Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia

Summary

The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite receiving maximally-tolerated LMT. Persistent hypercholesterolemia is defined as LDL-C ≥70 mg/dL (1.81 mmol/L) for those patients with clinical ASCVD and LDL-C ≥100 mg/dL (2.59 mmol/L) for those patients without clinical ASCVD.

Timeline

Start

2017-11-10

Primary completion

2020-05-22

Completion

2020-12-14

Outcome

Met primary endpoint

registry Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC Q2W (DBTP); p < .0001 NCT03175367 ↗

registry Least Squares Mean Difference -38.5 (95% CI -56.5 to -20.6); Mixed Models Analysis NCT03175367 ↗

paper were -56.0, -52.9, and -38.5 percentage points, respectively (P<0.001 for all comparisons). PMID 33196153 ↗

Publications

• Rosenson RS, Burgess LJ, Ebenbichler CF, Baum SJ, Stroes ESG, Ali S, Khilla N, McGinniss J, Gaudet D, Pordy R. Longer-Term Efficacy and Safety of Evinacumab in Patients With Refractory Hypercholesterolemia. JAMA Cardiol. 2023 Nov 1;8(11):1070-1076. doi: 10.1001/jamacardio.2023.2921.
• Rosenson RS, Burgess LJ, Ebenbichler CF, Baum SJ, Stroes ESG, Ali S, Khilla N, Hamlin R, Pordy R, Dong Y, Son V, Gaudet D. Evinacumab in Patients with Refractory Hypercholesterolemia. N Engl J Med. 2020 Dec 10;383(24):2307-2319. doi: 10.1056/NEJMoa2031049. Epub 2020 Nov 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evinacumab	Monoclonal antibody	5 mg/kg	Subcutaneous
Subject	Evinacumab	Monoclonal antibody	15 mg/kg	Subcutaneous
Subject	Evinacumab	Monoclonal antibody	300 mg	Subcutaneous
Subject	Evinacumab	Monoclonal antibody	450 mg	Subcutaneous

Indications