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 · NCT06717698 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 11 US states.
- N America Res Inst - San Dimas - San Dimas, California, United States
- NorCal Endocrinology and Internal Medicine - San Ramon, California, United States
- Rocky Mount Reg VA Med-DN - Aurora, Colorado, United States
- Northeast Research Institute - Fleming Island, Florida, United States
- Encore Medical Research LLC - Hollywood, Florida, United States
- Northeast Research Institute - Saint Augustine, Florida, United States
- Clinical Research of Cent FL - Winter Haven, Florida, United States
- Endeavor Health - Skokie, Illinois, United States
- Velocity Clin. Res Valparaiso - Valparaiso, Indiana, United States
- Elite Research Center - Flint, Michigan, United States
- Clinical Research Consultants - Kansas City, Missouri, United States
- Albany Medical College - Albany, New York, United States
- Carteret Medical Group - Morehead City, North Carolina, United States
- Brookview Hills Research Associates, LLC - Winston-Salem, North Carolina, United States
- Davita Clinical Research - El Paso, Texas, United States
- Clinical Advancement Center - San Antonio, Texas, United States
- Tekton Research - San Antonio, Texas, United States
- Providence Medical Research Center - Spokane, Washington, United States
- Adana Şehir Eğitim ve Araştırma Hastanesi - Adana, Turkey (Türkiye)
- TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology - Aichi, Japan
- Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali - Ankara, Turkey (Türkiye)
- Hacettepe Üniversitesi Hastanesi- Nefroloji - Ankara, Turkey (Türkiye)
- Ankara Bilkent Şehir Hastanesi-Dahiliye - Ankara, Turkey (Türkiye)
- Ankara Sehir Hastanesi Dahiliye Klinigi - Ankara, Turkey (Türkiye)
- SRH - Zdrave EAD - Bankya, Bulgaria
- Hospital Clinic i Provincial - Barcelona, Spain
- Azienda Ospedaliera Papa Giovanni XXIII - Bergamo, Italy
- Uniwersytecki Szpital Kliniczny w Bialymstoku - Bialystok, Poland
- Uniwersytecki Szpital Kliniczny w Bialymstoku - Bialystok, Poland
- Azienda Ospedaliera Spedali Civili di Brescia - Brescia, Italy
- Pusan National University Hospital - Busan, South Korea
- Centro de Investigaciones Metabólicas - City of Buenos Aires, Argentina
- Instituto de Cardiología de Corrientes - Corrientes, Argentina
- Hospital Reina Sofia - Córdoba, Spain
- Hospital Reina Sofia - Córdoba, Spain
- MUDr. Petr Buček s.r.o. - Frýdek-Místek, Czechia
- Gaziantep Universitesi Tip Fakultesi Hastanesi - Gaziantep, Turkey (Türkiye)
- Gaziantep Üniversitesi Hastanesi- Endokrinoloji - Gaziantep, Turkey (Türkiye)
- Hospital Universitario de Getafe - Getafe, Spain
- Nowy Szpital Sp. z o.o. - Gmina Świecie, Poland
- Nowy Szpital Sp. z o.o. - Gmina Świecie, Poland
- Hallym UMC_Pyeongchon - Gyeonggi-do, South Korea
- Hanyang University GURI Hospital - Gyeonggi-do, South Korea
- CTC Hodonin s.r.o. - Hodonín, Czechia
- Naka Kinen Clinic_Internal medicine - Ibaraki, Japan
- Naka Kinen Clinic_Internal medicine - Ibaraki, Japan
- Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye - Istanbul, Turkey (Türkiye)
- T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Istanbul, Turkey (Türkiye)
- Ege Universitesi Hastanesi- Endokrinoloji - Izmir, Turkey (Türkiye)
- Ege Universitesi Tip Fakultesi Hastanesi - Izmir, Turkey (Türkiye)
- Fujisawa City Hospital_Kidney internal medicine - Kanagawa, Japan
- Fujisawa City Hospital_Kidney internal medicine - Kanagawa, Japan
- Uniwersyteckie Centrum Kliniczne SUM w Katowicach - Katowice, Poland
- Higashijujo Sakai Diabetes Clinic_Internal Medicine - Kita-ku, Tokyo, Japan
- Kocaeli University Nephrology Department - Kocaeli, Turkey (Türkiye)
- Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji - Kocaeli, Turkey (Türkiye)
- Hospital Universiti Sains Malaysia - Kota Bharu, Kelantan, Malaysia
- Medical centre Zdrave 1 OOD - Kozloduy, Bulgaria
- Prince Court Medical Centre - Kuala Lumpur, Malaysia
- Hospital de Bellvitge - L'Hospitalet de Llobregat, Spain
Showing 60 of 147 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →