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

NCT07271186 · Regeneron Pharmaceuticals
In plain English

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Official title
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
About this study
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 criteria
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 target: 270 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-01-09
Estimated completion: 2028-04-07
Last updated: 2026-04-16
Interventions
Drug: ALN-ANG3Drug: EvinacumabDrug: ALN-ANG3 placeboDrug: Evinacumab placebo
Primary outcomes
  • Percent change in Urine Albumin to Creatinine Ratio (UACR) (Baseline to Week 24)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (39)
Applied Research Center of ArkansasRecruiting
Little Rock, Arkansas, United States
Amicis Research CenterRecruiting
Northridge, California, United States
FOMAT - Vista del Mar Medical GroupRecruiting
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North America Research InstituteRecruiting
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Amicis Research CenterRecruiting
Santa Clarita, California, United States
Amicis Research CenterRecruiting
Valencia, California, United States
National Institute of Clinical Research, Inc.Recruiting
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D&H Doral Research CenterRecruiting
Doral, Florida, United States
AGA Clinical TrialsRecruiting
Hialeah, Florida, United States
Convenient Medical CenterRecruiting
Hialeah, Florida, United States
Elixia HollywoodRecruiting
Hollywood, Florida, United States
D&H Pompano Research CenterRecruiting
Margate, Florida, United States
LCC Medical Research InstituteRecruiting
Miami, Florida, United States
D&H National Research Centers, IncRecruiting
Miami, Florida, United States
Regenerate Primary Medical Research, LLCRecruiting
Miami, Florida, United States
Ocean Blue Medical Research Center - Internal MedicineRecruiting
Miami Springs, Florida, United States
Innovia Research CenterRecruiting
Miramar, Florida, United States
Bolanos Clinical ResearchRecruiting
Pembroke Pines, Florida, United States
CDC Research InstituteRecruiting
Port Saint Lucie, Florida, United States
D&H Tamarac Research CenterRecruiting
Tamarac, Florida, United States
Metabolic Research InstituteRecruiting
West Palm Beach, Florida, United States
Privia Medical Group of Georgia, LLCRecruiting
Savannah, Georgia, United States
Research by Design, LLC - Internal MedicineRecruiting
Chicago, Illinois, United States
Elixia Michigan Kidney ConsultantsRecruiting
Pontiac, Michigan, United States
Elixia MNARecruiting
City of Saint Peters, Missouri, United States
Clinical Research Consultants, LLCRecruiting
Kansas City, Missouri, United States
Velocity Clinical ResearchRecruiting
Binghamton, New York, United States
CHEAR Center LLCRecruiting
The Bronx, New York, United States
Brookview Hills Research Associates, LLCRecruiting
Winston-Salem, North Carolina, United States
Northeast Clinical Research CenterRecruiting
Bethlehem, Pennsylvania, United States
Suburban Research AssociatesRecruiting
West Chester, Pennsylvania, United States
Southeast Renal Research InstituteRecruiting
Chattanooga, Tennessee, United States
Arlington Nephrology, PLLC.Recruiting
Arlington, Texas, United States
M3 Wake Research Dallas - Internal MedicineRecruiting
Dallas, Texas, United States
Clinical Trial Network, LLCRecruiting
Houston, Texas, United States
R & H Clinical Research, Inc.Recruiting
Katy, Texas, United States
Sunbeam Clinical ResearchRecruiting
McKinney, Texas, United States
Clinical Advancement CenterRecruiting
San Antonio, Texas, United States