Menarini Group announces Positive Topline Data from Pivotal Phase 3 BROADWAY & TANDEM Clinical Trials Evaluating Obicetrapib and the Fixed-Dose Combination Obicetrapib with Ezetimibe 10 mg | PR Newswire [Video]

– Both pivotal studies achieved primary endpoints of LS mean reduction in LDL-C on top of maximally tolerated lipid-modifying therapies with high statistical significance (p<0.0001)

– Approximately 50% of patients in BROADWAY (Obicetrapib monotherapy) and over 70% of patients in TANDEM (Fixed Dose Combination Obicetrapib with Ezetimibe) achieved LDL-C target below 55 mg/dL

– In BROADWAY a 21% reduction in major adverse cardiovascular events favoring Obicetrapib was observed at one year

— In both studies, Obicetrapib monotherapy and the fixed dose combination with Ezetimibe were shown to be well tolerated 

, /PRNewswire/ — Menarini Group today announces positive topline data from the Phase 3 BROADWAY (NCT05142722) and the Phase 3 TANDEM (NCT06005597) clinical trials sponsored by NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for …