Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS ANGPTL3-LRx in Healthy Volunteers With Elevated Triglycerides and Participants With Familial Hypercholesterolemia

Phase 1 Completed 48 enrolled Ionis Pharmaceuticals, Inc. Akcea Therapeutics · collab

RandomizedParallel-groupDouble-blindOther

Summary

The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS ANGPTL3-LRx (ISIS 703802) given to healthy volunteer subjects with elevated triglycerides and subjects with familial hypercholesterolemia.

Timeline

Start: 2015-11-30
Primary completion: 2017-04-12
Completion: 2017-06-26

Publications

Graham MJ, Lee RG, Brandt TA, Tai LJ, Fu W, Peralta R, Yu R, Hurh E, Paz E, McEvoy BW, Baker BF, Pham NC, Digenio A, Hughes SG, Geary RS, Witztum JL, Crooke RM, Tsimikas S. Cardiovascular and Metabolic Effects of ANGPTL3 Antisense Oligonucleotides. N Engl J Med. 2017 Jul 20;377(3):222-232. doi: 10.1056/NEJMoa1701329. Epub 2017 May 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IONIS ANGPTL3-LRx	Antisense oligonucleotide	10 mg	Subcutaneous
Subject	IONIS ANGPTL3-LRx	Antisense oligonucleotide	20 mg	Subcutaneous
Subject	IONIS ANGPTL3-LRx	Antisense oligonucleotide	40 mg	Subcutaneous
Subject	IONIS ANGPTL3-LRx	Antisense oligonucleotide	60 mg	Subcutaneous
Subject	IONIS ANGPTL3-LRx	Antisense oligonucleotide	80 mg	Subcutaneous
Subject	IONIS ANGPTL3-LRx	Antisense oligonucleotide	120 mg	Subcutaneous

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS ANGPTL3-LRx in Healthy Volunteers With Elevated Triglycerides and Participants With Familial Hypercholesterolemia

Summary

Timeline

Publications

Drugs

Indications