RecruitingPhase 2NCT07271186

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

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


Sponsor

Regeneron Pharmaceuticals

Enrollment

270 participants

Start Date

Jan 9, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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

Exclusion Criteria4

  • 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

Interventions

DRUGEvinacumab placebo

Administered per the protocol

DRUGALN-ANG3

Administered per the protocol

DRUGEvinacumab

Administered per the protocol

DRUGALN-ANG3 placebo

Administered per the protocol


Locations(29)

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

Amicis Research Center

Northridge, California, United States

Central Coast Nephrology

Salinas, California, United States

North America Research Institute

San Dimas, California, United States

Amicis Research Center

Santa Clarita, California, United States

Amicis Research Center

Valencia, California, United States

D&H Doral Research Center

Doral, Florida, United States

AGA Clinical Trials

Hialeah, Florida, United States

Convenient Medical Center

Hialeah, Florida, United States

Elixia Hollywood

Hollywood, Florida, United States

D&H Pompano Research Center

Margate, Florida, United States

LCC Medical Research Institute

Miami, Florida, United States

D&H National Research Centers, Inc

Miami, Florida, United States

Regenerate Primary Medical Research, LLC

Miami, Florida, United States

Ocean Blue Medical Research Center - Internal Medicine

Miami Springs, Florida, United States

Innovia Research Center

Miramar, Florida, United States

Bolanos Clinical Research

Pembroke Pines, Florida, United States

D&H Tamarac Research Center

Tamarac, Florida, United States

Metabolic Research Institute

West Palm Beach, Florida, United States

Research by Design, LLC - Internal Medicine

Chicago, Illinois, United States

Elixia Michigan Kidney Consultants

Pontiac, Michigan, United States

Elixia MNA

City of Saint Peters, Missouri, United States

Clinical Research Consultants, LLC

Kansas City, Missouri, United States

Brookview Hills Research Associates, LLC

Winston-Salem, North Carolina, United States

Northeast Clinical Research Center

Bethlehem, Pennsylvania, United States

Suburban Research Associates

West Chester, Pennsylvania, United States

Southeast Renal Research Institute

Chattanooga, Tennessee, United States

Arlington Nephrology, PLLC.

Arlington, Texas, United States

Clinical Trial Network, LLC

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07271186