ANGPTL3 inhibition for adults with diabetic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 (prior or current), or a history of end-stage kidney disease requiring treatment with chronic dialysis or kidney transplantation
3. Medically unstable as assessed by the investigator or hospitalization (ie, \>24 hours) within 30 days of the screening visit

NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply

Where it's running

• 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
• North America Research Institute
  San Dimas, California, United States Recruiting

+9 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Amimestrocel (umbilical cord mesenchymal stromal cells) for diabetic kidney disease

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• Isuzinaxib for adults with diabetic kidney disease

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  Recruiting at 17 sites Phase 2 Aptabio Therapeutics, Inc. · Ansan-si and 19 other locations · NCT06962098

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.