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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified February 2026 by Novo Nordisk A/S
Sponsor
Novo Nordisk A/S
Information Provided by (Responsible Party)
Novo Nordisk A/S
Clinicaltrials.gov Identifier
NCT06717698
Other Study ID Numbers:
NN9541-7841
First Submitted
November 29, 2024
First Posted
December 4, 2024
Last Update Posted
March 10, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Chronic Kidney Disease
Drug: NNC0519-0130Drug: PlaceboDrug: NNC0519-0130Drug: PlaceboDrug: NNC0519-0130Drug: PlaceboDrug: NNC0519-0130Drug: PlaceboDrug: Semaglutide

Study Design

Study TypeInterventional
Actual Enrollment465 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleEfficacy, Safety and Pharmacokinetics of NNC0519-0130 Once Weekly s.c. Versussemaglutide 1.0 mg and Placebo in People With Chronic Kidney Disease, With or Without Type 2 Diabetes, and With Overweight or Obesity: a Proof-of-concept and Dose-finding Study
Study Start DateDecember 1, 2024
Actual Primary Completion Date4mos 1w from now
Actual Study Completion Date4mos 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Dosing scheme a: 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.
Drug: NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Dosing scheme a: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Drug: Placebo
Placebo matching NNC0519-0130 will be administered subcutaneously.
Dosing scheme b: NNC0519-0130
Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Drug: NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Dosing scheme b: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Drug: Placebo
Placebo matching NNC0519-0130 will be administered subcutaneously.
Dosing scheme c: NNC0519-0130
Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Drug: NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Dosing scheme c: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Drug: Placebo
Placebo matching NNC0519-0130 will be administered subcutaneously.
Dosing scheme d: NNC0519-0130
Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Drug: NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Dosing scheme d: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Drug: Placebo
Placebo matching NNC0519-0130 will be administered subcutaneously.
Dosing scheme e: Semaglutide
Participants will receive once-weekly s.c injections of semaglutide with a dose escalation done until maintenance dose is reached.
Drug: Semaglutide
Semaglutide will be administered subcutaneously.

Outcome Measures

Primary Outcome Measures
  1. Change in urinary albumin-to-creatinine ratio (UACR) at week 12
    Measured as a ratio to baseline.
  2. Change in urinary albumin-to-creatinine ratio (UACR) at week 24
    Measured as a ratio to baseline.
  3. Change in urinary albumin-to-creatinine ratio (UACR) at week 36
    Measured as a ratio to baseline.
Secondary Outcome Measures
  1. Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021)
    Measured in mililitre per minute per 1.73 square metre (mL/min/1.73 m\^2).
  2. Change in estimated glomerular filtration rate (eGFR) (creatinine-based CKD-EPI 2021)
    Measured in mililitre per minute per 1.73 square metre (mL/min/1.73 m\^2).
  3. Relative change in body weight
    Measured in percentage (%).
  4. Achievement of greater than or equal to (≥) 5 percentage (%) weight reduction
    Measured as count of participants.
  5. Achievement of greater than or equal to (≥) 10 percentage (%) weight reduction
    Measured as count of participants.
  6. Change in waist circumference
    Measured in centimetres (cm).
  7. Change in glycated haemoglobin (HbA1c)
    Measured in percentage point (%-point).
  8. Change in systolic blood pressure
    Measured in millimetres of mercury (mmHg).
  9. Change in diastolic blood pressure
    Measured in millimetres of mercury (mmHg).
