NNC0519-0130 for Chronic kidney disease | Type 2 diabetes mellitus | Obesity

Inclusion criteria

• {"criterion_text":"- Female of non-childbearing potential or male."}
• {"criterion_text":"- Age 18 years or above at the time of signing the informed consent."}
• {"criterion_text":"- Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening, or not diagnosed with type 2 diabetes mellitus."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- BMI ≥ 27.0 kg/m2 at screening."}
• {"criterion_text":"- Kidney impairment defined by serum creatinine and cystatin C-based eGFR ≥ 15 and < 90 mL/min/1.73 m2."}
• {"criterion_text":"- Albuminuria defined by UACR ≥ 100 and < 5000 mg/g."}
• {"criterion_text":"- 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

• {"criterion_text":"- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using effective contraceptive method."}
• {"criterion_text":"- Polycystic kidney disease, lupus nephritis, ANCA-associated vasculitis. Receiving immunosuppressive therapy for primary or secondary renal disease within 6 months prior to enrolment."}
• {"criterion_text":"- Use of any GLP-1RA (including medication with GLP-1 RA activity, e.g., GIP/GLP-1 RA) within 90 days prior to screening."}
• {"criterion_text":"- Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 180 days before screening."}
• {"criterion_text":"- Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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 endpoints

• {"endpoint_text":"- Change in UACR From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)","definition_or_measurement_approach":"Change in urinary albumin-to-creatinine ratio (UACR) from baseline (week 0) to end of maintenance dose periods (week 12, 24 or 36); objective described as demonstrating and characterising dose-response in relative reduction in UACR."}

Secondary endpoints

• {"endpoint_text":"- Change in eGFR (creatinine and cystatin C-based CKD-EPI 2021) from baseline to end of treatment","definition_or_measurement_approach":"Change in estimated glomerular filtration rate (eGFR) calculated using creatinine and cystatin C via CKD-EPI 2021 from baseline to end of treatment."}
• {"endpoint_text":"- Change in eGFR (creatinine-based CKD-EPI 2021) from baseline to end of treatment","definition_or_measurement_approach":"Change in eGFR calculated using creatinine-based CKD-EPI 2021 from baseline to end of treatment."}
• {"endpoint_text":"- Relative change in body weight from baseline to end of treatment","definition_or_measurement_approach":"Relative (%) change in body weight from baseline to end of treatment."}
• {"endpoint_text":"- Achievement of ≥ 5 % weight reduction from baseline to end of treatment","definition_or_measurement_approach":"Proportion of participants achieving ≥5% weight reduction from baseline to end of treatment."}
• {"endpoint_text":"- Achievement of ≥ 10 % weight reduction from baseline to end of treatment","definition_or_measurement_approach":"Proportion of participants achieving ≥10% weight reduction from baseline to end of treatment."}
• {"endpoint_text":"- Change in waist circumference from baseline to end of treatment","definition_or_measurement_approach":"Change in waist circumference from baseline to end of treatment."}
• {"endpoint_text":"- Change in glycated haemoglobin (HbA1c) from baseline to end of a given maintenance dose period (week 12, 24 or 36)","definition_or_measurement_approach":"Change in HbA1c from baseline to end of maintenance dose periods (week 12, 24 or 36)."}
• {"endpoint_text":"- Change in systolic blood pressure from baseline to end of treatment","definition_or_measurement_approach":"Change in systolic blood pressure from baseline to end of treatment."}
• {"endpoint_text":"- Change in diastolic blood pressure from baseline to end of treatment","definition_or_measurement_approach":"Change in diastolic blood pressure from baseline to end of treatment."}
• {"endpoint_text":"- Number of treatment emergent adverse events (TEAEs) from baseline to end of study","definition_or_measurement_approach":"Count and classification of treatment-emergent adverse events from baseline to end of study."}

Bulgaria

Earliest CTIS Part Ii Submission Date

20-11-2024

Latest Decision Or Authorization Date

02-12-2024

Processing Time Days

12

Number Of Sites

8

Number Of Participants

30

Italy

Earliest CTIS Part Ii Submission Date

30-08-2024

Latest Decision Or Authorization Date

02-12-2024

Processing Time Days

94

Number Of Sites

8

Number Of Participants

30

Poland

Earliest CTIS Part Ii Submission Date

29-10-2024

Latest Decision Or Authorization Date

02-12-2024

Processing Time Days

34

Number Of Sites

15

Number Of Participants

30

Spain

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

26-11-2024

Processing Time Days

67

Number Of Sites

8

Number Of Participants

30

Primary sponsor

Full Name

Novo Nordisk A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Central Laboratory and Event Adjudication

Name

Celerion Switzerland AG

Responsibilities

Special Laboratory (NNC0519-0130 plasma concentration, Sema-GLP-1 plasma concentration, F2-isoprostane, Leptin, Soluble Leptin Receptor)

Name

4G Clinical B.V.

Responsibilities

RTSM supplier

Third parties

• {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"Special Laboratory (NNC0519-0130 plasma concentration, Sema-GLP-1 plasma concentration, F2-isoprostane, Leptin, Soluble Leptin Receptor)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Central Laboratory","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"Abbott GmbH","duties_or_roles":"Blood Glucose Meter supplier","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Certe Medische Diagnostiek en Advies Stichting","duties_or_roles":"Special Laboratory (Tryptase)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"CRF supplier","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Central Translation of Participant Materials","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"Special Laboratory (8-oxo- 2’deoxyguanosine (8OHdG))","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Electrocardiogram (ECG) supplier and ePRO supplier","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"Special Laboratory (Pro-C3, Pro-C6, CTX-III, C3M)","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Central Laboratory and Event Adjudication","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM supplier","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"Special Laboratory (MMP-7)","organisation_type":"Laboratory/Research/Testing facility"}