Diabetic Kidney Disease (DKD)Phase 2ANCHOR-POCNCT07271186
Study to Assess the Effects of ALN-ANG3 in Adult Participants With Diabetic Kidney Disease
A Phase 2 study testing ALN-ANG3 and Evinacumab in people with Diabetic Kidney Disease (DKD), run by Regeneron Pharmaceuticals at 59 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Kidney Disease (DKD)
- What is being tested?
- ALN-ANG3 and Evinacumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 59 sitesUnited States
- Study dates
- 9 Jan 2026to 13 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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
- Albuminuria: Urine Albumin to Creatinine Ratio (UACR) of 500 to 5000 mg/g at screening
Who cannot join
- 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
- NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Trial locations and contacts
59 sites in 1 country. Contact the study team or a site near you to ask about taking part.
59 sites in 1 country
United States59 sites, 57 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
Arlington Nephrology, PLLC.
Arlington, Texas, 76015
- Recruiting
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
- Recruiting
Velocity Clinical Research
Binghamton, New York, 13905
- Withdrawn
Southeast Renal Research Institute
Chattanooga, Tennessee, 37404
- Recruiting
Research by Design, LLC - Internal Medicine
Chicago, Illinois, 60643
- Recruiting
Elixia MNA
City of Saint Peters, Missouri, 63376
- Recruiting
M3 Wake Research Dallas - Internal Medicine
Dallas, Texas, 75224
- Recruiting
Revival Research Institute, LLC
Dallas, Texas, 75231
- Recruiting
Epic Medical Research LLC
DeSoto, Texas, 75115
- Recruiting
D&H Doral Research Center
Doral, Florida, 33122
- Recruiting
El Paso Kidney Specialists-Davita Clinical Research
El Paso, Texas, 79902
- Recruiting
Eastern Nephrology Associates - Greenville West
Greenville, North Carolina, 27834
- Recruiting
AGA Clinical Trials
Hialeah, Florida, 33012
- Recruiting
Convenient Medical Center
Hialeah, Florida, 33013
- Recruiting
Elixia Hollywood
Hollywood, Florida, 33024
- Recruiting
Juno Research, LLC
Houston, Texas, 77040
- Recruiting
Prolato Research LLC
Houston, Texas, 77054
- Recruiting
Clinical Trial Network, LLC
Houston, Texas, 77074
- Recruiting
AME Clinical Research
Huntington Beach, California, 92647
- Recruiting
Apogee Clinical Research, LLC
Huntsville, Alabama, 35801
- Recruiting
Clinical Research Consultants, LLC
Kansas City, Missouri, 64111
- Recruiting
Gulf Coast Clinical Research
Katy, Texas, 77450
- Recruiting
R & H Clinical Research, Inc.
Katy, Texas, 77450
- Recruiting
DaVita Clinical Research
Las Vegas, Nevada, 89107
- Recruiting
Applied Research Center of Arkansas
Little Rock, Arkansas, 72205
- Recruiting
D&H Pompano Research Center
Margate, Florida, 33063
- Recruiting
Sunbeam Clinical Research
McKinney, Texas, 75069
- Recruiting
LCC Medical Research Institute
Miami, Florida, 33126
- Recruiting
D&H National Research Centers, Inc
Miami, Florida, 33155
- Recruiting
Regenerate Primary Medical Research, LLC
Miami, Florida, 33155
- Recruiting
Ocean Blue Medical Research Center - Internal Medicine
Miami Springs, Florida, 33166
- Recruiting
Innovia Research Center
Miramar, Florida, 33027
- Recruiting
IMA Clinical Research
Monroe, Louisiana, 71201
- Recruiting
Eastern Nephrology Associates - New Bern
New Bern, North Carolina, 28562
- Recruiting
Yale University
New Haven, Connecticut, 06510
- Recruiting
Amicis Research Center
Northridge, California, 91325
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Recruiting
Central Florida Kidney Specialists Oakwater
Orlando, Florida, 32806
- Recruiting
FOMAT - Vista del Mar Medical Group
Oxnard, California, 93036
- Recruiting
Bolanos Clinical Research
Pembroke Pines, Florida, 33026
- Recruiting
Elixia Michigan Kidney Consultants
Pontiac, Michigan, 48341
- Recruiting
Progressive Medical Research
Port Orange, Florida, 32127
- Recruiting
CDC Research Institute
Port Saint Lucie, Florida, 34952
- Withdrawn
Central Coast Nephrology
Salinas, California, 93901
- Recruiting
Clinical Advancement Center
San Antonio, Texas, 78212
- Recruiting
University of Texas Health - San Antonio
San Antonio, Texas, 78229
- Recruiting
North America Research Institute
San Dimas, California, 91773
- Recruiting
Amicis Research Center
Santa Clarita, California, 91355
- Recruiting
Privia Medical Group of Georgia, LLC
Savannah, Georgia, 31406
- Recruiting
Providence Medical Research Center
Spokane, Washington, 99204
- Recruiting
D&H Tamarac Research Center
Tamarac, Florida, 33321
- Recruiting
Valiance Clinical Research
Tarzana, California, 91356
- Recruiting
CHEAR Center LLC
The Bronx, New York, 10455
- Recruiting
Amicis Research Center
Valencia, California, 91355
- Recruiting
National Institute of Clinical Research, Inc.
