Chronic Kidney Disease
Conditions
Brief 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.
Interventions
DRUGNNC0519-0130
NNC0519-0130 will be administered subcutaneously.
DRUGPlacebo
Placebo matching NNC0519-0130 will be administered subcutaneously.
DRUGSemaglutide
Semaglutide will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in urinary albumin-to-creatinine ratio (UACR) at week 12 | 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 | 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 | From baseline (week 0) to end of a given maintenance dose period (week 36) | Measured as a ratio to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021) | From baseline (week 0) to end of treatment (week 36) | Measured in mililitre per minute per 1.73 square metre (mL/min/1.73 m\^2). |
| Change in estimated glomerular filtration rate (eGFR) (creatinine-based CKD-EPI 2021) | From baseline (week 0) to end of treatment (week 36) | Measured in mililitre per minute per 1.73 square metre (mL/min/1.73 m\^2). |
| Relative change in body weight | From baseline (week 0) to end of treatment (week 36) | Measured in percentage (%). |
| Achievement of greater than or equal to (≥) 5 percentage (%) weight reduction | From baseline (week 0) to end of treatment (week 36) | Measured as count of participants. |
| Achievement of greater than or equal to (≥) 10 percentage (%) weight reduction | From baseline (week 0) to end of treatment (week 36) | Measured as count of participants. |
| Change in waist circumference | From baseline (week 0) to end of treatment (week 36) | Measured in centimetres (cm). |
| Change in glycated haemoglobin (HbA1c) | From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36) | Measured in percentage point (%-point). |
| Change in systolic blood pressure | From baseline (week 0) to end of treatment (week 36) | Measured in millimetres of mercury (mmHg). |
| Change in diastolic blood pressure | From baseline (week 0) to end of treatment (week 36) | Measured in millimetres of mercury (mmHg). |
| Number of treatment emergent adverse events (TEAEs) | From baseline (week 0) to end of study (week 40) | Measured as count of events. |
Countries
Argentina, Australia, Brazil, Bulgaria, Czechia, India, Italy, Japan, Malaysia, Poland, South Korea, Spain, Turkey (Türkiye), United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed