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

JRCT ID: jRCT2031240497

Registered date:20/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic kidney disease with overweight or obesity
• Date of first enrollment: 02/12/2024
• Target sample size: 45
• Countries of recruitment: Argentina,Japan,Brazil,Japan,Bulgaria,Japan,Czechia,Japan,India,Japan,Italy,Japan,Korea,Japan,Malaysia,Japan,Poland,Japan,Spain,Japan,Turkiye,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

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) subcutaneously (s.c.) administered NNC0519-0130 (a dual glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like-peptide 1 (GLP-1) receptor agonist (RA)) and the corresponding volume-matched placebo arms. The active comparator arm with semaglutide will be open label.
The study consists of:
- an up to 3-week screening period (randomisation takes place at visit 3 (V3), week 0)
- a 36-week intervention period
- including an up to 24 weeks dose escalation period followed by
- 12 weeks on a maintenance dose
- a 4-week follow-up period.
Safety, PK and efficacy data will be collected at regular intervals throughout the study.
After a screening period of up to 3 weeks, approximately 456 participants will be randomised in a 4:1:4:1:4:1:4:1:4 ratio to 9 arms consisting of 4 active treatment (NNC0519-0130) arms with 4 corresponding volume-matched placebo arms and one active comparator (semaglutide) arm.
Randomisation will be stratified according to diagnosis of T2D at screening and, within the group with T2D, SGLT2 inhibitor use at screening.

Outcome(s)

• Primary Outcome: To demonstrate and characterise the dose-response relationship of QW s.c. NNC0519-0130 with respect to relative reduction in UACR

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Sato Yohei