Testing NNC0519-0130 Doses for Kidney Damage in Chronic Kidney Disease
Tests the medicine NNC0519-0130 against semaglutide and placebo in adults with chronic kidney disease.
Key facts
- Who runs it
- Novo Nordisk A/S
- Where
- Adana, Ankara, Gaziantep, Istanbul, Izmir, Kayseri, and Kocaeli, TürkiyeSee the 14 sitesAlso in 13 other countries, 119 sites
- Trial code
- NCT06717698
- EU 2024-510846-15-00
- U1111-1302-5591
- Registry title
- A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 465 people, planned
- Started
- 2 Dec 2024
- Planned end
- 17 Sept 2026
- Type of study
- Interventional, 9 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- NNC0519-0130
- Placebo
- Semaglutide
- Record updated
- 11 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic kidney disease and protein in the urine, with or without type 2 diabetes, who are living with overweight or obesity.
- Age
- 18 years or older.
- Sex
- Men and women can join. Women who could become pregnant can join only in the US, and only with highly effective non-systemic birth control.
- Disease stage
- Chronic kidney disease with eGFR of 15 or more and less than 90 mL/min/1.73 m^2, and albumin in the urine (UACR) of 100 or more and less than 5000 mg/g. BMI of 27.0 kg/m^2 or more.
- Earlier treatment
- Taking the highest labelled or tolerated dose of an ACE inhibitor or ARB, at a stable dose for at least 30 days before screening, unless it is not possible or not tolerated. No GLP-1 RA medicine in the 90 days before screening.
- Biomarker or test result
- HbA1c of 6.5% (48 mmol/mol) to 10.5% (48 to 91 mmol/mol) if the person has type 2 diabetes, or below 6.5% (below 48 mmol/mol) if not.
Main reasons for not taking part
- Pregnant, breast-feeding, or planning pregnancy
- Lupus nephritis or ANCA-associated vasculitis
- Immunosuppressive therapy for kidney disease in the last 6 months
- Heart attack, stroke, TIA or hospital stay for unstable angina in the last 180 days
- Dialysis in the 90 days before screening
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
Where in Türkiye
Also in 13 other countries, 119 sites
- Adana Şehir Eğitim ve Araştırma HastanesiAdana, TürkiyeContact: Novo NordiskNo longer taking part
- Ankara Sehir Hastanesi Dahiliye KlinigiAnkara, TürkiyeContact: Novo NordiskTaking people
- Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim DaliAnkara, TürkiyeContact: Novo NordiskTaking people
- Ankara Bilkent Şehir Hastanesi-DahiliyeAnkara, TürkiyeContact: Novo NordiskNo longer taking part
- Hacettepe Üniversitesi Hastanesi- NefrolojiAnkara, TürkiyeContact: Novo NordiskNo longer taking part
- Gaziantep Universitesi Tip Fakultesi HastanesiGaziantep, TürkiyeContact: Novo NordiskTaking people
- Gaziantep Üniversitesi Hastanesi- EndokrinolojiGaziantep, TürkiyeContact: Novo NordiskNo longer taking part
- T.C SB Goztepe Prof. Dr. Suleyman Yalcin City HospitalIstanbul, TürkiyeContact: Novo NordiskTaking people
- Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- DahiliyeIstanbul, TürkiyeContact: Novo NordiskNo longer taking part
- Ege Universitesi Tip Fakultesi HastanesiIzmir, TürkiyeContact: Novo NordiskTaking people
- Ege Universitesi Hastanesi- EndokrinolojiIzmir, TürkiyeContact: Novo NordiskNo longer taking part
- Erciyes Üniversitesi Hastanesi - NefrolojiKayseri, TürkiyeContact: Novo NordiskNo longer taking part
- Kocaeli University Nephrology DepartmentKocaeli, TürkiyeContact: Novo NordiskTaking people
- Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - NefrolojiKocaeli, TürkiyeContact: Novo NordiskNo longer taking part
About the trial
What the trial wants to find out
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. The study will last for up to 43 weeks.
The 9 groups in the trial
- Dosing scheme a: NNC0519-0130Treatment being tested
Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Treatment: NNC0519-0130
- Dosing scheme a: PlaceboPlacebo, for comparison
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Treatment: Placebo
- Dosing scheme b: NNC0519-0130Treatment being tested
Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Treatment: NNC0519-0130
- Dosing scheme b: PlaceboPlacebo, for comparison
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Treatment: Placebo
- Dosing scheme c: NNC0519-0130Treatment being tested
Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Treatment: NNC0519-0130
- Dosing scheme c: PlaceboPlacebo, for comparison
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Treatment: Placebo
- Dosing scheme d: NNC0519-0130Treatment being tested
Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Treatment: NNC0519-0130
- Dosing scheme d: PlaceboPlacebo, for comparison
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Treatment: Placebo
- Dosing scheme e: SemaglutideExisting treatment, for comparison
Participants will receive once-weekly s.c injections of semaglutide with a dose escalation done until maintenance dose is reached.
Treatment: Semaglutide
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Efficacy, Safety and Pharmacokinetics of NNC0519-0130 Once Weekly s.c. Versussemaglutide 1.0 mg and Placebo in People With Chronic Kidney Disease, With or Without Type 2 Diabetes, and With Overweight or Obesity: a Proof-of-concept and Dose-finding Study
- Plain-language title
- Testing NNC0519-0130 Doses for Kidney Damage in Chronic Kidney DiseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 11 March 2026