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Recruiting Phase 2 NCT06717698

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

Phase 2 – studying effectiveness and dosage
Conditions: Chronic Kidney Disease

Sponsor: Novo Nordisk A/S

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 14
Argentina (1)
Centro Médico CIMEL
Lanús Este , Buenos Aires
ACTIVE_NOT_RECRUITING
Australia (1)
Castle Hill Medical Centre
Castle Hill , New South Wales
ACTIVE_NOT_RECRUITING
Brazil (1)
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
Curitiba , Paraná
ACTIVE_NOT_RECRUITING
Bulgaria (1)
SRH - Zdrave EAD
Bankya
ACTIVE_NOT_RECRUITING
Czech Republic (1)
Nemocnice Český Krumlov, a.s.
Český Krumlov
WITHDRAWN
India (1)
Endolife Specialty Hospitals
Guntur , Andhra Pradesh
NOT_YET_RECRUITING
Italy (1)
ASL Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UOC Diabetologia
L’Aquila , Abbruzzo
ACTIVE_NOT_RECRUITING
Japan (1)
Seino Internal Medicine Clinic_Internal medicine
Koriyama-shi, Fukushima , Fukushima, Japan
ACTIVE_NOT_RECRUITING
Malaysia (1)
University Malaya Medical Centre
Kuala Lumpur , Kuala Lumpur
Poland (1)
Kardio Life - Tomasz Borkowski
Włocławek , Kuyavian-Pomeranian Voivodeship
ACTIVE_NOT_RECRUITING
South Korea (1)
National Health Insurance Corporation Ilsan Hospital
Goyang-si , Gyeonggi-do
COMPLETED
Spain (1)
Hospital Clinic i Provincial
Barcelona
ACTIVE_NOT_RECRUITING
Turkey (1)
Erciyes Üniversitesi Hastanesi - Nefroloji
Kayseri , Melikgazi
ACTIVE_NOT_RECRUITING
United States (1)
N America Res Inst - San Dimas
San Dimas , California
ACTIVE_NOT_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
02.12.2024
Completion date
17.09.2026
Registry ID
NCT06717698
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.