Chronic kidney disease with overweight or obesity
Conditions
Interventions
This is an interventional, multi-national, multi-centre, randomised, 9-armed, proof-of-concept, and
dose-finding, phase II study. The study will be double-blinded within dose level of once weekly (QW)
Sponsors
Sato Yohei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 = 27.0 kg/m2 at screening. - Kidney impairment defined by serum creatinine and cystatin C-based eGFR >= 15 and = 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.
Exclusion criteria
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 enrolment. - Use of any 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 T2D: Uncontrolled and potentially unstable diabetic retinopathy or 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 |
|---|---|
| To demonstrate and characterise the dose-response relationship of QW s.c. NNC0519-0130 with respect to relative reduction in UACR | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Italy, Japan, Korea, Malaysia, Poland, Spain, Turkiye, United States
Contacts
Public Contactclinical trial information person in charge of registering
Novo Nordisk Pharma Ltd.
Outcome results
None listed