  10. Number of treatment emergent adverse events (TEAEs)
    Measured as count of events.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsNovo Nordisk A/S
Locations
N America Res Inst - San Dimas | San Dimas California, United States, 91773NorCal Endocrinology and Internal Medicine | San Ramon California, United States, 94583Rocky Mount Reg VA Med-DN | Aurora Colorado, United States, 80045Northeast Research Institute | Fleming Island Florida, United States, 32003Encore Medical Research LLC | Hollywood Florida, United States, 33024Northeast Research Institute | Saint Augustine Florida, United States, 32080Clinical Research of Cent FL | Winter Haven Florida, United States, 33880Endeavor Health | Skokie Illinois, United States, 60077Velocity Clin. Res Valparaiso | Valparaiso Indiana, United States, 46383Elite Research Center | Flint Michigan, United States, 48532Clinical Research Consultants | Kansas City Missouri, United States, 64111-5964Albany Medical College | Albany New York, United States, 12203Carteret Medical Group | Morehead City North Carolina, United States, 28557Brookview Hills Research Associates, LLC | Winston-Salem North Carolina, United States, 27103Davita Clinical Research | El Paso Texas, United States, 79902Clinical Advancement Center | San Antonio Texas, United States, 78212Tekton Research | San Antonio Texas, United States, 78251Providence Medical Research Center | Spokane Washington, United States, 99204Centro Médico CIMEL | Lanús Este Buenos Aires, Argentina, B1824KAJRenalida | Mar del Plata Buenos Aires, Argentina, B7600Centro de Investigaciones Metabólicas | City of Buenos Aires , Argentina, C1056ABIInstituto de Cardiología de Corrientes | Corrientes , Argentina, W3400AMYInstituto de Investigaciones Clinicas Mar Del Plata | Mar del Plata , Argentina, B7600FZNCastle Hill Medical Centre | Castle Hill New South Wales, Australia, 2154Gosford Renal Research | Gosford New South Wales, Australia, 2250Heart of Australia | Chelmer Queensland, Australia, 4068Melbourne Renal Research Group | Reservoir Victoria, Australia, 3073Sunshine Hospital - Western Centre for Health Research and Education | St Albans Victoria, Australia, 3021Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV | Curitiba Paraná, Brazil, 80045-110Instituto Pró-Renal Brasil | Curitiba Paraná, Brazil, 80440-020Centro de Diabetes Curitiba | Curitiba Paraná, Brazil, 80810-040Irmandade da Santa Casa de Misericórdia de Porto Alegre | Porto Alegre Rio Grande do Sul, Brazil, 90020-090Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda. | Porto Alegre Rio Grande do Sul, Brazil, 90430-001Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos | São Paulo , Brazil, 04038-002SRH - Zdrave EAD | Bankya , Bulgaria, 1320Medical centre Zdrave 1 OOD | Kozloduy , Bulgaria, 3320Nader Yabrudi - ASMPVBE Individual practice | Smolyan , Bulgaria, 4700Medical Centre Acad. Iv. Penchev EOOD | Sofia , Bulgaria, 1431Medical Centre Acad. Iv. Penchev EOOD | Sofia , Bulgaria, 1431USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology | Sofia , Bulgaria, 1431UMHAT Sofiamed EAD | Sofia , Bulgaria, 1750UMHAT Sveta Anna Sofia AD, Second Clinic of Internal Diseases | Sofia , Bulgaria, 1750UMHAT Sveta Marina EAD, Clinic of Internal Diseases | Varna , Bulgaria, 9010Nemocnice Český Krumlov, a.s. | Český Krumlov , Czechia, 381 01MUDr. Petr Buček s.r.o. | Frýdek-Místek , Czechia, 738 01CTC Hodonin s.r.o. | Hodonín , Czechia, 695 01FNKV-Internal Clinic-Nephrology | Prague , Czechia, 100 34DiaVize s.r.o. | Prague , Czechia, 140 00IKEM Klinika nefrologie | Prague , Czechia, 140 21Fledip s.r.o. | Prague , Czechia, 160 00Internist Care s.r.o. | Smiřice , Czechia, 503 03Endolife Specialty Hospitals | Guntur Andhra Pradesh, India, 522001MS Ramaiah | Bengaluru Karnataka, India, 560054Government Medical College, Kozhikode | Kozhikode Kerala, India, 673008SMS Medical College & Hospital | Jaipur Rajasthan, India, 302004Diabetes, Thyroid and Endocrine Centre | Jaipur Rajasthan, India, 302006Diabetes Research Center, Hyderabad | Hyderabad Telangana, India, 500082Nizams Institute of Medical Science | Hyderabad Telangana, India, 500082ASL Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UOC Diabetologia | L’Aquila Abbruzzo, Italy, 67100Università degli studi G. D'Annunzio Chieti Pescara - CAST | Chieti Abruzzo, Italy, 66100A.O.U. Bologna_ Policlinico S.Orsola Malpighi | Bologna BO, Italy, 40138Azienda Ospedaliera Papa Giovanni XXIII | Bergamo , Italy, 24127Azienda Ospedaliera Spedali Civili di Brescia | Brescia , Italy, 25121Azienda Ospedaliera Luigi Sacco | Milan , Italy, 20157Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello | Pisa , Italy, 56124Fondazione Policlinico Universitario Agostino Gemelli IRCS | Roma , Italy, 00168Seino Internal Medicine Clinic_Internal medicine | Koriyama-shi, Fukushima Fukushima, Japan, Japan, 963-8851TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology | Aichi , Japan, 468-0009Naka Kinen Clinic_Internal medicine | Ibaraki , Japan, 311-0113Naka Kinen Clinic_Internal medicine | Ibaraki , Japan, 311-0113Fujisawa City Hospital_Kidney internal medicine | Kanagawa , Japan, 251-8550Fujisawa City Hospital_Kidney internal medicine | Kanagawa , Japan, 251-8550Higashijujo Sakai Diabetes Clinic_Internal Medicine | Kita-ku, Tokyo , Japan, 114-0001Koshigaya Municipal Hospital_Internal medicine | Saitama , Japan, 343-8577Hanyu General Hospital_Internal Medicine | Saitama , Japan, 348-8505Shinden Higashi Clinic_Internal medicine | Sendai-shi, Miyagi , Japan, 983-0039Shinden Higashi Clinic | Sendai-shi, Miyagi , Japan, 983-0039Omihachiman Community Medical Center_Nephrology | Siga , Japan, 523-0082Omihachiman Community Medical Center_Nephrology | Siga , Japan, 523-0082Tokyo-Eki Center-building Clinic_Internal Medicine | Tokyo , Japan, 103-0027Fukuwa Clinic_Internal Medicine | Tokyo , Japan, 104-0031Fukuwa Clinic_Internal Medicine | Tokyo , Japan, 104-0031Fukuwa Clinic | Tokyo , Japan, 104-0031Kato Clinic of Internal Medicine_Internal Medicine | Tokyo , Japan, 125-0054Kato Clinic of Internal Medicine | Tokyo , Japan, 125-0054University Malaya Medical Centre | Kuala Lumpur Kuala Lumpur, Malaysia, 59100University Malaya Medical Centre | Lembah Pantai Kuala Lumpur, Malaysia, 59100Hospital Raja Permaisuri Bainun Ipoh | Ipoh Perak, Malaysia, 30450Hospital Pulau Pinang | George Town Pulau Pinang, Malaysia, 10990Hospital Miri | Miri Sarawak, Malaysia, 98000Hospital Sibu | Sibu Sarawak, Malaysia, 96000Hospital Sungai Buloh | Sungai Buloh Selangor, Malaysia, 47000Hospital Universiti Sains Malaysia | Kota Bharu, Kelantan , Malaysia, 16150Prince Court Medical Centre | Kuala Lumpur , Malaysia, 50450Hospital Melaka | Malacca , Malaysia, 75400Kardio Life - Tomasz Borkowski | Włocławek Kuyavian-Pomeranian Voivodeship, Poland, 87-800Terpa Sp. z o.o. Sp. k. | Lublin Lubelskie Voivodeship, Poland, 20-333Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie | Rzeszów Podkarpackie