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
Status: Recruiting
Location: See all (51) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Apogee Clinical Research, LLC
RECRUITING
Huntsville
Arkansas
Applied Research Center of Arkansas
RECRUITING
Little Rock
California
AME Clinical Research
RECRUITING
Huntington Beach
Amicis Research Center
RECRUITING
Northridge
FOMAT - Vista del Mar Medical Group
RECRUITING
Oxnard
Central Coast Nephrology
RECRUITING
Salinas
North America Research Institute
RECRUITING
San Dimas
Amicis Research Center
RECRUITING
Santa Clarita
Valiance Clinical Research
RECRUITING
Tarzana
Amicis Research Center
RECRUITING
Valencia
National Institute of Clinical Research, Inc.
RECRUITING
Victorville
Florida
D&H Doral Research Center
RECRUITING
Doral
AGA Clinical Trials
RECRUITING
Hialeah
Convenient Medical Center
RECRUITING
Hialeah
Elixia Hollywood
RECRUITING
Hollywood
D&H Pompano Research Center
RECRUITING
Margate
D&H National Research Centers, Inc
RECRUITING
Miami
LCC Medical Research Institute
RECRUITING
Miami
Regenerate Primary Medical Research, LLC
RECRUITING
Miami
Ocean Blue Medical Research Center - Internal Medicine
RECRUITING
Miami Springs
Innovia Research Center
RECRUITING
Miramar
Central Florida Kidney Specialists Oakwater
RECRUITING
Orlando
Bolanos Clinical Research
RECRUITING
Pembroke Pines
Progressive Medical Research
RECRUITING
Port Orange
CDC Research Institute
RECRUITING
Port Saint Lucie
D&H Tamarac Research Center
RECRUITING
Tamarac
Metabolic Research Institute
RECRUITING
West Palm Beach
Georgia
Privia Medical Group of Georgia, LLC
RECRUITING
Savannah
Illinois
Research by Design, LLC - Internal Medicine
RECRUITING
Chicago
Louisiana
IMA Clinical Research
RECRUITING
Monroe
Michigan
Elixia Michigan Kidney Consultants
RECRUITING
Pontiac
Missouri
Elixia MNA
RECRUITING
City Of Saint Peters
Clinical Research Consultants, LLC
RECRUITING
Kansas City
North Carolina
Eastern Nephrology Associates - Greenville West
RECRUITING
Greenville
Brookview Hills Research Associates, LLC
RECRUITING
Winston-salem
Nevada
DaVita Clinical Research
RECRUITING
Las Vegas
New York
Velocity Clinical Research
RECRUITING
Binghamton
CHEAR Center LLC
RECRUITING
The Bronx
Pennsylvania
Northeast Clinical Research Center
RECRUITING
Bethlehem
Suburban Research Associates
RECRUITING
West Chester
Tennessee
Southeast Renal Research Institute
RECRUITING
Chattanooga
Texas
Arlington Nephrology, PLLC.
RECRUITING
Arlington
M3 Wake Research Dallas - Internal Medicine
RECRUITING
Dallas
Revival Research Institute, LLC
RECRUITING
Dallas
El Paso Kidney Specialists-Davita Clinical Research
RECRUITING
El Paso
Clinical Trial Network, LLC
RECRUITING
Houston
Juno Research, LLC
RECRUITING
Houston
Gulf Coast Clinical Research
RECRUITING
Katy
R & H Clinical Research, Inc.
RECRUITING
Katy
Sunbeam Clinical Research
RECRUITING
Mckinney
Clinical Advancement Center
RECRUITING
San Antonio
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2026-01-09
Estimated Completion Date: 2028-04-07
Participants
Target number of participants: 270
Treatments
Experimental: ALN-ANG3 + evinacumab placebo
Experimental: ALN-ANG3 + evinacumab
Placebo_comparator: ALN-ANG3 placebo + evinacumab placebo
Related Therapeutic Areas
Sponsors
Leads: Regeneron Pharmaceuticals