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RECRUITINGPHASE2

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

NCT07271186•Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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

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

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

Key Dates

Start Date

January 9, 2026

Primary Completion Date

September 24, 2027

Completion Date

April 7, 2028

Last Updated

March 17, 2026

Enrollment

270

ESTIMATED participants

Conditions

Diabetic Kidney Disease (DKD)

Interventions

ALN-ANG3

DRUG

Evinacumab

DRUG

ALN-ANG3 placebo

DRUG

Evinacumab placebo

DRUG

Contacts

Clinical Trials Administrator

CONTACT

844-734-6643 clinicaltrials@regeneron.com

YiqiJiangzhuoHuoxueTongluo Method to Delay the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study1

NCT07032116

Diabetic Kidney Disease (DKD)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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