A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease
- Conditions
- Interventions
- Registration Number
- NCT06717698
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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 do...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 465
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dosing scheme e: Semaglutide Semaglutide Participants will receive once-weekly s.c injections of semaglutide with a dose escalation done until maintenance dose is reached. Dosing scheme a: NNC0519-0130 NNC0519-0130 Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached. Dosing scheme a: Placebo Placebo Participants will receive NNC0519-0130 matched placebo s.c. once-weekly. Dosing scheme b: NNC0519-0130 NNC0519-0130 Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached. Dosing scheme b: Placebo Placebo Participants will receive NNC0519-0130 matched placebo s.c. once-weekly. Dosing scheme c: NNC0519-0130 NNC0519-0130 Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached. Dosing scheme c: Placebo Placebo Participants will receive NNC0519-0130 matched placebo s.c. once-weekly. Dosing scheme d: NNC0519-0130 NNC0519-0130 Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached. Dosing scheme d: Placebo Placebo Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
- Primary Outcome Measures
Name Time Method Change in urinary albumin-to-creatinine ratio (UACR) at week 12 From 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 24 From 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 36 From baseline (week 0) to end of a given maintenance dose period (week 36) Measured as a ratio to baseline.
- Secondary Outcome Measures
Name Time Method Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021) From baseline (week 0) to end of treatment (week 36) Measured in mililitre per minute per 1.73 square metre (mL/min/1.73 m\^2).
Change in estimated glomerular filtration rate (eGFR) (creatinine-based CKD-EPI 2021) From baseline (week 0) to end of treatment (week 36) Measured in mililitre per minute per 1.73 square metre (mL/min/1.73 m\^2).
Relative change in body weight From baseline (week 0) to end of treatment (week 36) Measured in percentage (%).
Achievement of greater than or equal to (≥) 5 percentage (%) weight reduction From baseline (week 0) to end of treatment (week 36) Measured as count of participants.
Achievement of greater than or equal to (≥) 10 percentage (%) weight reduction From baseline (week 0) to end of treatment (week 36) Measured as count of participants.
Change in waist circumference From baseline (week 0) to end of treatment (week 36) Measured in centimetres (cm).
Change in glycated haemoglobin (HbA1c) From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36) Measured in percentage point (%-point).
Change in systolic blood pressure From baseline (week 0) to end of treatment (week 36) Measured in millimetres of mercury (mmHg).
Change in diastolic blood pressure From baseline (week 0) to end of treatment (week 36) Measured in millimetres of mercury (mmHg).
Number of treatment emergent adverse events (TEAEs) From baseline (week 0) to end of study (week 40) Measured as count of events.
Trial Locations
- Locations (99)
N America Res Inst - San Dimas
🇺🇸San Dimas, California, United States
NorCal Endocrinology and Internal Medicine
🇺🇸San Ramon, California, United States
Northeast Research Institute
🇺🇸Saint Augustine, Florida, United States
Encore Medical Research LLC
🇺🇸Hollywood, 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
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
Clinical Advancement Ctr, PLLC
🇺🇸San Antonio, Texas, United States
Providence Medical Research Center
🇺🇸Spokane, Washington, United States
Centro Médico CIMEL
🇦🇷Lanus Este, Buenos Aires, Argentina
Centro de Investigaciones Metabólicas
🇦🇷City of Buenos Aires, Argentina
Instituto de Cardiología de Corrientes
🇦🇷Corrientes, Argentina
Instituto de Investigaciones Clinicas
🇦🇷Mar del Plata, Argentina
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
🇧🇷Curitiba, Parana, Brazil
Instituto Pró-Renal Brasil
🇧🇷Curitiba, Parana, Brazil
Centro de Diabetes Curitiba
🇧🇷Curitiba, Parana, 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
🇧🇷Sao Paulo, Brazil
Specialized Rehabilitation Hospital Zdrave EAD
🇧🇬Bankya, Bulgaria
"Medical Centre Acad. Iv. Penchev" EOOD
🇧🇬Sofia, Bulgaria
USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
🇧🇬Sofia, Bulgaria
"UMHAT "Sveta Anna" Sofia"
🇧🇬Sofia, Bulgaria
UMHAT Sofiamed
🇧🇬Sofia, Bulgaria
UMHAT Sveta Marina EAD
🇧🇬Varna, Bulgaria
MUDr. Petr Buček s.r.o.
🇨🇿Frýdek Místek, Czechia
CTC Hodonin s.r.o.
🇨🇿Hodonin, Czechia
FNKV-Internal Clinic-Nephrology
🇨🇿Praha 10, Czechia
DiaVize s.r.o.
🇨🇿Praha, Czechia
IKEM Klinika nefrologie
🇨🇿Praha 4, Czechia
Fledip s.r.o.
