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

May 19, 2026 updated by: Regeneron Pharmaceuticals

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Apogee Clinical Research, LLC
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Applied Research Center of Arkansas
    • California
      • Huntington Beach, California, United States, 92647
        • Recruiting
        • AME Clinical Research
      • Northridge, California, United States, 91325
        • Recruiting
        • Amicis Research Center
      • Oxnard, California, United States, 93036
        • Recruiting
        • FOMAT - Vista del Mar Medical Group
      • Salinas, California, United States, 93901
        • Recruiting
        • Central Coast Nephrology
      • San Dimas, California, United States, 91773
        • Recruiting
        • North America Research Institute
      • Santa Clarita, California, United States, 91355
        • Recruiting
        • Amicis Research Center
      • Tarzana, California, United States, 91356
        • Recruiting
        • Valiance Clinical Research
      • Valencia, California, United States, 91355
        • Recruiting
        • Amicis Research Center
      • Victorville, California, United States, 92392
        • Recruiting
        • National Institute of Clinical Research, Inc.
    • Florida
      • Doral, Florida, United States, 33122
        • Recruiting
        • D&H Doral Research Center
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • AGA Clinical Trials
      • Hialeah, Florida, United States, 33013
        • Recruiting
        • Convenient Medical Center
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Elixia Hollywood
      • Margate, Florida, United States, 33063
        • Recruiting
        • D&H Pompano Research Center
      • Miami, Florida, United States, 33155
        • Recruiting
        • D&H National Research Centers, Inc
      • Miami, Florida, United States, 33126
        • Recruiting
        • LCC Medical Research Institute
      • Miami, Florida, United States, 33155
        • Recruiting
        • Regenerate Primary Medical Research, LLC
      • Miami Springs, Florida, United States, 33166
        • Recruiting
        • Ocean Blue Medical Research Center - Internal Medicine
      • Miramar, Florida, United States, 33027
        • Recruiting
        • Innovia Research Center
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Central Florida Kidney Specialists Oakwater
      • Pembroke Pines, Florida, United States, 33026
        • Recruiting
        • Bolanos Clinical Research
      • Port Orange, Florida, United States, 32127
        • Recruiting
        • Progressive Medical Research
      • Port Saint Lucie, Florida, United States, 34952
        • Recruiting
        • CDC Research Institute
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • D&H Tamarac Research Center
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Metabolic Research Institute
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Privia Medical Group of Georgia, LLC
    • Illinois
      • Chicago, Illinois, United States, 60643
        • Recruiting
        • Research by Design, LLC - Internal Medicine
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Recruiting
        • Ima Clinical Research
    • Michigan
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Elixia Michigan Kidney Consultants
    • Missouri
      • City of Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Elixia MNA
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Clinical Research Consultants, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89107
        • Recruiting
        • Davita Clinical Research
    • New York
      • Binghamton, New York, United States, 13905
        • Recruiting
        • Velocity Clinical Research
      • The Bronx, New York, United States, 10455
        • Recruiting
        • CHEAR Center LLC
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Eastern Nephrology Associates - Greenville West
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Brookview Hills Research Associates, LLC
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Recruiting
        • Northeast Clinical Research Center
      • West Chester, Pennsylvania, United States, 19380
        • Recruiting
        • Suburban Research Associates
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Recruiting
        • Southeast Renal Research Institute
    • Texas
      • Arlington, Texas, United States, 76015
        • Recruiting
        • Arlington Nephrology, PLLC.
      • Dallas, Texas, United States, 75224
        • Recruiting
        • M3 Wake Research Dallas - Internal Medicine
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Revival Research Institute, LLC
      • El Paso, Texas, United States, 79902
        • Recruiting
        • El Paso Kidney Specialists-Davita Clinical Research
      • Houston, Texas, United States, 77040
        • Recruiting
        • Juno Research, LLC
      • Houston, Texas, United States, 77074
        • Recruiting
        • Clinical Trial Network, LLC
      • Katy, Texas, United States, 77450
        • Recruiting
        • R & H Clinical Research, Inc.
      • Katy, Texas, United States, 77450
        • Recruiting
        • Gulf Coast Clinical Research
      • McKinney, Texas, United States, 75069
        • Recruiting
        • Sunbeam Clinical Research
      • San Antonio, Texas, United States, 78212
        • Recruiting
        • Clinical Advancement Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALN-ANG3 + evinacumab placebo
Drug: ALN-ANG3
Administered per the protocol
Drug: Evinacumab placebo
Administered per the protocol
Experimental: ALN-ANG3 + evinacumab
Drug: ALN-ANG3
Administered per the protocol
Drug: Evinacumab
Administered per the protocol
Other Names:
  • Evkeeza®
  • R1500
Placebo Comparator: ALN-ANG3 placebo + evinacumab placebo
Drug: Evinacumab placebo
Administered per the protocol
Drug: ALN-ANG3 placebo
Administered per the protocol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline to Week 24
Baseline to Week 24
Change in total cholesterol
Time Frame: Baseline to Week 24
Baseline to Week 24
Change in Low-Density Lipoprotein-Cholesterol (LDL-C)
Time Frame: Baseline to Week 24
Baseline to Week 24
Change in High-Density Lipoprotein-Cholesterol (HDL-C)
Time Frame: Baseline to Week 24
Baseline to Week 24
Change in non-High-Density Lipoprotein-Cholesterol (non-HDL-C)
Time Frame: Baseline to Week 24
Baseline to Week 24
Change in triglycerides
Time Frame: Baseline to Week 24
Baseline to Week 24
Change in Apolipoprotein B (ApoB)
Time Frame: Baseline to Week 24
Baseline to Week 24
Concentration of combined ALN-ANG3 and metabolite(s) and evinacumab
Time Frame: Up to Week 24
Up to Week 24
Change in concentration of Angiopoietin-Like Protein-3 (ANGPTL-3)
Time Frame: Baseline to Week 24
Baseline to Week 24
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to Week 48
Up to Week 48
Severity of TEAEs
Time Frame: Up to Week 48
Up to Week 48
Incidence of ADAs to ALN-ANG3
Time Frame: Through Week 24
Through Week 24
Magnitude of ADAs to ALN-ANG3
Time Frame: Through Week 24
Through Week 24
Incidence of ADAs to evinacumab
Time Frame: Through Week 24
Through Week 24
Magnitude of ADAs to evinacumab
Time Frame: Through Week 24
Through Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2026

Primary Completion (Estimated)

September 24, 2027

Study Completion (Estimated)

April 7, 2028

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 7, 2025

First Posted (Actual)

December 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALN-ANG3-CKD-2502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing 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

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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