MOSAIC - A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Selonsertib in Subjects With Moderate to Advanced Diabetic Kidney Disease
MOSAIC - A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Selonsertib in Subjects With Moderate to Advanced Diabetic Kidney Disease
The primary objective of this study is to evaluate whether selonsertib (SEL) can slow the decline in kidney function in participants with moderate to advanced diabetic kidney disease (DKD).
Following the screening period, eligible participants will enroll into a Run-in period of at least 5 weeks and receive placebo to match SEL for at least 1 week and then SEL for at least 4 weeks. After completing Run-in period, eligible participants will be randomized and receive either SEL or placebo to match SEL for at least 48 weeks.
Key Inclusion Criteria:
Diagnosis of type 2 diabetes mellitus (T2DM) as per local guidelines.
Estimated glomerular filtration rate (eGFR) value calculated by central laboratory utilizing samples collected during screening and prior to enrollment of ≥ 20 mL/min/1.73 m^2 to < 60 mL/min/1.73 m^2 with albuminuria
eGFR and urine albumin to creatinine ratio (UACR) must meet criteria a, b, or c
Treatment with either an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB)
Individuals already receiving sodium-glucose co-transporter-2 (SGLT-2) inhibitors must be on a stable dose for at least 2 weeks prior to enrollment
Mean systolic blood pressure (SBP) must be <160 mmHg and mean diastolic blood pressure (DBP) must be <100 mmHg
Required baseline laboratory data, analyzed by central laboratory, within 30 days prior to enrollment
Key Exclusion Criteria:
Hemoglobin A1c (HbA1c) > 12.0% within 30 days prior to enrollment
Individuals with diagnosis of type 1 diabetes mellitus (T1DM) or maturity onset diabetes of the young (MODY)
Body mass index (BMI) > 50 kg/m^2
UACR > 5000 mg/g on any measurement during screening
End stage kidney disease (ESKD) (i.e., chronic hemodialysis, chronic peritoneal dialysis, or history of kidney transplantation)
Anticipated progression to ESKD (need for chronic hemodialysis, chronic peritoneal dialysis or receipt of kidney transplant) within 3 months after enrollment
Unstable cardiovascular disease
Pregnant or lactating females or planning to become pregnant or breastfeed during the study
Concurrent use of either
Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the individual or impair the assessment of study results
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Port Charlotte, Florida 33952, United States
Troy, Michigan 48098, United States
Statesville, North Carolina 28625, United States
Kitakyushu-shi, 802-8555, Japan
Kurume-shi, 830-0011, Japan
Saitama-shi, 338-0837, Japan
Sanuki-shi, 769-2393, Japan
Tachikawa-shi, 190-8531, Japan
Toyota-shi, 471-8513, Japan