A research study comparing how well different doses of the medicine NNC0519-0130 can reduce kidney damage in people living with chronic kidney disease.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novo Nordisk A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify, Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

14 Apr 2025 → ongoing

Decision date (initial)

2024-12-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2024-510846-15-00

WHO UTN

U1111-1302-5591

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic

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)

Secondary objectives 1

1. To compare the effect of once weekly (QW) s.c. NNC0519-0130 versus placebo with respect to: Surrogate markers of CKD progression, Weight related parameters, Glycaemic control, Blood pressure, Safety and tolerability

Conditions and MedDRA coding

Chronic Kidney Disease, with or without Type 2 diabetes, Obesity

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Female of non-childbearing potential or male.
2. Age 18 years or above at the time of signing the informed consent.
3. Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening, or not diagnosed with type 2 diabetes mellitus.
4. 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.
5. BMI ≥ 27.0 kg/m2 at screening.
6. Kidney impairment defined by serum creatinine and cystatin C-based eGFR ≥ 15 and < 90 mL/min/1.73 m2.
7. Albuminuria defined by UACR ≥ 100 and < 5000 mg/g.
8. 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 7

1. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using effective contraceptive method.
2. Polycystic kidney disease, lupus nephritis, ANCA-associated vasculitis. Receiving immunosuppressive therapy for primary or secondary renal disease within 6 months prior to enrolment.
3. Use of any GLP-1RA (including medication with GLP-1 RA activity, e.g., GIP/GLP-1 RA) within 90 days prior to screening.
4. Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 180 days before screening.
5. Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
6. 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.
7. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in UACR From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)

Secondary endpoints 10

1. Change in eGFR (creatinine and cystatin C-based CKD-EPI 2021) from baseline to end of treatment
2. Change in eGFR (creatinine-based CKD-EPI 2021)  from baseline to end of treatment
3. Relative change in body weight from baseline to end of treatment
4. Achievement of ≥ 5 % weight reduction from baseline to end of treatment
5. Achievement of ≥ 10 % weight reduction from baseline to end of treatment
6. Change in waist circumference from baseline to end of treatment
7. Change in glycated haemoglobin (HbA1c) from baseline to end of a given maintenance dose period (week 12, 24 or 36)
8. Change in systolic blood pressure from baseline to end of treatment
9. Change in diastolic blood pressure from baseline to end of treatment
10. Number of treatment emergent adverse events (TEAEs) from baseline to end of study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novo Nordisk A/S

Sponsor organisation

Novo Nordisk A/S

Address

Novo Alle 1

City

Bagsvaerd

Postcode

2880

Country

Denmark

Scientific contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Public contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Third parties 12

Locations

4 EU/EEA countries · 39 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 46 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications