Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease

Summary

The primary objective of this study is to determine the effect of selonsertib (formerly GS-4997) on estimated glomerular filtration rate (eGFR) decline in participants with diabetic kidney disease (DKD). Participants will be randomized with a 1:1:1:1 allocation to receive 1 of 3 doses of selonsertib (2 mg, 6 mg, or 18 mg) or matching placebo.

Timeline

Start

2014-06

Primary completion

2016-07

Completion

2016-08

Outcome

Missed primary endpoint

paper Although the trial did not meet its primary endpoint PMID 31506292 ↗

release “a Phase 2 study in DKD did not achieve its primary endpoint based on a preliminary analysis.” gilead.com ↗

Publications

• Results Chertow GM, Pergola PE, Chen F, Kirby BJ, Sundy JS, Patel UD; GS-US-223-1015 Investigators. Effects of Selonsertib in Patients with Diabetic Kidney Disease. J Am Soc Nephrol. 2019 Oct;30(10):1980-1990. doi: 10.1681/ASN.2018121231. Epub 2019 Sep 10.
• Tesch GH, Ma FY, Han Y, Liles JT, Breckenridge DG, Nikolic-Paterson DJ. ASK1 Inhibitor Halts Progression of Diabetic Nephropathy in Nos3-Deficient Mice. Diabetes. 2015 Nov;64(11):3903-13. doi: 10.2337/db15-0384. Epub 2015 Jul 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Selonsertib	Small molecule	2 mg	Oral
Subject	Selonsertib	Small molecule	6 mg	Oral
Subject	Selonsertib	Small molecule	18 mg	Oral

Indications