Clinical trial

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

Recruiting now · Phase 2 · 6 countries · Registry ID NCT06717698

Recruiting nowPhase 2Interventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionChronic Kidney Disease

Full registry criteria

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 screening. * 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 diabetic 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.

Treatments and study arms

NNC0519-0130

Drug

NNC0519-0130 will be administered subcutaneously.

Placebo

Drug

Placebo matching NNC0519-0130 will be administered subcutaneously.

Semaglutide

Drug

Semaglutide will be administered subcutaneously.

Primary outcomes

Change in urinary albumin-to-creatinine ratio (UACR) at week 12From baseline (week 0) to end of a given maintenance dose period (week 12)

Measured as a ratio to baseline.

Change in urinary albumin-to-creatinine ratio (UACR) at week 24From baseline (week 0) to end of a given maintenance dose period (week 24)

Measured as a ratio to baseline.

Change in urinary albumin-to-creatinine ratio (UACR) at week 36From baseline (week 0) to end of a given maintenance dose period (week 36)

Measured as a ratio to baseline.

Study locations

147 locations were listed when this page was built. The first 40 are shown.

Centro de Investigaciones Metabólicas🇦🇷 City of Buenos Aires, Argentina
Instituto de Cardiología de Corrientes🇦🇷 Corrientes, Argentina
Centro Médico CIMEL🇦🇷 Lanús Este, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar Del Plata🇦🇷 Mar del Plata, Argentina
Renalida🇦🇷 Mar del Plata, Buenos Aires, Argentina
Castle Hill Medical Centre🇦🇺 Castle Hill, New South Wales, Australia
Heart of Australia🇦🇺 Chelmer, Queensland, Australia
Gosford Renal Research🇦🇺 Gosford, New South Wales, Australia
Melbourne Renal Research Group🇦🇺 Reservoir, Victoria, Australia
Sunshine Hospital - Western Centre for Health Research and Education🇦🇺 St Albans, Victoria, Australia
Centro de Diabetes Curitiba🇧🇷 Curitiba, Paraná, Brazil
Instituto Pró-Renal Brasil🇧🇷 Curitiba, Paraná, Brazil
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV🇧🇷 Curitiba, Paraná, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil
Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos🇧🇷 São Paulo, Brazil
SRH - Zdrave EAD🌐 Bankya, Bulgaria
Medical centre Zdrave 1 OOD🌐 Kozloduy, Bulgaria
Nader Yabrudi - ASMPVBE Individual practice🌐 Smolyan, Bulgaria
Medical Centre Acad. Iv. Penchev EOOD🌐 Sofia, Bulgaria
Medical Centre Acad. Iv. Penchev EOOD🌐 Sofia, Bulgaria
UMHAT Sofiamed EAD🌐 Sofia, Bulgaria
UMHAT Sveta Anna Sofia AD, Second Clinic of Internal Diseases🌐 Sofia, Bulgaria
USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology🌐 Sofia, Bulgaria
UMHAT Sveta Marina EAD, Clinic of Internal Diseases🌐 Varna, Bulgaria
MUDr. Petr Buček s.r.o.🇨🇿 Frýdek-Místek, Czechia
CTC Hodonin s.r.o.🇨🇿 Hodonín, Czechia
DiaVize s.r.o.🇨🇿 Prague, Czechia
FNKV-Internal Clinic-Nephrology🇨🇿 Prague, Czechia
Fledip s.r.o.🇨🇿 Prague, Czechia
IKEM Klinika nefrologie🇨🇿 Prague, Czechia
Internist Care s.r.o.🇨🇿 Smiřice, Czechia
Nemocnice Český Krumlov, a.s.🇨🇿 Český Krumlov, Czechia
MS Ramaiah🇮🇳 Bengaluru, Karnataka, India
Endolife Specialty Hospitals🇮🇳 Guntur, Andhra Pradesh, India
Diabetes Research Center, Hyderabad🇮🇳 Hyderabad, Telangana, India
Nizams Institute of Medical Science🇮🇳 Hyderabad, Telangana, India
Diabetes, Thyroid and Endocrine Centre🇮🇳 Jaipur, Rajasthan, India
SMS Medical College & Hospital🇮🇳 Jaipur, Rajasthan, India
Government Medical College, Kozhikode🇮🇳 Kozhikode, Kerala, India