A Phase 2 interventional study of ALN-ANG3 and Evinacumab in Diabetic Kidney Disease (DKD), sponsored by Regeneron Pharmaceuticals. Recruiting at 59 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment
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:
543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.
This study's planned enrollment of 195 is above the median of 78 across 388 interventional studies indexed under Diabetic Nephropathies.
Browse Diabetic Nephropathies studies →Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm has been closed
Drug: ALN-ANG3 · Drug: Evinacumab
Drug: ALN-ANG3
Drug: Placebo
Administered per the protocol
No longer being administered
Also known as: Evkeeza®, R1500
Administered per the protocol
Percent Change in Urine Albumin to Creatinine Ratio (UACR)
Time frame: Baseline to Week 24
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
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy
Access criteria: 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
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Oct 2028, 33 months after the start.
Of 32 industry-sponsored phase 2 interventional studies under Diabetic Nephropathies, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 28. This study's planned 33 months is above that.
Counting every sponsor, half of 52 studies reached it within 21 months; a quarter within 13 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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