A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease

Novo Nordisk

Status and phase: Not yet enrolling; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Drug: Placebo; Drug: Semaglutide; Drug: NNC0519-0130

Study type: Interventional

Funder types: Industry

Identifiers

NCT06717698

U1111-1302-5591 (Other Identifier)

NN9541-7841

2024-510846-15 (Other Identifier)

Details and patient eligibility

About

The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in participants with chronic kidney disease with or without type 2 diabetes, living with overweight or obesity. The participants will either get NNC0519-0130 (a new medicine), semaglutide (a medicine that doctors can already prescribe), or placebo (a "dummy" substance). Which treatment the participant will get is decided by chance. The study will last for up to 43 weeks.

Enrollment: 465 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female of non-childbearing potential, or male.

  • For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male.

• Age 18 years or above at the time of signing the informed consent.

• Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening, or not diagnosed with type 2 diabetes mellitus.

  • HbA1c of 6.5 percentage (%)-10.5 percentage (%) [48 - 91 millimoles per mole (mmol/mol)] (both inclusive) if diagnosed with type 2 diabetes mellitus, or HbA1c of less than (<)6.5 percentage (%) [<48 mmol/mol] if not diagnosed with type 2 diabetes mellitus.

• BMI greater than or equal to (≥) 27.0 kilogram per square metre (kg/m^2) at screening.

• Kidney impairment defined by serum creatinine and cystatin C-based Egfr greater than or equal to (≥) 15 and less than (<) 90 mL/min/1.73 m^2.

• Albuminuria defined by Urine Albumin-to-Creatinine Ratio (UACR) greater than or equal (≥)100 and less than (<) 5000 milligram per gram (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

• 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 glucagon-like peptide-1 (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 type 2 diabetes (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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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465 participants in 9 patient groups, including a placebo group

Dosing scheme a: NNC0519-0130

Experimental group

Description:

Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Treatment:

Drug: NNC0519-0130

Dosing scheme a: Placebo

Placebo Comparator group

Description:

Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Treatment:

Drug: Placebo

Dosing scheme b: NNC0519-0130

Experimental group

Description:

Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Treatment:

Drug: NNC0519-0130

Dosing scheme b: Placebo

Placebo Comparator group

Description:

Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Treatment:

Drug: Placebo

Dosing scheme c: NNC0519-0130

Experimental group

Description:

Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Treatment:

Drug: NNC0519-0130

Dosing scheme c: Placebo

Placebo Comparator group

Description:

Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Treatment:

Drug: Placebo

Dosing scheme d: NNC0519-0130

Experimental group

Description:

Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Treatment:

Drug: NNC0519-0130

Dosing scheme d: Placebo

Placebo Comparator group

Description:

Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Treatment:

Drug: Placebo

Dosing scheme e: Semaglutide

Active Comparator group

Description:

Participants will receive once-weekly s.c injections of semaglutide with a dose escalation done until maintenance dose is reached.

Treatment:

Drug: Semaglutide