A Phase 2, Double-Blind, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GS-4997 in Subjects With Diabetic Kidney Disease
A Phase 2, Double-Blind, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GS-4997 in Subjects With Diabetic Kidney Disease
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.
Key Inclusion Criteria:
Adult male or females with prior diagnosis of Diabetic Kidney Disease
Type 2 diabetes mellitus diagnosis for at least 6 months
eGFR (MDRD) at screening ≥ 15 mL/min/1.73m^2 to < 60 mL/min/1.73m^2
Urine albumin to creatinine ratio (UACR) as follows:
Receiving angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blockers (ARB) at a minimum dose deemed appropriate for the individual by the investigator and be at a stable dose for the last three months
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Miami, Florida 33173, United States
Butte, Montana 59701, United States
Voorhees Township, New Jersey 08043, United States