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

NCT07271186
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Recruiting
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Participants
270
clinicaltrials.gov
Lead sponsor
Regeneron Pharmaceuticals
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Start date
2026-01-09
clinicaltrials.gov
Number of sites
58
clinicaltrials.gov

Summary
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
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Acronym
ANCHOR-POC
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Short title
Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease
clinicaltrials.gov
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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-04-07
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First posted
2025-12-09
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Registry last updated
2026-08-10
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Primary completion date
2027-09-24
clinicaltrials.gov
Start date
2026-01-09
clinicaltrials.gov

Participants
270
clinicaltrials.gov
Participant count basis
Estimated
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Planned participants
270
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Protocol amendments
0
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Number of sites
58
clinicaltrials.gov

Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Regeneron Pharmaceuticals
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07271186
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07271186
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percent change in Urine Albumin to Creatinine Ratio (UACR)

    Timeframe: Baseline to Week 24

  1. Change in Estimated Glomerular Filtration Rate (eGFR)

    Timeframe: Baseline to Week 24

  2. Change in total cholesterol

    Timeframe: Baseline to Week 24

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

    Timeframe: Baseline to Week 24

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

    Timeframe: Baseline to Week 24

  5. Change in non-High-Density Lipoprotein-Cholesterol (non-HDL-C)

    Timeframe: Baseline to Week 24

  6. Change in triglycerides

    Timeframe: Baseline to Week 24

  7. Change in Apolipoprotein B (ApoB)

    Timeframe: Baseline to Week 24

  8. Concentration of combined ALN-ANG3 and metabolite(s) and evinacumab

    Timeframe: Up to Week 24

  9. Change in concentration of Angiopoietin-Like Protein-3 (ANGPTL-3)

    Timeframe: Baseline to Week 24

  10. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Timeframe: Up to Week 48

  11. Severity of TEAEs

    Timeframe: Up to Week 48

  12. Incidence of ADAs to ALN-ANG3

    Timeframe: Through Week 24

  13. Magnitude of ADAs to ALN-ANG3

    Timeframe: Through Week 24

  14. Incidence of ADAs to evinacumab

    Timeframe: Through Week 24

  15. Magnitude of ADAs to evinacumab

    Timeframe: Through Week 24

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

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, 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

NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply

Sources for eligibility
clinicaltrials.gov

  • Apogee Clinical Research, LLCHuntsville, United StatesRecruiting
  • Applied Research Center of ArkansasLittle Rock, United StatesRecruiting
  • AME Clinical ResearchHuntington Beach, United StatesRecruiting
  • Amicis Research CenterNorthridge, United StatesRecruiting
  • FOMAT - Vista del Mar Medical GroupOxnard, United StatesRecruiting
  • Central Coast NephrologySalinas, United StatesRecruiting
  • North America Research InstituteSan Dimas, United StatesRecruiting
  • Amicis Research CenterSanta Clarita, United StatesRecruiting
  • Valiance Clinical ResearchTarzana, United StatesRecruiting
  • Amicis Research CenterValencia, United StatesRecruiting
  • National Institute of Clinical Research, Inc.Victorville, United StatesRecruiting
  • Yale UniversityNew Haven, United StatesRecruiting
  • D&H Doral Research CenterDoral, United StatesRecruiting
  • AGA Clinical TrialsHialeah, United StatesRecruiting
  • Convenient Medical CenterHialeah, United StatesRecruiting
  • Elixia HollywoodHollywood, United StatesRecruiting
  • D&H Pompano Research CenterMargate, United StatesRecruiting
  • LCC Medical Research InstituteMiami, United StatesRecruiting
  • D&H National Research Centers, IncMiami, United StatesRecruiting
  • Regenerate Primary Medical Research, LLCMiami, United StatesRecruiting
  • Ocean Blue Medical Research Center - Internal MedicineMiami Springs, United StatesRecruiting
  • Innovia Research CenterMiramar, United StatesRecruiting
  • Central Florida Kidney Specialists OakwaterOrlando, United StatesRecruiting
  • Bolanos Clinical ResearchPembroke Pines, United StatesRecruiting
  • Progressive Medical ResearchPort Orange, United StatesRecruiting

And 33 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)

Targets (1)