Safety and Tolerability of Varying Load and Dose of ISIS 301012 in People With Elevated LDL-cholesterol Levels

Phase 2 Completed 50 enrolled Kastle Therapeutics, LLC Ionis Pharmaceuticals · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of this study is to assess the safety and tolerability of varying dose and load regimens of ISIS 301012 in people who have elevated LDL-cholesterol levels.

Timeline

Start: 2005-08
Primary completion: 2007-03
Completion: 2007-08

Publications

Akdim F, Tribble DL, Flaim JD, Yu R, Su J, Geary RS, Baker BF, Fuhr R, Wedel MK, Kastelein JJ. Efficacy of apolipoprotein B synthesis inhibition in subjects with mild-to-moderate hyperlipidaemia. Eur Heart J. 2011 Nov;32(21):2650-9. doi: 10.1093/eurheartj/ehr148. Epub 2011 May 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	mipomersen	Antisense oligonucleotide	100 mg	Subcutaneous
Subject	mipomersen	Antisense oligonucleotide	200 mg	Subcutaneous
Subject	mipomersen	Antisense oligonucleotide	300 mg	Subcutaneous
Subject	mipomersen	Antisense oligonucleotide	400 mg	Subcutaneous

Safety and Tolerability of Varying Load and Dose of ISIS 301012 in People With Elevated LDL-cholesterol Levels

Summary

Timeline

Publications

Drugs

Indications