Voivodeship, Poland, 35-301Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok , Poland, 15-276Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok , Poland, 15-276Nowy Szpital Sp. z o.o. | Gmina Świecie , Poland, 86-100Nowy Szpital Sp. z o.o. | Gmina Świecie , Poland, 86-100Uniwersyteckie Centrum Kliniczne SUM w Katowicach | Katowice , Poland, 40-752SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego UM w Lodzi | Lodz , Poland, 90-153SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi | Lodz , Poland, 92-213Terpa Sp. z o.o. Sp. k. | Lublin , Poland, 20-333Zanamed Medical Clinic Sp. z o.o. | Lublin , Poland, 20-601Wojewodzki Szpital Specjalistyczny w Olsztynie | Olsztyn , Poland, 10-561Formed 2 Sp. z o.o. | Oświęcim , Poland, 32-600Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie | Szczecin , Poland, 70-111Szpitale Tczewskie S.A. | Tczew , Poland, 83-110PANSTWOWY INSTYTUT MEDYCZNY MSWiA | Warsaw , Poland, 02-507Centrum Medyczne Oporow | Wroclaw , Poland, 52-416Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko | Zabrze , Poland, 41-800National Health Insurance Corporation Ilsan Hospital | Goyang-si Gyeonggi-do, South Korea, 10444Pusan National University Hospital | Busan , South Korea, 49241Hallym UMC_Pyeongchon | Gyeonggi-do , South Korea, 14068Hanyang University GURI Hospital | Gyeonggi-do , South Korea, 471-101The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul , South Korea, 06591Korea University Guro Hospital | Seoul , South Korea, 08308Hospital Clinic i Provincial | Barcelona , Spain, 08036Hospital Reina Sofia | Córdoba , Spain, 14004Hospital Reina Sofia | Córdoba , Spain, 14004Hospital Universitario de Getafe | Getafe , Spain, 28905Hospital de Bellvitge | L'Hospitalet de Llobregat , Spain, 08907Hospital de Bellvitge | L'Hospitalet de Llobregat , Spain, 08907Fundacion Jiménez Díaz | Madrid , Spain, 28040Fundacion Jiménez Díaz | Madrid , Spain, 28040Hospital Clínico San Carlos | Madrid , Spain, 28040Clínica Nuevas Tecnologías en Diabetes y Endocrinología | Seville , Spain, 41003Clínica Nuevas Tecnologías en Diabetes y Endocrinología | Seville , Spain, 41003Hospital Universitario Doctor Peset | Valencia , Spain, 46017Hospital Universitario Doctor Peset | Valencia , Spain, 46017Erciyes Üniversitesi Hastanesi - Nefroloji | Kayseri Melikgazi, Turkey (Türkiye), 38039Adana Şehir Eğitim ve Araştırma Hastanesi | Adana , Turkey (Türkiye), 01060Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali | Ankara , Turkey (Türkiye), 06230Hacettepe Üniversitesi Hastanesi- Nefroloji | Ankara , Turkey (Türkiye), 06230Ankara Bilkent Şehir Hastanesi-Dahiliye | Ankara , Turkey (Türkiye), 06800Ankara Sehir Hastanesi Dahiliye Klinigi | Ankara , Turkey (Türkiye), 06800Gaziantep Universitesi Tip Fakultesi Hastanesi | Gaziantep , Turkey (Türkiye), 27070Gaziantep Üniversitesi Hastanesi- Endokrinoloji | Gaziantep , Turkey (Türkiye), 27070Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye | Istanbul , Turkey (Türkiye), 34722T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital | Istanbul , Turkey (Türkiye), 34722Ege Universitesi Hastanesi- Endokrinoloji | Izmir , Turkey (Türkiye), 35100Ege Universitesi Tip Fakultesi Hastanesi | Izmir , Turkey (Türkiye), 35100Kocaeli University Nephrology Department | Kocaeli , Turkey (Türkiye), 41380Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji | Kocaeli , Turkey (Türkiye), 41380
Investigators
Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S