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NCT07271186PHASE2Recruiting

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

Regeneron Pharmaceuticals

Start Date

1/9/2026

Completion Date

4/7/2028

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

Age Range: 18 years to 80 years

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

Interventions

DRUG

ALN-ANG3

DRUG

Evinacumab

DRUG

ALN-ANG3 placebo

DRUG

Evinacumab placebo

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Conditions

Diabetic Kidney Disease (DKD)

Locations

Apogee Clinical Research, LLC

Huntsville, Alabama 35801

United States

Applied Research Center of Arkansas

Little Rock, Arkansas 72205

United States

AME Clinical Research

Huntington Beach, California 92647

United States

Amicis Research Center

Northridge, California 91325

United States

FOMAT - Vista del Mar Medical Group

Oxnard, California 93036

United States

Central Coast Nephrology

Salinas, California 93901

United States

North America Research Institute

San Dimas, California 91773

United States

Amicis Research Center

Santa Clarita, California 91355

United States

Valiance Clinical Research

Tarzana, California 91356

United States

Amicis Research Center

Valencia, California 91355

United States

National Institute of Clinical Research, Inc.

Victorville, California 92392

United States

Yale University

New Haven, Connecticut 06510

United States

D&H Doral Research Center

Doral, Florida 33122

United States

AGA Clinical Trials

Hialeah, Florida 33012

United States

Convenient Medical Center

Hialeah, Florida 33013

United States

Elixia Hollywood

Hollywood, Florida 33024

United States

D&H Pompano Research Center

Margate, Florida 33063

United States

LCC Medical Research Institute

Miami, Florida 33126

United States

D&H National Research Centers, Inc

Miami, Florida 33155

United States

Regenerate Primary Medical Research, LLC

Miami, Florida 33155

United States

Ocean Blue Medical Research Center - Internal Medicine

Miami Springs, Florida 33166

United States

Innovia Research Center

Miramar, Florida 33027

United States

Central Florida Kidney Specialists Oakwater

Orlando, Florida 32806

United States

Bolanos Clinical Research

Pembroke Pines, Florida 33026

United States

Progressive Medical Research

Port Orange, Florida 32127

United States

CDC Research Institute

Port Saint Lucie, Florida 34952

United States

D&H Tamarac Research Center

Tamarac, Florida 33321

United States

Metabolic Research Institute

West Palm Beach, Florida 33401

United States

Privia Medical Group of Georgia, LLC

Savannah, Georgia 31406

United States

Research by Design, LLC - Internal Medicine

Chicago, Illinois 60643

United States

IMA Clinical Research

Monroe, Louisiana 71201

United States

Elixia Michigan Kidney Consultants

Pontiac, Michigan 48341

United States

Elixia MNA

City of Saint Peters, Missouri 63376

United States

Clinical Research Consultants, LLC

Kansas City, Missouri 64111

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

DaVita Clinical Research

Las Vegas, Nevada 89107

United States

Velocity Clinical Research

Binghamton, New York 13905

United States

CHEAR Center LLC

The Bronx, New York 10455

United States

Eastern Nephrology Associates - Greenville West

Greenville, North Carolina 27834

United States

Eastern Nephrology Associates - New Bern

New Bern, North Carolina 28562

United States

Brookview Hills Research Associates, LLC

Winston-Salem, North Carolina 27103

United States

Northeast Clinical Research Center

Bethlehem, Pennsylvania 18017

United States

Suburban Research Associates

West Chester, Pennsylvania 19380

United States

Southeast Renal Research Institute

Chattanooga, Tennessee 37404

United States

Arlington Nephrology, PLLC.

Arlington, Texas 76015

United States

M3 Wake Research Dallas - Internal Medicine

Dallas, Texas 75224

United States

Revival Research Institute, LLC

Dallas, Texas 75231

United States

Epic Medical Research LLC

DeSoto, Texas 75115

United States

El Paso Kidney Specialists-Davita Clinical Research

El Paso, Texas 79902

United States

Juno Research, LLC

Houston, Texas 77040

United States

Prolato Research LLC

Houston, Texas 77054

United States

Clinical Trial Network, LLC

Houston, Texas 77074

United States

Gulf Coast Clinical Research

Katy, Texas 77450

United States

R & H Clinical Research, Inc.

Katy, Texas 77450

United States

Sunbeam Clinical Research

McKinney, Texas 75069

United States

Clinical Advancement Center

San Antonio, Texas 78212

United States

University of Texas Health - San Antonio

San Antonio, Texas 78229

United States