Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C

NCT03531905 ↗

Phase 2 Completed 242 enrolled Esperion Therapeutics, Inc.

RandomizedFactorialTriple-blindTreatment

Summary

12 week study to assess the LDL-C lowering efficacy, other lipid and glycemic measures, and safety of bempedoic acid/ezetimibe FDC compared to ezetimibe and placebo in patients with type 2 diabetes (T2D) and elevated LDL-C

Timeline

Start: 2018-05-09
Primary completion: 2019-06-18
Completion: 2019-06-18

Outcome

Met primary endpoint

registry analysis (superiority test); Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Placebo; p <0.001; Difference of Least Squares (LS) means -39.6 (95% CI -45.8 to -33.4); ANCOVA NCT03531905 ↗

release “The 12-week study met its primary endpoints as well as key secondary endpoints” esperion.com ↗

release “in the Phase 2 (1002-058) study, NEXLIZET significantly lowered LDL-Cholesterol (LDL-C) by a mean 40% compared to placebo” esperion.com ↗

Publications

Background Gutierrez MJ, Rosenberg NL, Macdougall DE, Hanselman JC, Margulies JR, Strange P, Milad MA, McBride SJ, Newton RS. Efficacy and safety of ETC-1002, a novel investigational low-density lipoprotein-cholesterol-lowering therapy for the treatment of patients with hypercholesterolemia and type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2014 Mar;34(3):676-83. doi: 10.1161/ATVBAHA.113.302677. Epub 2014 Jan 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bempedoic acid	Small molecule	180 mg	Oral
Comparator	Ezetimibe	Unknown	10 mg	Oral