RightFit
RecruitingPhase 2

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

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of ALN-ANG3 in Participants With Diabetic Kidney Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ALN-ANG3, an experimental drug, in adults with kidney disease caused by diabetes. It looks at how safe the drug is and how well it works. It also checks side effects and drug levels in the blood over time.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have type 2 diabetes and use medicine or lifestyle changes to manage blood sugar.
  • Have an HbA1c result of 6.5% to 10% at screening. This test measures average blood sugar.
  • Have an eGFR result of 30 to 90 mL/min/1.73 m² at screening. This test estimates how well your kidneys filter blood.
  • Have a urine albumin-to-creatinine ratio (UACR) of 500 to 5000 mg/g at screening. This test measures protein in your urine.

Who can't join

  • Have a history or signs of kidney disease not caused by diabetes.
  • Have kidney disease that needs or has needed drugs that lower immune system activity throughout the body.
  • Have a history of kidney failure that required long-term dialysis (treatment to filter blood) or a kidney transplant.
  • Have health that the study doctor judges to be unstable, or had a hospital stay longer than 24 hours within 30 days before screening.
  • Other study rules also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (58)

AL

AR

CA

CT

FL

GA

IL

LA

MI

MO

NC

NE

NV

NY

PA

TN

TX