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Recruiting
NCT07271186
Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease
Conditions: Diabetic Kidney Disease (DKD)
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 270
Sponsor: Regeneron Pharmaceuticals
Location: Apogee Clinical Research, LLC Huntsville Alabama
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 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/Exclusion Criteria Apply
Source: ClinicalTrials.gov (NCT07271186). StuddyBuddy aggregates publicly available trial information.