ANGPTL3 inhibition for adults 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
This study tests whether two drugs that block ANGPTL3, ALN-ANG3 and evinacumab, are safe and help adults with type 2 diabetes who have diabetic kidney disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Drugs / interventions | evinacumab |
| Locations | 47 sites (Huntsville, Alabama and 46 other locations) |
| Trial ID | NCT07271186 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives participants ALN-ANG3, evinacumab, or matched placebo and follows them over time for safety, drug levels in the blood, and effects on kidney-related measures such as albuminuria and estimated glomerular filtration rate. Eligible adults have type 2 diabetes with moderate-to-severe albuminuria and an eGFR between 30 and 90 mL/min/1.73 m2. The study monitors side effects, pharmacokinetics, and exploratory efficacy signals to inform further development. Results will help determine whether ANGPTL3 inhibition merits larger trials in diabetic kidney disease.
Who should consider this trial
Good fit: Adults with type 2 diabetes who have diabetic kidney disease with HbA1c 6.5–10%, eGFR 30–90 mL/min/1.73 m2, and urine albumin-to-creatinine ratio of 500–5000 mg/g are the intended candidates.
Not a fit: People with non-diabetic kidney disease, those on dialysis or with a prior kidney transplant, medically unstable patients, or those recently hospitalized are unlikely to benefit or be eligible for this study.
Why it matters
Potential benefit: If successful, blocking ANGPTL3 could lower harmful lipids and slow progression of kidney damage in people with diabetic kidney disease.
How similar studies have performed: ANGPTL3 inhibition has produced strong lipid-lowering effects in prior studies and evinacumab is approved for rare lipid disorders, but its specific benefit for diabetic kidney disease remains largely unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Huntsville, Alabama and 46 other locations
- Apogee Clinical Research, LLC — Huntsville, Alabama, United States (Recruiting)
- Applied Research Center of Arkansas — Little Rock, Arkansas, United States (Recruiting)
- AME Clinical Research — Huntington Beach, California, United States (Recruiting)
- Amicis Research Center — Northridge, California, United States (Recruiting)
- FOMAT - Vista del Mar Medical Group — Oxnard, California, United States (Recruiting)
- Central Coast Nephrology — Salinas, California, United States (Recruiting)
- North America Research Institute — San Dimas, California, United States (Recruiting)
- Amicis Research Center — Santa Clarita, California, United States (Recruiting)
- Valiance Clinical Research — Tarzana, California, United States (Recruiting)
- Amicis Research Center — Valencia, California, United States (Recruiting)
- National Institute of Clinical Research, Inc. — Victorville, California, United States (Recruiting)
- D&H Doral Research Center — Doral, Florida, United States (Recruiting)
- AGA Clinical Trials — Hialeah, Florida, United States (Recruiting)
- Convenient Medical Center — Hialeah, Florida, United States (Recruiting)
- Elixia Hollywood — Hollywood, Florida, United States (Recruiting)
- D&H Pompano Research Center — Margate, Florida, United States (Recruiting)
- LCC Medical Research Institute — Miami, Florida, United States (Recruiting)
- D&H National Research Centers, Inc — Miami, Florida, United States (Recruiting)
- Regenerate Primary Medical Research, LLC — Miami, Florida, United States (Recruiting)
- Ocean Blue Medical Research Center - Internal Medicine — Miami Springs, Florida, United States (Recruiting)
- Innovia Research Center — Miramar, Florida, United States (Recruiting)
- Bolanos Clinical Research — Pembroke Pines, Florida, United States (Recruiting)
- Progressive Medical Research — Port Orange, Florida, United States (Recruiting)
- CDC Research Institute — Port Saint Lucie, Florida, United States (Recruiting)
- D&H Tamarac Research Center — Tamarac, Florida, United States (Recruiting)
- Metabolic Research Institute — West Palm Beach, Florida, United States (Recruiting)
- Privia Medical Group of Georgia, LLC — Savannah, Georgia, United States (Recruiting)
- Research by Design, LLC - Internal Medicine — Chicago, Illinois, United States (Recruiting)
- Elixia Michigan Kidney Consultants — Pontiac, Michigan, United States (Recruiting)
- Elixia MNA — City of Saint Peters, Missouri, United States (Recruiting)
- Clinical Research Consultants, LLC — Kansas City, Missouri, United States (Recruiting)
- DaVita Clinical Research — Las Vegas, Nevada, United States (Recruiting)
- Velocity Clinical Research — Binghamton, New York, United States (Recruiting)
- CHEAR Center LLC — The Bronx, New York, United States (Recruiting)
- Brookview Hills Research Associates, LLC — Winston-Salem, North Carolina, United States (Recruiting)
- Northeast Clinical Research Center — Bethlehem, Pennsylvania, United States (Recruiting)
- Suburban Research Associates — West Chester, Pennsylvania, United States (Recruiting)
- Southeast Renal Research Institute — Chattanooga, Tennessee, United States (Recruiting)
- Arlington Nephrology, PLLC. — Arlington, Texas, United States (Recruiting)
- M3 Wake Research Dallas - Internal Medicine — Dallas, Texas, United States (Recruiting)
- El Paso Kidney Specialists-Davita Clinical Research — El Paso, Texas, United States (Recruiting)
- Juno Research, LLC — Houston, Texas, United States (Recruiting)
- Clinical Trial Network, LLC — Houston, Texas, United States (Recruiting)
- Gulf Coast Clinical Research — Katy, Texas, United States (Recruiting)
- R & H Clinical Research, Inc. — Katy, Texas, United States (Recruiting)
- Sunbeam Clinical Research — McKinney, Texas, United States (Recruiting)
- Clinical Advancement Center — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.