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Recruiting NCT07271186

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

Phase II Interventional Diabetic Kidney Disease (DKD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ALN-ANG3, Evinacumab, ALN-ANG3 placebo, Evinacumab placebo.
Who it may be relevant to
Registry conditions: Diabetic Kidney Disease (DKD). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Drug ALN-ANG3
    Administered per the protocol
  • Drug Evinacumab
    Administered per the protocol
  • Drug ALN-ANG3 placebo
    Administered per the protocol
  • Drug Evinacumab placebo
    Administered per the protocol

Primary outcome measures

  • Percent change in Urine Albumin to Creatinine Ratio (UACR) [Time frame: Baseline to Week 24]
Secondary outcome measures (12)
  • Change in Estimated Glomerular Filtration Rate (eGFR) [Time frame: Baseline to Week 24]
  • Change in total cholesterol [Time frame: Baseline to Week 24]
  • Change in Low-Density Lipoprotein-Cholesterol (LDL-C) [Time frame: Baseline to Week 24]
  • Change in High-Density Lipoprotein-Cholesterol (HDL-C) [Time frame: Baseline to Week 24]
  • Change in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) [Time frame: Baseline to Week 24]
  • Change in triglycerides [Time frame: Baseline to Week 24]
  • Change in Apolipoprotein B (ApoB) [Time frame: Baseline to Week 24]
  • Concentration of combined ALN-ANG3 and metabolite(s) and evinacumab [Time frame: Up to Week 24]
  • Change in concentration of Angiopoietin-Like Protein-3 (ANGPTL-3) [Time frame: Baseline to Week 24]
  • Occurrence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to Week 48]
  • Severity of TEAEs [Time frame: Up to Week 48]
  • Incidence of ADAs to ALN-ANG3 [Time frame: Through Week 24]

Eligibility criteria

Inclusion criteria

  • Medical history of type 2 diabetes and receiving medical therapy or lifestyle interventions for glucose management
  • Hemoglobin A1C (HbA1c) of 6.5 to 10% at screening
  • 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
  • Albuminuria: Urine Albumin to Creatinine Ratio (UACR) of 500 to 5000 mg/g at screening

Exclusion criteria

  • Known medical history or clinical evidence indicative of non-diabetic renal disease
  • Renal disease that required treatment with systemic immunosuppressive therapy, or a history of dialysis or renal transplant
  • Medically unstable as assessed by the investigator
  • Hospitalization (ie, >24 hours) within 30 days of the screening visit

NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 57 centers
  • Apogee Clinical Research, LLC — Huntsville
  • Applied Research Center of Arkansas — Little Rock
  • AME Clinical Research — Huntington Beach
  • Amicis Research Center — Northridge
  • FOMAT - Vista del Mar Medical Group — Oxnard
  • Central Coast Nephrology — Salinas
  • North America Research Institute — San Dimas
  • Amicis Research Center — Santa Clarita
  • … and 49 more centers

Identifiers

NCT: NCT07271186 · ALN-ANG3-CKD-2502

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