This study is researching experimental drugs called ALN-ANG3 and evinacumab (called "study drugs"). The study is focused on participants who have diabetic kidney disease. The aim of the study is to see how safe and effective the study drugs are. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
270
Administered per the protocol
Administered per the protocol
Administered per the protocol
Administered per the protocol
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
RECRUITINGAmicis Research Center
Northridge, California, United States
RECRUITINGFOMAT - Vista del Mar Medical Group
Oxnard, California, United States
RECRUITINGCentral Coast Nephrology
Salinas, California, United States
Percent change in Urine Albumin to Creatinine Ratio (UACR)
Time frame: Baseline to Week 24
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline to Week 24
Change in total cholesterol
Time frame: Baseline to Week 24
Change in Low-Density Lipoprotein-Cholesterol (LDL-C)
Time frame: Baseline to Week 24
Change in High-Density Lipoprotein-Cholesterol (HDL-C)
Time frame: Baseline to Week 24
Change in non-High-Density Lipoprotein-Cholesterol (non-HDL-C)
Time frame: Baseline to Week 24
Change in triglycerides
Time frame: Baseline to Week 24
Change in Apolipoprotein B (ApoB)
Time frame: Baseline to Week 24
Concentration of combined ALN-ANG3 and metabolite(s) and evinacumab
Time frame: Up to Week 24
Change in concentration of Angiopoietin-Like Protein-3 (ANGPTL-3)
Time frame: Baseline to Week 24
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 48
Severity of TEAEs
Time frame: Up to Week 48
Incidence of ADAs to ALN-ANG3
Time frame: Through Week 24
Magnitude of ADAs to ALN-ANG3
Time frame: Through Week 24
Incidence of ADAs to evinacumab
Time frame: Through Week 24
Magnitude of ADAs to evinacumab
Time frame: Through Week 24
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North America Research Institute
San Dimas, California, United States
RECRUITINGAmicis Research Center
Santa Clarita, California, United States
RECRUITINGAmicis Research Center
Valencia, California, United States
RECRUITINGNational Institute of Clinical Research, Inc.
Victorville, California, United States
RECRUITINGD&H Doral Research Center
Doral, Florida, United States
RECRUITINGAGA Clinical Trials
Hialeah, Florida, United States
RECRUITING...and 29 more locations