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A research study comparing how well different doses of the medicine NNC0519-0130 can reduce kidney damage in people living with chronic kidney disease.
EU CTIS ID: 2024-510846-15-00
What this study is testing
To demonstrate and characterise the dose-response relationship of once weekly (QW) s.c. NNC0519-0130 with respect to relative reduction in urinary albumin-to-creatinine ratio (UACR)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female of non-childbearing potential or male.
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening, or not diagnosed with type 2 diabetes mellitus.
- HbA1c of 6.5% -10.5% [48 – 91 mmol/mol] (both inclusive) if diagnosed with type 2 diabetes mellitus, or HbA1c of <6.5% [<48 mmol/mol] if not diagnosed with type 2 diabetes mellitus.
- BMI ≥ 27.0 kg/m2 at screening.
- Kidney impairment defined by serum creatinine and cystatin C-based eGFR ≥ 15 and < 90 mL/min/1.73 m2.
You likely can't join if
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using effective contraceptive method.
- Polycystic kidney disease, lupus nephritis, ANCA-associated vasculitis. Receiving immunosuppressive therapy for primary or secondary renal disease within 6 months prior to enrolment.
- Use of any GLP-1RA (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.
- Uncontrolled and potentially unstable diabetic retinopathy or diabetic maculopathy. Verified by a fundus 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.
See the full eligibility criteria
- Female of non-childbearing potential or male.
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening, or not diagnosed with type 2 diabetes mellitus.
- HbA1c of 6.5% -10.5% [48 – 91 mmol/mol] (both inclusive) if diagnosed with type 2 diabetes mellitus, or HbA1c of <6.5% [<48 mmol/mol] if not diagnosed with type 2 diabetes mellitus.
- BMI ≥ 27.0 kg/m2 at screening.
- Kidney impairment defined by serum creatinine and cystatin C-based eGFR ≥ 15 and < 90 mL/min/1.73 m2.
- Albuminuria defined by UACR ≥ 100 and < 5000 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.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using effective contraceptive method.
- Polycystic kidney disease, lupus nephritis, ANCA-associated vasculitis. Receiving immunosuppressive therapy for primary or secondary renal disease within 6 months prior to enrolment.
- Use of any GLP-1RA (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.
- Uncontrolled and potentially unstable diabetic retinopathy or diabetic maculopathy. Verified by a fundus 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Turkey
- Korea, Republic of
- Japan
- Argentina
- Malaysia
- Brazil
- Australia
- India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Turkey; Korea, Republic of; Japan; Argentina; Malaysia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.