Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRegeneron Pharmaceuticals

About this trial

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

Qualifiers

Medical history of type 2 diabetes and receiving medical therapy or lifestyle interventions for glucose management

Hemoglobin A1C (HbA1c) of 6.5 to 10% at screening

eGFR 30 to 90 mL/min/1.73 m² using 2021 Chronic Kidney Disease-Epidemiology Collaboration-Estimated Glomerular Filtration Rate using Creatinine and Cystatin C (CKD-EPI eGFRcr-cys) equation at screening

Albuminuria: Urine Albumin to Creatinine Ratio (UACR) of 500 to 5000 mg/g at screening

Disqualifiers

Known medical history or clinical evidence indicative of non-diabetic renal disease

Renal disease that required treatment with systemic immunosuppressive therapy, or a history of dialysis or renal transplant

Medically unstable as assessed by the investigator

Hospitalization (ie, >24 hours) within 30 days of the screening visit

Trial design

Treatments tested in this trial

  • ALN-ANG3
  • Evinacumab
  • ALN-ANG3 placebo
  • Evinacumab placebo

Treatment groups

270 Participants
are divided into 3 treatment groups

Sponsors and collaborators