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

NCT07271186 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ALN-ANG3-CKD-2502
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 39

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)

Keywords

Chronic Kidney Disease (CKD); Type 2 Diabetes; Lipid Management

Outcome Measures

Primary Outcomes (1)

• Percent change in Urine Albumin to Creatinine Ratio (UACR)

  Baseline to Week 24

Secondary Outcomes (15)

• Change in Estimated Glomerular Filtration Rate (eGFR)

  Baseline to Week 24

• Change in total cholesterol

  Baseline to Week 24

• Change in Low-Density Lipoprotein-Cholesterol (LDL-C)

  Baseline to Week 24

• Change in High-Density Lipoprotein-Cholesterol (HDL-C)

  Baseline to Week 24

• Change in non-High-Density Lipoprotein-Cholesterol (non-HDL-C)

  Baseline to Week 24

Study Arms (3)

ALN-ANG3 + evinacumab placebo

EXPERIMENTAL

Drug: ALN-ANG3; Drug: Evinacumab placebo

ALN-ANG3 + evinacumab

EXPERIMENTAL

Drug: ALN-ANG3; Drug: Evinacumab

ALN-ANG3 placebo + evinacumab placebo

PLACEBO COMPARATOR

Drug: ALN-ANG3 placebo; Drug: Evinacumab placebo

Interventions

Evinacumab DRUG

Administered per the protocol

Also known as: Evkeeza®, R1500

ALN-ANG3 + evinacumab

ALN-ANG3 placebo DRUG

Administered per the protocol

ALN-ANG3 placebo + evinacumab placebo

Evinacumab placebo DRUG

Administered per the protocol

ALN-ANG3 + evinacumab placebo; ALN-ANG3 placebo + evinacumab placebo

ALN-ANG3 DRUG

Administered per the protocol

ALN-ANG3 + evinacumab; ALN-ANG3 + evinacumab placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (39)

Applied Research Center of Arkansas

Little Rock, Arkansas, 72205, United States

RECRUITING

Amicis Research Center

Northridge, California, 91325, United States

RECRUITING

FOMAT - Vista del Mar Medical Group

Oxnard, California, 93036, United States

RECRUITING

Central Coast Nephrology

Salinas, California, 93901, United States

RECRUITING

North America Research Institute

San Dimas, California, 91773, United States

RECRUITING

Amicis Research Center

Santa Clarita, California, 91355, United States

RECRUITING

Amicis Research Center

Valencia, California, 91355, United States

RECRUITING

National Institute of Clinical Research, Inc.

Victorville, California, 92392, United States

RECRUITING

D&H Doral Research Center

Doral, Florida, 33122, United States

RECRUITING

AGA Clinical Trials

Hialeah, Florida, 33012, United States

RECRUITING

Convenient Medical Center

Hialeah, Florida, 33013, United States

RECRUITING

Elixia Hollywood

Hollywood, Florida, 33024, United States

RECRUITING

D&H Pompano Research Center

Margate, Florida, 33063, United States

RECRUITING

LCC Medical Research Institute

Miami, Florida, 33126, United States

RECRUITING

D&H National Research Centers, Inc

Miami, Florida, 33155, United States

RECRUITING

Regenerate Primary Medical Research, LLC

Miami, Florida, 33155, United States

RECRUITING

Ocean Blue Medical Research Center - Internal Medicine

Miami Springs, Florida, 33166, United States

RECRUITING

Innovia Research Center

Miramar, Florida, 33027, United States

RECRUITING

Bolanos Clinical Research

Pembroke Pines, Florida, 33026, United States

RECRUITING

CDC Research Institute

Port Saint Lucie, Florida, 34952, United States

RECRUITING

D&H Tamarac Research Center

Tamarac, Florida, 33321, United States

RECRUITING

Metabolic Research Institute

West Palm Beach, Florida, 33401, United States

RECRUITING

Privia Medical Group of Georgia, LLC

Savannah, Georgia, 31406, United States

RECRUITING

Research by Design, LLC - Internal Medicine

Chicago, Illinois, 60643, United States

RECRUITING

Elixia Michigan Kidney Consultants

Pontiac, Michigan, 48341, United States

RECRUITING

Elixia MNA

City of Saint Peters, Missouri, 63376, United States

RECRUITING

Clinical Research Consultants, LLC

Kansas City, Missouri, 64111, United States

RECRUITING

Velocity Clinical Research

Binghamton, New York, 13905, United States

RECRUITING

CHEAR Center LLC

The Bronx, New York, 10455, United States

RECRUITING

Brookview Hills Research Associates, LLC

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Northeast Clinical Research Center

Bethlehem, Pennsylvania, 18017, United States

RECRUITING

Suburban Research Associates

West Chester, Pennsylvania, 19380, United States

RECRUITING

Southeast Renal Research Institute

Chattanooga, Tennessee, 37404, United States

RECRUITING

Arlington Nephrology, PLLC.

Arlington, Texas, 76015, United States

RECRUITING

M3 Wake Research Dallas - Internal Medicine

Dallas, Texas, 75224, United States

RECRUITING

Clinical Trial Network, LLC

Houston, Texas, 77074, United States

RECRUITING

R & H Clinical Research, Inc.

Katy, Texas, 77450, United States

RECRUITING

Sunbeam Clinical Research

McKinney, Texas, 75069, United States

RECRUITING

Clinical Advancement Center

San Antonio, Texas, 78212, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Interventions

evinacumab

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 9, 2025
• Study Start: January 9, 2026
• Primary Completion (Estimated): September 24, 2027
• Study Completion (Estimated): April 7, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (39)