Victorville, California, 92392
- Recruiting
Suburban Research Associates
West Chester, Pennsylvania, 19380
- Recruiting
Metabolic Research Institute
West Palm Beach, Florida, 33401
- Recruiting
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: 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
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
- Conditions
- Diabetic Kidney Disease (DKD)
- Being tested
- ALN-ANG3, Evinacumab, Placebo
- Keywords
- Diabetic Nephropathy, Chronic Kidney Disease (CKD), Type 2 Diabetes, Lipid Management, Renal Impairment, Gene Silencing, siRNA, small-interfering RNA
- Medical subject headings
- Diabetic Nephropathies, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALN-ANG3Drug
Administered per the protocol
EvinacumabDrug
Also called Evkeeza®, R1500
No longer being administered
PlaceboDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| ALN-ANG3 + evinacumab | Experimental | This arm has been closed Receives: Drug: ALN-ANG3; Drug: Evinacumab |
| ALN-ANG3 | Experimental | Not described Receives: Drug: ALN-ANG3 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Urine Albumin to Creatinine Ratio (UACR)
Measured: Baseline to Week 24
Secondary outcomes (13)
Change in Estimated Glomerular Filtration Rate (eGFR)
Measured: Baseline to Week 24
Change in Total Cholesterol
Measured: Baseline to Week 24
Change in Low-Density Lipoprotein-Cholesterol (LDL-C)
Measured: Baseline to Week 24
Change in High-Density Lipoprotein-Cholesterol (HDL-C)
Measured: Baseline to Week 24
Change in Non-High-Density Lipoprotein-Cholesterol (non-HDL-C)
Measured: Baseline to Week 24
Change in Triglycerides
Measured: Baseline to Week 24
Change in Apolipoprotein B (ApoB)
Measured: Baseline to Week 24
Concentration of Combined ALN-ANG3 and Metabolite(s)
Measured: Up to Week 24
Change in Concentration of Angiopoietin-Like Protein-3 (ANGPTL-3)
Measured: Baseline to Week 24
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Week 48
Severity of TEAEs
Measured: Up to Week 48
Occurence of Anti-Drug Antibodies (ADAs) to ALN-ANG3
Measured: Through Week 24
Magnitude of ADAs to ALN-ANG3
Measured: Through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start9 Jan 2026
- Primary completion13 Oct 2028 (estimated)
- Study completion13 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney Disease (DKD)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271186
- Sponsor's protocol ID
- ALN-ANG3-CKD-2502
- Other IDs
- 2026-527519-41-00
- Acronym
- ANCHOR-POC
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07271186
- Acronym / sponsor ID
- ANCHOR-POC / ALN-ANG3-CKD-2502
- Conditions
- Diabetic Kidney Disease (DKD)
- Keywords
- Diabetic Nephropathy, Chronic Kidney Disease (CKD), Type 2 Diabetes, Lipid Management, Renal Impairment, Gene Silencing, siRNA, small-interfering RNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 13 Oct 2028 (estimated)
- Study completion
- 13 Oct 2028 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALN-ANG3 + evinacumab | Experimental | Drug: ALN-ANG3, Drug: EvinacumabThis arm has been closed |
| ALN-ANG3 | Experimental | Drug: ALN-ANG3 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 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
- Albuminuria: Urine Albumin to Creatinine Ratio (UACR) of 500 to 5000 mg/g at screening
Key exclusion criteria (4 listed)
- 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
- NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALN-ANG3Administered per the protocol | Drug | ALN-ANG3, ALN-ANG3 + evinacumab |
| EvinacumabAlso: Evkeeza®, R1500No longer being administered | Drug | ALN-ANG3 + evinacumab |
| PlaceboAdministered per the protocol | Drug | Placebo |
Primary outcome
Percent Change in Urine Albumin to Creatinine Ratio (UACR)
Time frame: Baseline to Week 24
13 secondary outcomes
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline to Week 24
Change in Total Cholesterol
Time frame: Baseline to Week 24
Change in Low-Density Lipoprotein-Cholesterol (LDL-C)
Time frame: Baseline to Week 24
Change in High-Density Lipoprotein-Cholesterol (HDL-C)
Time frame: Baseline to Week 24
Change in Non-High-Density Lipoprotein-Cholesterol (non-HDL-C)
Time frame: Baseline to Week 24
Change in Triglycerides
Time frame: Baseline to Week 24
Change in Apolipoprotein B (ApoB)
Time frame: Baseline to Week 24
Concentration of Combined ALN-ANG3 and Metabolite(s)
Time frame: Up to Week 24
Change in Concentration of Angiopoietin-Like Protein-3 (ANGPTL-3)
Time frame: Baseline to Week 24
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 48
Severity of TEAEs
Time frame: Up to Week 48
Occurence of Anti-Drug Antibodies (ADAs) to ALN-ANG3
Time frame: Through Week 24
Magnitude of ADAs to ALN-ANG3
Time frame: Through Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
59 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALN-ANG3 and Evinacumab in people with Diabetic Kidney Disease (DKD), run by Regeneron Pharmaceuticals at 59 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Urine Albumin to Creatinine Ratio (UACR) (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.