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Research Study for Chronic Kidney Disease with NNC0519-0130

This research study is looking at how well different doses of a medicine called NNC0519-0130 can help people with chronic kidney disease. It also checks the safety of NNC0519-0130. Some participants may also have type 2 diabetes or be overweight/obese. You would receive NNC0519-0130, semaglutide (another medicine), or a placebo (an inactive substance). Which one you get is decided by chance. Doctors will measure changes in your urine (urinary albumin-to-creatinine ratio or UACR) at 12, 24, and 36 weeks to see if the treatments are working. The study is for adults aged 18 and older. The study plans to enroll 465 people, but its current status is unclear.

Study design
This is an interventional study comparing different doses of NNC0519-0130, semaglutide, and a placebo. Approximately 465 participants are planned to be enrolled.
What's involved
The study will last for up to 43 weeks. You will receive NNC0519-0130, semaglutide, or placebo administered subcutaneously (under the skin).
Compensation
Not stated in the trial record.
Follow-up
Your kidney function will be monitored at weeks 12, 24, and 36.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06717698

A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease

Recruiting
PHASE2Ages 18+InterventionalTreatment
Novo Nordisk A/S
~465 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:NNC0519-0130PlaceboSemaglutide

At a glance

Recruiting sites
16 of 147 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in urinary albumin-to-creatinine ratio (UACR) at week 12
Measured over From baseline (week 0) to end of a given maintenance dose period (week 12)
+2 more outcomes measured

Conditions

Chronic Kidney Disease

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Chronic Kidney Disease

NCT06717698

Where you'd take part

This study runs at 147 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ankara Sehir Hastanesi Dahiliye Klinigi

    Ankara, Turkey (Türkiye)no site contact published

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello

    Pisa, Italyno site contact published

    Not yet recruiting

  • Clínica Nuevas Tecnologías en Diabetes y Endocrinología

    Seville, Spainno site contact published

    Not yet recruiting

  • Diabetes Research Center, Hyderabad

    Hyderabad, Telangana, Indiano site contact published

    Not yet recruiting

  • Diabetes, Thyroid and Endocrine Centre

    Jaipur, Rajasthan, Indiano site contact published

    Not yet recruiting

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, Turkey (Türkiye)no site contact published

    Recruiting

  • Endolife Specialty Hospitals

    Guntur, Andhra Pradesh, Indiano site contact published

    Not yet recruiting

  • Formed 2 Sp. z o.o.

    Oświęcim, Polandno site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Transparency (dept. 2834) · STUDY_DIRECTOR · Novo Nordisk A/S

Who to contact

Novo Nordisk
[email protected]
(+1) 866-867-7178
Email the study team

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Eligibility criteria

Inclusion

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 than (\<) 90 mL/min/1.73 m\^2.
Albuminuria defined by Urine Albumin-to-Creatinine Ratio (UACR) greater than or equal (≥)100 and less than (\<) 5000 milligram per gram (mg/g).
Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening.

Exclusion

Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective non-systemic contraception with low user-dependency.
Lupus nephritis or antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
Receiving immunosuppressive therapy for primary or secondary renal disease within 6 months prior to screening.
Use of any glucagon-like peptide-1 (GLP-1) RA (including medication with GLP-1 RA activity, e.g., GIP/GLP-1 RA) within 90 days prior to screening.
Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 180 days before screening.
Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
Only applicable for participants with type 2 diabetes (T2D): Uncontrolled and potentially unstable diabetic retinopathy or diabetic maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN)) within 5 years before screening.

What this trial measures

  • Change in urinary albumin-to-creatinine ratio (UACR) at week 12From 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 24From 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 36From baseline (week 0) to end of a given maintenance dose period (week 36)

    Measured as a ratio to baseline.