Obicetrapib+
Ezetimibe
Combination Therapy
NewAmsterdam Pharma is studying obicetrapib, a highly selective cholesteryl ester
transfer protein (CETP) inhibitor, with ezetimibe, an NPC1L1 inhibitor that blocks
intestinal reabsorption of cholesterol, as a fixed-dose combination in patients with
atherosclerotic cardiovascular disease (ASCVD), heterozygous familial
hypercholesterolemia (HeFH), or those who are CV risk equivalent, to be used alongside
maximally tolerated lipid-lowering therapies.1-3
Ongoing Combination Programs
PHASE 1
PHASE 2
PHASE 3
Cardiovascular Disease
TANDEM (NCT06005597) is a placebo-controlled, double-blind, randomized, Phase 3 study in participants with ASCVD and/or multiple ASCVD risk factors, or HeFH. It is designed to evaluate the efficacy, safety, and tolerability of obicetrapib and ezetimibe fixed-dose combination alongside diet and maximally tolerated lipid-lowering therapy.1
Primary objective: Evaluate the effect on LDL-C levels, compared with both ezetimibe and obicetrapib monotherapy, and to placebo.
Secondary objectives: Evaluate the effect on apolipoprotein B (ApoB) and non-high-density lipoprotein cholesterol (non-HDL-C) levels.
Topline results: Observed an LS mean LDL-C reduction of 50% (p < 0.0001) in the obicetrapib and ezetimibe fixed-dose combination compared with placebo at day 84, with more than 70% of patients achieving LDL-C levels below 55 mg/dL.
REMBRANDT (NCT06305559) is a placebo-controlled, double-blind, randomized, Phase 3 cardiovascular computed tomography angiography (CCTA) imaging trial. It is designed to assess the impact of obicetrapib and ezetimibe fixed-dose combination on coronary plaque and inflammation in adults with high-risk ASCVD who are not adequately controlled by their maximally tolerated lipid-modifying therapy.2
Primary objective: Evaluate the effect of obicetrapib 10 mg and ezetimibe 10 mg daily fixed dose combination (FDC) on total non-calcified coronary atherosclerotic plaque volume (NCPV) at 18 months.
Secondary objective: Evaluate obicetrapib 10mg and ezetimibe 10 mg daily FDC therapy’s effect on the percent change from baseline to 18 months in LDL-C levels and in total NCPV as compared to placebo.
Completed Programs
PHASE 1
PHASE 2
PHASE 3
Cardiovascular Disease
ROSE2 (NCT05266586) was designed as a placebo-controlled, double-blind, randomized, Phase 2 clinical trial evaluating the efficacy, safety, and tolerability of obicetrapib, in combination with ezetimibe and as monotherapy, alongside high-intensity statin therapy.3
Topline results: In ROSE2, obicetrapib plus ezetamibe combination therapy resulted in more than 87% of patients achieving LDL-C threshold levels of <55mg/dL versus 42% of patients treated with obicetrapib monotherapy and 0% of patients treated with placebo.
Expanded Access
1. ClinicalTrials.gov. Study of obicetrapib & ezetimibe fixed dose combination on top of maximum tolerated lipid-modifying therapies (TANDEM). NCT06005597. Last updated March 12, 2024. Accessed March 19, 2024. https://clinicaltrials.gov/study/NCT06005597 2. ClinicalTrials.gov. A CCTA imaging trial to evaluate the effect of obicetrapib/ezetimibe on coronary plaque (REMBRANDT). NCT06305559. Last updated March 12, 2024. Accessed March 19, 2024. https://clinicaltrials.gov/study/NCT06305559 3. ClinicalTrials.gov. Study to evaluate the effect of obicetrapib in combination with ezetimibe as an adjunct to HIS therapy (ROSE2). NCT05266586. Last updated July 3, 2024. Accessed July 21, 2024. https://clinicaltrials.gov/study/NCT05266586