FRAZIER LIFESCIENCES ACQUISITION CORPORATION NewAmsterdam Pharma Company N.V. announced the completion of patient enrollment in the pivotal Phase 3 TANDEM clinical trial evaluating the fixed-dose combination of obicetrapib plus ezetimibe in adult patients with Heterozygous Familial Hypercholesterolemia and/or Atherosclerotic Cardiovascular Disease or multiple risk factors for ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies. The double-blind, placebo-controlled Phase 3 TANDEM clinical trial enrolled 407 patients with HeFH and/or ASCVD or ASCVD risk equivalents, who have a baseline LDL-C of at least 70 mg/dL. The primary objective of the placebo-controlled, double-blind, four-arm, randomized TANDEM trial is to evaluate the effect of 10 mg obicetrapib and 10 mg ezetimibe FDC on the change in LDL-C levels from baseline, compared to both ezetimibe 10 mg and obicetrapib 10 mg monotherapy and to placebo.
Secondary objectives include evaluating the effect of the FDC on lipoprotein(a) (?Lp(a)?), apolipoprotein B (?ApoB?) and non-high-density lipoprotein cholesterol. The trial will also evaluate the safety and tolerability profile of the FDC.
