Study to Assess the Effects of ALN-ANG3 in Adult Participants With Diabetic Kidney Disease

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRegeneron Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 m² 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

Disqualifiers

Known medical history or clinical evidence indicative of non-diabetic renal disease

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

Medically unstable as assessed by the investigator or hospitalization (ie, >24 hours) within 30 days of the screening visit

Trial design

Design model

Parallel

Treatments tested in this trial

  • ALN-ANG3

    Drug

    Administered per the protocol

  • Evinacumab

    Drug

    No longer being administered

  • Placebo

    Drug

    Administered per the protocol

Treatment groups

195 Participants
are divided into 3 treatment groups
Group A: ALN-ANG3 + evinacumabExperimental treatment 2 interventions
Group B: ALN-ANG3Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change in Urine Albumin to Creatinine Ratio (UACR)

Time frame
Baseline to Week 24

Secondary outcomes

1

Change in Estimated Glomerular Filtration Rate (eGFR)

Time frame
Baseline to Week 24
2

Change in Total Cholesterol

Time frame
Baseline to Week 24
3

Change in Low-Density Lipoprotein-Cholesterol (LDL-C)

Time frame
Baseline to Week 24
4

Change in High-Density Lipoprotein-Cholesterol (HDL-C)

Time frame
Baseline to Week 24

Other outcomes

Sponsors and contacts

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