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

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:

- Stage/Stratum 3a: eGFR range 45 to < 60 mL/min; UACR ≥ 600 mg/g

- Stage/Stratum 3b: eGFR range 30 to < 45 mL/min; UACR ≥ 300 mg/g

- Stage/Stratum 4: eGFR range 15 to < 30 mL/min; UACR ≥ 150 mg/g

- 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 o Individuals not on
ACEi/ARB may be screened if there is documented intolerance to ACE inhibitor and/or
ARB

Key Exclusion Criteria:

- Type 1 diabetes mellitus

- Non-diabetic kidney disease

- UACR > 5000 mg/g on any measurement during screening

- End stage renal disease (ESRD; receiving peritoneal dialysis, hemodialysis, or status
post renal transplantation) or anticipated to occur within the treatment period

- Anticipated progression to ESRD (need for dialysis or listing for renal
transplantation) within the study treatment period

- Unstable cardiovascular disease

- Immunosuppressive drugs

- Pregnant or lactating females

Note: Other protocol defined Inclusion/Exclusion criteria may apply.