Study to Assess the Effects of ALN-ANG3 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; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07271186

2026-527519-41-00 (EU Trial (CTIS) Number)

ALN-ANG3-CKD-2502

Details and patient eligibility

About

This study is researching an experimental drug called ALN-ANG3 (called "study drug"). 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: 195 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 (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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195 participants in 3 patient groups, including a placebo group

ALN-ANG3 + evinacumab

Experimental group

Description:

This arm has been closed

Treatment:

Drug: ALN-ANG3

Drug: Evinacumab

ALN-ANG3

Experimental group

Treatment:

Drug: ALN-ANG3

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo