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

Regeneron Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Diabetic Kidney Disease (DKD)

Treatments: Drug: Evinacumab; Drug: ALN-ANG3 placebo; Drug: ALN-ANG3; Drug: Evinacumab placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07271186

ALN-ANG3-CKD-2502

Details and patient eligibility

About

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

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 3 patient groups, including a placebo group

ALN-ANG3 + evinacumab placebo

Experimental group

Treatment:

Drug: Evinacumab placebo

Drug: ALN-ANG3

ALN-ANG3 + evinacumab

Experimental group

Treatment:

Drug: ALN-ANG3

Drug: Evinacumab

ALN-ANG3 placebo + evinacumab placebo

Placebo Comparator group

Treatment:

Drug: Evinacumab placebo

Drug: ALN-ANG3 placebo