🇨🇿Praha 6, Czechia
Internist Care s.r.o.
🇨🇿Smiřice, Czechia
Nemocnice Český Krumlov, a.s.
🇨🇿Český Krumlov, Czechia
Endolife Specialty Hospitals
🇮🇳Guntur, Andhra Pradesh, India
MS Ramaiah
🇮🇳Bengaluru, Karnataka, India
Government Medical College, Kozhikode
🇮🇳Kozhikode, Kerala, India
SMS Medical College & Hospital
🇮🇳Jaipur, Rajasthan, India
Diabetes, Thyroid and Endocrine Centre
🇮🇳Jaipur, Rajasthan, India
Diabetes Research Center, Hyderabad
🇮🇳Hyderabad, Telangana, India
Nizams Institute of Medical Science
🇮🇳Hyderabad, Telangana, India
Ospedale San Salvatore, Dipartimento Medico ASL1 Abruzzo, UOC Diabetologia
🇮🇹L'Aquila, Abbruzzo, Italy
A.O.U. Policlinico S.Orsola Malpighi
🇮🇹Bologna, BO, Italy
Azienda Ospedaliera Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Azienda Ospedaliera Spedali Civili di Brescia
🇮🇹Brescia, Italy
Università degli studi G. D'Annunzio Chieti Pescara - CAST
🇮🇹Chieti Scalo, Italy
Azienda Ospedaliera Luigi Sacco
🇮🇹Milano, Italy
Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello
🇮🇹Pisa, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Roma, Italy
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
🇯🇵Aichi, Japan
Naka Kinen Clinic
🇯🇵Ibaraki, Japan
Fujisawa City Hospital_Kidney internal medicine
🇯🇵Kanagawa, Japan
Higashijujo Sakai Diabetes Clinic_Internal Medicine
🇯🇵Kita-ku, Tokyo, Japan
Koshigaya Municipal Hospital_Internal medicine
🇯🇵Saitama, Japan
Hanyu General Hospital_Internal Medicine
🇯🇵Saitama, Japan
Shinden Higashi Clinic
🇯🇵Sendai-shi, Miyagi, Japan
Omihachiman Community Medical Center_Nephrology
🇯🇵Siga, Japan
Kato Clinic of Internal Medicine
🇯🇵Tokyo, Japan
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
🇰🇷Goyang, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Gyeonggi-Do, Korea, Republic of
Hanyang University GURI Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Seoul Saint Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Raja Permaisuri Bainun Ipoh
🇲🇾Ipoh, Perak, Malaysia
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Hospital Universiti Sains Malaysia
🇲🇾Kota Bharu, Kelantan, Malaysia
Prince Court Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Hospital Melaka
🇲🇾Melaka, Malaysia
Hospital Pulau Pinang
🇲🇾Pulau Pinang, Malaysia
Hospital Sungai Buloh
🇲🇾Sungai Buloh, Malaysia
Terpa Sp. z o.o. Sp. k.
🇵🇱Lublin, Lubelskie Voivodeship, Poland
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
🇵🇱Rzeszow, Podkarpackie, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Białystok, Poland
Uniwersyteckie Centrum Kliniczne SUM w Katowicach
🇵🇱Katowice, Poland
Zanamed Medical Clinic Sp. z o.o.
🇵🇱Lublin, Poland
Wojewodzki Szpital Specjalistyczny w Olsztynie
🇵🇱Olsztyn, Poland
Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie
🇵🇱Szczecin, Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
🇵🇱Warszawa, Poland
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
SP ZOZ Centralny Szpital Kliniczny Uniwerystetu Medycznego w Łodzi
🇵🇱Łódź, Poland
Nowy Szpital Sp. z o.o.
🇵🇱Świecie, Poland
Hospital Reina Sofia
🇪🇸Córdoba, Spain
Hospital de Bellvitge
🇪🇸Hospitalet de Llobregat, Spain
Fundacion Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
🇪🇸Sevilla, Spain
Hospital Universitario Doctor Peset
🇪🇸Valencia, Spain
Erciyes Universitesi Tip Fakultesi
🇹🇷Kayseri, Melikgazi, Turkey
Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali
🇹🇷Ankara, Turkey
Ankara Sehir Hastanesi Dahiliye Klinigi
🇹🇷Ankara, Turkey
T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
🇹🇷Adana, Turkey
Gaziantep Universitesi Tip Fakultesi Hastanesi
🇹🇷Gaziantep, Turkey
T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital
🇹🇷Istanbul, Turkey
Ege Universitesi Tip Fakultesi Hastanesi
🇹🇷Izmir, Turkey
Kocaeli University Nephrology Department
🇹🇷Kocaeli, Turkey