A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of ANGPTL3 Inhibition With Either Small-Interfering RNA Alone or in Combination With an ANGPTL3 Antibody in Participants With Diabetic Kidney Disease

Regeneron Pharmaceuticals

Summary

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

Eligibility

Age range: 18–80 years
Sex: All
Healthy volunteers: No

Detailed criteria

Key Inclusion Criteria: 1. Medical history of type 2 diabetes and receiving medical therapy or lifestyle interventions for glucose management 2. Hemoglobin A1C (HbA1c) of 6.5 to 10% at screening 3. eGFR 30 to 90 mL/min/1.73 m\^2 using 2021 Chronic Kidney Disease-Epidemiology Collaboration-Estimated Glomerular Filtration Rate using Creatinine and Cystatin C (CKD-EPI eGFRcr-cys) equation at screening 4. Albuminuria: Urine Albumin to Creatinine Ratio (UACR) of 500 to 5000 mg/g at screening Key Exclusion Criteria: 1. Known medical history or clinical evidence indicative of non-diabetic renal di…

Interventions

Drug
ALN-ANG3
Administered per the protocol
Drug
Evinacumab
Administered per the protocol
Drug
ALN-ANG3 placebo
Administered per the protocol
Drug
Evinacumab placebo
Administered per the protocol

Locations (47)

Apogee Clinical Research, LLC
Huntsville, Alabama
Applied Research Center of Arkansas
Little Rock, Arkansas
AME Clinical Research
Huntington Beach, California
Amicis Research Center
Northridge, California
FOMAT - Vista del Mar Medical Group
Oxnard, California
Central Coast Nephrology
Salinas, California