NewAmsterdam Pharma doses first patient in Phase 3 TANDEM trial

NewAmsterdam Pharma announced the dosing of the first patient and initiation of TANDEM, a pivotal Phase 3 clinical trial to evaluate obicetrapib and ezetimibe FDC 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 primary objective of the placebo-controlled, double-blind, four-arm, randomized TANDEM trial is to evaluate the effect of 10mg obicetrapib and 10mg ezetimibe FDC on LDL-C levels, compared to both ezetimibe 10mg and obicetrapib 10mg monotherapy and to placebo. Secondary objectives include evaluating the effect of the FDC on apolipoprotein B and non-high-density lipoprotein cholesterol. The trial will also evaluate the safety and tolerability profile of the FDC. NewAmsterdam anticipates enrolling approximately 400 patients on maximally tolerated lipid-modifying therapies with HeFH, ASCVD or ASCVD risk equivalents and who have a baseline LDL-C of at least 70 mg/Dl. Patients will be randomized to one of the following groups: placebo, 10 mg obicetrapib, 10mg ezetimibe, or obicetrapib 10mg and ezetimibe 10mg FDC tablet, all groups dosed as a once-daily oral treatment for an 84-day treatment period. HeFH is an inherited genetic disorder that causes dangerously high cholesterol levels. Patients with ASCVD have established cardiovascular diseases characterized by the buildup of plaque in the arteries, including coronary artery stenosis, myocardial infarction or stroke. Patients who have multiple risk factors for ASCVD are at high risk of experiencing a cardiovascular event in the near future.