Recruiting

Phase 2

ALN-ANG3 & EvinacumabStudy to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07271186

Conditions

Diabetic Kidney Disease (DKD)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ALN-ANG3

Evinacumab

ALN-ANG3 placebo

Evinacumab placebo

Study Details

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

Conditions

Diabetic Kidney Disease (DKD)

Study ID

NCT07271186

Start date

Jan 9, 2026

Status verified date

Aug, 2026

Completion date

Apr 7, 2028

Anticipated

Primary completion date

Sep 24, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALN-ANG3 + evinacumab placebo

experimental: ALN-ANG3 + evinacumab

placebo comparator: ALN-ANG3 placebo + evinacumab placebo

Interventions

ALN-ANG3

Administered per the protocol

Evinacumab

Administered per the protocol

ALN-ANG3 placebo

Administered per the protocol

Evinacumab placebo

Administered per the protocol

Primary outcome measure

Percent change in Urine Albumin to Creatinine Ratio (UACR) [ Time Frame: Baseline to Week 24 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643 clinicaltrials@regeneron.com

Locations

Apogee Clinical Research, LLC

Recruiting

Huntsville, Alabama, United States, 35801

Applied Research Center of Arkansas

Recruiting

Little Rock, Arkansas, United States, 72205

AME Clinical Research

Recruiting

Huntington Beach, California, United States, 92647

Amicis Research Center

Recruiting

Northridge, California, United States, 91325

FOMAT - Vista del Mar Medical Group

Recruiting

Oxnard, California, United States, 93036

Central Coast Nephrology

Recruiting

Salinas, California, United States, 93901

North America Research Institute

Recruiting

San Dimas, California, United States, 91773

Amicis Research Center

Recruiting

Santa Clarita, California, United States, 91355

Valiance Clinical Research

Recruiting

Tarzana, California, United States, 91356

Amicis Research Center

Recruiting

Valencia, California, United States, 91355

National Institute of Clinical Research, Inc.

Recruiting

Victorville, California, United States, 92392

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

D&H Doral Research Center

Recruiting

Doral, Florida, United States, 33122

AGA Clinical Trials

Recruiting

Hialeah, Florida, United States, 33012

Convenient Medical Center

Recruiting

Hialeah, Florida, United States, 33013

Elixia Hollywood

Recruiting

Hollywood, Florida, United States, 33024

D&H Pompano Research Center

Recruiting

Margate, Florida, United States, 33063

LCC Medical Research Institute

Recruiting

Miami, Florida, United States, 33126

D&H National Research Centers, Inc

Recruiting

Miami, Florida, United States, 33155

Regenerate Primary Medical Research, LLC

Recruiting

Miami, Florida, United States, 33155

Ocean Blue Medical Research Center - Internal Medicine

Recruiting

Miami Springs, Florida, United States, 33166

Innovia Research Center

Recruiting

Miramar, Florida, United States, 33027

Central Florida Kidney Specialists Oakwater

Recruiting

Orlando, Florida, United States, 32806

Bolanos Clinical Research

Recruiting

Pembroke Pines, Florida, United States, 33026

Progressive Medical Research

Recruiting

Port Orange, Florida, United States, 32127

CDC Research Institute

Recruiting

Port Saint Lucie, Florida, United States, 34952

D&H Tamarac Research Center

Recruiting

Tamarac, Florida, United States, 33321

Metabolic Research Institute

Recruiting

West Palm Beach, Florida, United States, 33401

Privia Medical Group of Georgia, LLC

Recruiting

Savannah, Georgia, United States, 31406

Research by Design, LLC - Internal Medicine

Recruiting

Chicago, Illinois, United States, 60643

IMA Clinical Research

Recruiting

Monroe, Louisiana, United States, 71201

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Elixia Michigan Kidney Consultants

Recruiting

Pontiac, Michigan, United States, 48341

Elixia MNA

Recruiting

City of Saint Peters, Missouri, United States, 63376

Clinical Research Consultants, LLC

Recruiting

Kansas City, Missouri, United States, 64111

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

DaVita Clinical Research

Recruiting

Las Vegas, Nevada, United States, 89107

Velocity Clinical Research

Recruiting

Binghamton, New York, United States, 13905

CHEAR Center LLC

Recruiting

The Bronx, New York, United States, 10455

Eastern Nephrology Associates - Greenville West

Recruiting

Greenville, North Carolina, United States, 27834

Eastern Nephrology Associates - New Bern

Recruiting

New Bern, North Carolina, United States, 28562

Brookview Hills Research Associates, LLC

Recruiting

Winston-Salem, North Carolina, United States, 27103

Northeast Clinical Research Center

Recruiting

Bethlehem, Pennsylvania, United States, 18017

Suburban Research Associates

Recruiting

West Chester, Pennsylvania, United States, 19380

Southeast Renal Research Institute

Recruiting

Chattanooga, Tennessee, United States, 37404

Arlington Nephrology, PLLC.

Recruiting

Arlington, Texas, United States, 76015

M3 Wake Research Dallas - Internal Medicine

Recruiting

Dallas, Texas, United States, 75224

Revival Research Institute, LLC

Recruiting

Dallas, Texas, United States, 75231

Epic Medical Research LLC

Recruiting

DeSoto, Texas, United States, 75115

El Paso Kidney Specialists-Davita Clinical Research

Recruiting

El Paso, Texas, United States, 79902

Juno Research, LLC

Recruiting

Houston, Texas, United States, 77040

Prolato Research LLC

Recruiting

Houston, Texas, United States, 77054

Clinical Trial Network, LLC

Recruiting

Houston, Texas, United States, 77074

Gulf Coast Clinical Research

Recruiting

Katy, Texas, United States, 77450

R & H Clinical Research, Inc.

Recruiting

Katy, Texas, United States, 77450

Sunbeam Clinical Research

Recruiting

McKinney, Texas, United States, 75069

Clinical Advancement Center

Recruiting

San Antonio, Texas, United States, 78212

University of Texas Health - San Antonio

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

Chronic Kidney Disease (CKD)
Type 2 Diabetes
Lipid Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-10.