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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALN-ANG3 + evinacumab placebo | Experimental |
| |
| ALN-ANG3 + evinacumab | Experimental |
| |
| ALN-ANG3 placebo + evinacumab placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-ANG3 | Drug | Administered per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in Urine Albumin to Creatinine Ratio (UACR) | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Estimated Glomerular Filtration Rate (eGFR) | Baseline to Week 24 | |
| Change in total cholesterol | Baseline to Week 24 | |
| Change in Low-Density Lipoprotein-Cholesterol (LDL-C) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apogee Clinical Research, LLC | Recruiting | Huntsville | Alabama | 35801 | United States | |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| Evinacumab | Drug | Administered per the protocol |
|
|
| ALN-ANG3 placebo | Drug | Administered per the protocol |
|
| Evinacumab placebo | Drug | Administered per the protocol |
|
| Baseline to Week 24 |
| Change in High-Density Lipoprotein-Cholesterol (HDL-C) | Baseline to Week 24 |
| Change in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) | Baseline to Week 24 |
| Change in triglycerides | Baseline to Week 24 |
| Change in Apolipoprotein B (ApoB) | Baseline to Week 24 |
| Concentration of combined ALN-ANG3 and metabolite(s) and evinacumab | Up to Week 24 |
| Change in concentration of Angiopoietin-Like Protein-3 (ANGPTL-3) | Baseline to Week 24 |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Up to Week 48 |
| Severity of TEAEs | Up to Week 48 |
| Incidence of ADAs to ALN-ANG3 | Through Week 24 |
| Magnitude of ADAs to ALN-ANG3 | Through Week 24 |
| Incidence of ADAs to evinacumab | Through Week 24 |
| Magnitude of ADAs to evinacumab | Through Week 24 |
| Applied Research Center of Arkansas |
| Recruiting |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| AME Clinical Research | Recruiting | Huntington Beach | California | 92647 | United States |
| Amicis Research Center | Recruiting | Northridge | California | 91325 | United States |
| FOMAT - Vista del Mar Medical Group | Recruiting | Oxnard | California | 93036 | United States |
| Central Coast Nephrology | Recruiting | Salinas | California | 93901 | United States |
| North America Research Institute | Recruiting | San Dimas | California | 91773 | United States |
| Amicis Research Center | Recruiting | Santa Clarita | California | 91355 | United States |
| Valiance Clinical Research | Recruiting | Tarzana | California | 91356 | United States |
| Amicis Research Center | Recruiting | Valencia | California | 91355 | United States |
| National Institute of Clinical Research, Inc. | Recruiting | Victorville | California | 92392 | United States |
| D&H Doral Research Center | Recruiting | Doral | Florida | 33122 | United States |
| AGA Clinical Trials | Recruiting | Hialeah | Florida | 33012 | United States |
| Convenient Medical Center | Recruiting | Hialeah | Florida | 33013 | United States |
| Elixia Hollywood | Recruiting | Hollywood | Florida | 33024 | United States |
| D&H Pompano Research Center | Recruiting | Margate | Florida | 33063 | United States |
| LCC Medical Research Institute | Recruiting | Miami | Florida | 33126 | United States |
| D&H National Research Centers, Inc | Recruiting | Miami | Florida | 33155 | United States |
| Regenerate Primary Medical Research, LLC | Recruiting | Miami | Florida | 33155 | United States |
| Ocean Blue Medical Research Center - Internal Medicine | Recruiting | Miami Springs | Florida | 33166 | United States |
| Innovia Research Center | Recruiting | Miramar | Florida | 33027 | United States |
| Central Florida Kidney Specialists Oakwater | Recruiting | Orlando | Florida | 32806 | United States |
| Bolanos Clinical Research | Recruiting | Pembroke Pines | Florida | 33026 | United States |
| Progressive Medical Research | Recruiting | Port Orange | Florida | 32127 | United States |
| CDC Research Institute | Recruiting | Port Saint Lucie | Florida | 34952 | United States |
| D&H Tamarac Research Center | Recruiting | Tamarac | Florida | 33321 | United States |
| Metabolic Research Institute | Recruiting | West Palm Beach | Florida | 33401 | United States |
| Privia Medical Group of Georgia, LLC | Recruiting | Savannah | Georgia | 31406 | United States |
| Research by Design, LLC - Internal Medicine | Recruiting | Chicago | Illinois | 60643 | United States |
| IMA Clinical Research | Recruiting | Monroe | Louisiana | 71201 | United States |
| Elixia Michigan Kidney Consultants | Recruiting | Pontiac | Michigan | 48341 | United States |
| Elixia MNA | Recruiting | City of Saint Peters | Missouri | 63376 | United States |
| Clinical Research Consultants, LLC | Recruiting | Kansas City | Missouri | 64111 | United States |
| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
| DaVita Clinical Research | Recruiting | Las Vegas | Nevada | 89107 | United States |
| Velocity Clinical Research | Recruiting | Binghamton | New York | 13905 | United States |
| CHEAR Center LLC | Recruiting | The Bronx | New York | 10455 | United States |
| Eastern Nephrology Associates - Greenville West | Recruiting | Greenville | North Carolina | 27834 | United States |
| Eastern Nephrology Associates - New Bern | Recruiting | New Bern | North Carolina | 28562 | United States |
| Brookview Hills Research Associates, LLC | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
| Northeast Clinical Research Center | Recruiting | Bethlehem | Pennsylvania | 18017 | United States |
| Suburban Research Associates | Recruiting | West Chester | Pennsylvania | 19380 | United States |
| Southeast Renal Research Institute | Recruiting | Chattanooga | Tennessee | 37404 | United States |
| Arlington Nephrology, PLLC. | Recruiting | Arlington | Texas | 76015 | United States |
| M3 Wake Research Dallas - Internal Medicine | Recruiting | Dallas | Texas | 75224 | United States |
| Revival Research Institute, LLC | Recruiting | Dallas | Texas | 75231 | United States |
| El Paso Kidney Specialists-Davita Clinical Research | Recruiting | El Paso | Texas | 79902 | United States |
| Juno Research, LLC | Recruiting | Houston | Texas | 77040 | United States |
| Clinical Trial Network, LLC | Recruiting | Houston | Texas | 77074 | United States |
| Gulf Coast Clinical Research | Recruiting | Katy | Texas | 77450 | United States |
| R & H Clinical Research, Inc. | Recruiting | Katy | Texas | 77450 | United States |
| Sunbeam Clinical Research | Recruiting | McKinney | Texas | 75069 | United States |
| Clinical Advancement Center | Recruiting | San Antonio | Texas | 78212 | United States |
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000621590 | evinacumab |
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