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Clinical Trials in Italy / NCT06717698
Recruiting Phase 2

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

NCT06717698 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2024-12-02
Last updated
2026-03-11

Condition(s) studied

Chronic Kidney Disease

Investigational drug(s) / intervention(s)

NNC0519-0130PlaceboSemaglutide →

NNC0519-0130: NNC0519-0130 will be administered subcutaneously.

Placebo: Placebo matching NNC0519-0130 will be administered subcutaneously.

Semaglutide: Semaglutide will be administered subcutaneously.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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 Criteria: * 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.

Primary outcome measure(s)

Trial sites (147)

FacilityCityRegionStatus
N America Res Inst - San Dimas San Dimas California Active Not Recruiting
NorCal Endocrinology and Internal Medicine San Ramon California Active Not Recruiting
Rocky Mount Reg VA Med-DN Aurora Colorado Completed
Northeast Research Institute Fleming Island Florida Active Not Recruiting
Encore Medical Research LLC Hollywood Florida Active Not Recruiting
Northeast Research Institute Saint Augustine Florida Active Not Recruiting
Clinical Research of Cent FL Winter Haven Florida Completed
Endeavor Health Skokie Illinois Completed
Velocity Clin. Res Valparaiso Valparaiso Indiana Active Not Recruiting
Elite Research Center Flint Michigan Completed
Clinical Research Consultants Kansas City Missouri Active Not Recruiting
Albany Medical College Albany New York Active Not Recruiting
Carteret Medical Group Morehead City North Carolina Active Not Recruiting
Brookview Hills Research Associates, LLC Winston-Salem North Carolina Active Not Recruiting
Davita Clinical Research El Paso Texas Active Not Recruiting
Clinical Advancement Center San Antonio Texas Active Not Recruiting
Tekton Research San Antonio Texas Completed
Providence Medical Research Center Spokane Washington Active Not Recruiting
Centro Médico CIMEL Lanús Este Buenos Aires Active Not Recruiting
Renalida Mar del Plata Buenos Aires Active Not Recruiting
Centro de Investigaciones Metabólicas City of Buenos Aires Argentina Active Not Recruiting
Instituto de Cardiología de Corrientes Corrientes Argentina Active Not Recruiting
Instituto de Investigaciones Clinicas Mar Del Plata Mar del Plata Argentina Active Not Recruiting
Castle Hill Medical Centre Castle Hill New South Wales Active Not Recruiting
Gosford Renal Research Gosford New South Wales Active Not Recruiting
Heart of Australia Chelmer Queensland Active Not Recruiting
Melbourne Renal Research Group Reservoir Victoria Not Yet Recruiting
Sunshine Hospital - Western Centre for Health Research and Education St Albans Victoria Active Not Recruiting
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV Curitiba Paraná Active Not Recruiting
Instituto Pró-Renal Brasil Curitiba Paraná Active Not Recruiting
Centro de Diabetes Curitiba Curitiba Paraná Active Not Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre Porto Alegre Rio Grande do Sul Active Not Recruiting
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda. Porto Alegre Rio Grande do Sul Active Not Recruiting
Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos São Paulo Brazil Active Not Recruiting
SRH - Zdrave EAD Bankya Bulgaria Active Not Recruiting
Medical centre Zdrave 1 OOD Kozloduy Bulgaria Active Not Recruiting
Nader Yabrudi - ASMPVBE Individual practice Smolyan Bulgaria Active Not Recruiting
Medical Centre Acad. Iv. Penchev EOOD Sofia Bulgaria Completed
Medical Centre Acad. Iv. Penchev EOOD Sofia Bulgaria Active Not Recruiting
USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology Sofia Bulgaria Active Not Recruiting

+ 107 more sites — see the full list on the official registry below.

On this site

📄 Ozempic (semaglutide) drug profile →

More Novo Nordisk A/S trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06717698 on ClinicalTrials.gov ↗ ← All trials in Italy