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

NCT ID: NCT07271186

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-09

Study Completion Date

2027-12-08

Brief Summary

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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

Detailed Description

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Conditions

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Diabetic Kidney Disease (DKD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ALN-ANG3 + evinacumab placebo

Group Type EXPERIMENTAL

ALN-ANG3

Intervention Type DRUG

Administered per the protocol

Evinacumab placebo

Intervention Type DRUG

Administered per the protocol

ALN-ANG3 + evinacumab

Group Type EXPERIMENTAL

ALN-ANG3

Intervention Type DRUG

Administered per the protocol

Evinacumab

Intervention Type DRUG

Administered per the protocol

ALN-ANG3 placebo + evinacumab placebo

Group Type PLACEBO_COMPARATOR

ALN-ANG3 placebo

Intervention Type DRUG

Administered per the protocol

Evinacumab placebo

Intervention Type DRUG

Administered per the protocol

Interventions

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ALN-ANG3

Administered per the protocol

Intervention Type DRUG

Evinacumab

Administered per the protocol

Intervention Type DRUG

ALN-ANG3 placebo

Administered per the protocol

Intervention Type DRUG

Evinacumab placebo

Administered per the protocol

Intervention Type DRUG

Other Intervention Names

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Evkeeza® R1500

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Central Contacts

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Clinical Trials Administrator

Role: CONTACT

844-734-6643

Other Identifiers

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ALN-ANG3-CKD-2502

Identifier Type: -

Identifier Source: org_study_id

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