ApoA-I Synthesis Stimulation and Intravascular Ultrasound for Coronary Atheroma Regression Evaluation

Phase 2 Completed 324 enrolled Resverlogix Corp The Cleveland Clinic · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This study is designed to characterize the early effects of ApoA-I synthesis with RVX000222 on coronary atherosclerotic disease when administered to patients with coronary artery disease and have a low HDL-C level, as assessed by Intravascular Ultrasound (IVUS) in addition to standard background therapy.

Timeline

Start: 2011-09
Primary completion: 2013-05
Completion: 2013-06

Outcome

Missed primary endpoint

paper between groups P = 0.81. PMID 26385396 ↗

paper showed no greater increase in apoA-I or HDL-C or incremental regression of atherosclerosis than administration of placebo. PMID 26385396 ↗

Publications

Nicholls SJ, Puri R, Wolski K, Ballantyne CM, Barter PJ, Brewer HB, Kastelein JJ, Hu B, Uno K, Kataoka Y, Herrman JP, Merkely B, Borgman M, Nissen SE. Effect of the BET Protein Inhibitor, RVX-208, on Progression of Coronary Atherosclerosis: Results of the Phase 2b, Randomized, Double-Blind, Multicenter, ASSURE Trial. Am J Cardiovasc Drugs. 2016 Feb;16(1):55-65. doi: 10.1007/s40256-015-0146-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apabetalone	Small molecule	200 mg	—