Diabetic Kidney Disease (DKD)
Conditions
Keywords
Chronic Kidney Disease (CKD), Type 2 Diabetes, Lipid Management
Brief 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
Interventions
DRUGALN-ANG3
Administered per the protocol
DRUGEvinacumab
Administered per the protocol
DRUGALN-ANG3 placebo
Administered per the protocol
DRUGEvinacumab placebo
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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 disease 2. Renal disease that required treatment with systemic immunosuppressive therapy, or a history of dialysis or renal transplant 3. Medically unstable as assessed by the investigator 4. Hospitalization (ie, \>24 hours) within 30 days of the screening visit NOTE: Other Protocol-Defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in Urine Albumin to Creatinine Ratio (UACR) | Baseline to Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Estimated Glomerular Filtration Rate (eGFR) | Baseline to Week 24 |
| Change in total cholesterol | Baseline to Week 24 |
| Change in Low-Density Lipoprotein-Cholesterol (LDL-C) | Baseline to Week 24 |
| Change in High-Density Lipoprotein-Cholesterol (HDL-C) | Baseline to Week 24 |
| Change in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) | Baseline to Week 24 |
| Change in triglycerides | Baseline to Week 24 |
| Change in Apolipoprotein B (ApoB) | Baseline to Week 24 |
| Concentration of combined ALN-ANG3 and metabolite(s) and evinacumab | Up to Week 24 |
| Change in concentration of Angiopoietin-Like Protein-3 (ANGPTL-3) | Baseline to Week 24 |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Up to Week 48 |
| Severity of TEAEs | Up to Week 48 |
| Incidence of ADAs to ALN-ANG3 | Through Week 24 |
| Magnitude of ADAs to ALN-ANG3 | Through Week 24 |
| Incidence of ADAs to evinacumab | Through Week 24 |
| Magnitude of ADAs to evinacumab | Through Week 24 |
Countries
United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed