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 now · Phase 2 · Has a placebo group

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID: NCT06717698
Run by: Novo Nordisk A/S
People needed: 465
Starts: 2024-12-02
Expected to finish: 2026-09-17
Last updated by the study team: 2026-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Ege Universitesi Tip Fakultesi Hastanesi — Izmir, Turkey (Türkiye) (enrolling)
Omihachiman Community Medical Center_Nephrology — Siga, Japan (enrolling)
Kato Clinic of Internal Medicine — Tokyo, Japan (enrolling)
T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital — Istanbul, Turkey (Türkiye) (enrolling)
Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali — Ankara, Turkey (Türkiye) (enrolling)
Fukuwa Clinic_Internal Medicine — Tokyo, Japan (enrolling)
Shinden Higashi Clinic — Sendai-shi, Miyagi, Japan (enrolling)
Fukuwa Clinic — Tokyo, Japan (enrolling)
Terpa Sp. z o.o. Sp. k. — Lublin, Poland (enrolling)
Gaziantep Universitesi Tip Fakultesi Hastanesi — Gaziantep, Turkey (Türkiye) (enrolling)
Kocaeli University Nephrology Department — Kocaeli, Turkey (Türkiye) (enrolling)
Ankara Sehir Hastanesi Dahiliye Klinigi — Ankara, Turkey (Türkiye) (enrolling)
Uniwersytecki Szpital Kliniczny w Bialymstoku — Bialystok, Poland (enrolling)
University Malaya Medical Centre — Kuala Lumpur, Kuala Lumpur, Malaysia (enrolling)
Naka Kinen Clinic_Internal medicine — Ibaraki, Japan (enrolling)
Fujisawa City Hospital_Kidney internal medicine — Kanagawa, Japan (enrolling)
Davita Clinical Research — El Paso, Texas, United States
Brookview Hills Research Associates, LLC — Winston-Salem, North Carolina, United States
Clinical Research of Cent FL — Winter Haven, Florida, United States
Carteret Medical Group — Morehead City, North Carolina, United States
Castle Hill Medical Centre — Castle Hill, New South Wales, Australia
Albany Medical College — Albany, New York, United States
Northeast Research Institute — Saint Augustine, Florida, United States
Gosford Renal Research — Gosford, New South Wales, Australia
Rocky Mount Reg VA Med-DN — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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