Safety, Tolerability, and Pharmacodynamics of IONIS-DGAT2Rx in Adult Patients With Type 2 Diabetes

Summary

The purpose is to assess the Safety, Tolerability, and Pharmacodynamics effect of IONIS DGAT2Rx in up to 45 Adult Patients with Type 2 Diabetes.

Timeline

Start

2017-11-03

Primary completion

2018-11-28

Completion

2018-11-28

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs IONIS DGAT2Rx 250 mg; p = 0.003; ANOVA NCT03334214 ↗

registry analysis (superiority test); Placebo vs IONIS DGAT2Rx 250 mg; p = 0.026; ANOVA NCT03334214 ↗

Publications

• Loomba R, Morgan E, Watts L, Xia S, Hannan LA, Geary RS, Baker BF, Bhanot S. Novel antisense inhibition of diacylglycerol O-acyltransferase 2 for treatment of non-alcoholic fatty liver disease: a multicentre, double-blind, randomised, placebo-controlled phase 2 trial. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):829-838. doi: 10.1016/S2468-1253(20)30186-2. Epub 2020 Jun 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IONIS DGAT2Rx	Antisense oligonucleotide	250 mg	Subcutaneous

Indications