.50 | 0.007 sig |
Eligibility Criteria
Inclusion Criteria
- Have underlying HeFH and/or a history of ASCVD or multiple ASCVD risk factors
- On maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestyle modifications
- LDL-C ≥ 70 mg/dL
- Triglycerides 1.5 x upper limit of normal (ULN)
- History of malignancy
- Creatinine kinase (CK) >3 X ULN
- Alcohol abuse
- Treatment with investigational product
- Treatment with gemfibrozil or ezetimibe
- Previous participation in a trial evaluating obicetrapib
- Known allergy to study drugs, placebo or excipients in study drugs of placebo
- Other condition that would interfere with the conduct of the study
Data sourced from ClinicalTrials.gov (NCT06005597) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.