NCT06717698 · Novo Nordisk A/S
A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease
What this study is about
The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in participants with chronic kidney disease with or without type 2 diabetes, living with overweight or obesity.
View original scientific description
The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in participants with chronic kidney disease with or without type 2 diabetes, living with overweight or obesity. The participants will either get NNC0519-0130 (a new medicine), semaglutide (a medicine that doctors can already prescribe), or placebo (a "dummy" substance). Which treatment the participant will get is decided by chance.
Interventions
DRUG
NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
DRUG
Placebo
Placebo matching NNC0519-0130 will be administered subcutaneously.
DRUG
Semaglutide
Semaglutide will be administered subcutaneously.
Primary outcome measures
Change in urinary albumin-to-creatinine ratio (UACR) at week 12
Time frame: From baseline (week 0) to end of a given maintenance dose period (week 12)
Measured as a ratio to baseline.
Change in urinary albumin-to-creatinine ratio (UACR) at week 24
Time frame: From baseline (week 0) to end of a given maintenance dose period (week 24)
Measured as a ratio to baseline.
Change in urinary albumin-to-creatinine ratio (UACR) at week 36
Time frame: From baseline (week 0) to end of a given maintenance dose period (week 36)
Measured as a ratio to baseline.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Female of non-childbearing potential, or male.
- For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male.
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening, or not diagnosed with type 2 diabetes mellitus.
- HbA1c of 6.5 percentage (%)-10.5 percentage (%) \[48 - 91 millimoles per mole (mmol/mol)\] (both inclusive) if diagnosed with type 2 diabetes mellitus, or HbA1c of less than (\<)6.5 percentage (%) \[\<48 mmol/mol\] if not diagnosed with type 2 diabetes mellitus.
- BMI greater than or equal to (≥) 27.0 kilogram per square metre (kg/m\^2) at screening.
- Kidney impairment defined by serum creatinine and cystatin C-based Egfr greater than or equal to (≥) 15 and less
Where
- San Dimas, California
- San Ramon, California
- Aurora, Colorado
- Fleming Island, Florida
- Hollywood, Florida
- Saint Augustine, Florida
- Winter Haven, Florida
- Skokie, Illinois
- Valparaiso, Indiana
- Flint, Michigan
- Kansas City, Missouri
- Albany, New York
And 5 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations