A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease
Efficacy, 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
3 other identifiers
interventional
465
14 countries
147
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2024
147 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2024
CompletedStudy Start
First participant enrolled
December 2, 2024
CompletedFirst Posted
Study publicly available on registry
December 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 17, 2026
March 11, 2026
March 1, 2026
1.7 years
November 30, 2024
March 10, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Change in urinary albumin-to-creatinine ratio (UACR) at week 12
Measured as a ratio to baseline.
From baseline (week 0) to end of a given maintenance dose period (week 12)
Change in urinary albumin-to-creatinine ratio (UACR) at week 24
Measured as a ratio to baseline.
From baseline (week 0) to end of a given maintenance dose period (week 24)
Change in urinary albumin-to-creatinine ratio (UACR) at week 36
Measured as a ratio to baseline.
From baseline (week 0) to end of a given maintenance dose period (week 36)
Secondary Outcomes (10)
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)
Change in estimated glomerular filtration rate (eGFR) (creatinine-based CKD-EPI 2021)
From baseline (week 0) to end of treatment (week 36)
Relative change in body weight
From baseline (week 0) to end of treatment (week 36)
Achievement of greater than or equal to (≥) 5 percentage (%) weight reduction
From baseline (week 0) to end of treatment (week 36)
Achievement of greater than or equal to (≥) 10 percentage (%) weight reduction
From baseline (week 0) to end of treatment (week 36)
- +5 more secondary outcomes
Study Arms (9)
Dosing scheme a: NNC0519-0130
EXPERIMENTALParticipants 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 COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Dosing scheme b: NNC0519-0130
EXPERIMENTALParticipants 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 COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Dosing scheme c: NNC0519-0130
EXPERIMENTALParticipants 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 COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Dosing scheme d: NNC0519-0130
EXPERIMENTALParticipants 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 COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Dosing scheme e: Semaglutide
ACTIVE COMPARATORParticipants will receive once-weekly s.c injections of semaglutide with a dose escalation done until maintenance dose is reached.
Interventions
Placebo matching NNC0519-0130 will be administered subcutaneously.
NNC0519-0130 will be administered subcutaneously.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (147)
N America Res Inst - San Dimas
San Dimas, California, 91773, United States
NorCal Endocrinology and Internal Medicine
San Ramon, California, 94583, United States
Rocky Mount Reg VA Med-DN
Aurora, Colorado, 80045, United States
Northeast Research Institute
Fleming Island, Florida, 32003, United States
Encore Medical Research LLC
Hollywood, Florida, 33024, United States
Northeast Research Institute
Saint Augustine, Florida, 32080, United States
Clinical Research of Cent FL
Winter Haven, Florida, 33880, United States
Endeavor Health
Skokie, Illinois, 60077, United States
Velocity Clin. Res Valparaiso
Valparaiso, Indiana, 46383, United States
Elite Research Center
Flint, Michigan, 48532, United States
Clinical Research Consultants
Kansas City, Missouri, 64111-5964, United States
Albany Medical College
Albany, New York, 12203, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, 27103, United States
Davita Clinical Research
El Paso, Texas, 79902, United States
Clinical Advancement Center
San Antonio, Texas, 78212, United States
Tekton Research
San Antonio, Texas, 78251, United States
Providence Medical Research Center
Spokane, Washington, 99204, United States
Centro Médico CIMEL
Lanús Este, Buenos Aires, B1824KAJ, Argentina
Renalida
Mar del Plata, Buenos Aires, B7600, Argentina
Centro de Investigaciones Metabólicas
City of Buenos Aires, C1056ABI, Argentina
Instituto de Cardiología de Corrientes
Corrientes, W3400AMY, Argentina
Instituto de Investigaciones Clinicas Mar Del Plata
Mar del Plata, B7600FZN, Argentina
Castle Hill Medical Centre
Castle Hill, New South Wales, 2154, Australia
Gosford Renal Research
Gosford, New South Wales, 2250, Australia
Heart of Australia
Chelmer, Queensland, 4068, Australia
Melbourne Renal Research Group
Reservoir, Victoria, 3073, Australia
Sunshine Hospital - Western Centre for Health Research and Education
St Albans, Victoria, 3021, Australia
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
Curitiba, Paraná, 80045-110, Brazil
Instituto Pró-Renal Brasil
Curitiba, Paraná, 80440-020, Brazil
Centro de Diabetes Curitiba
Curitiba, Paraná, 80810-040, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos
São Paulo, 04038-002, Brazil
SRH - Zdrave EAD
Bankya, 1320, Bulgaria
Medical centre Zdrave 1 OOD
Kozloduy, 3320, Bulgaria
Nader Yabrudi - ASMPVBE Individual practice
Smolyan, 4700, Bulgaria
Medical Centre Acad. Iv. Penchev EOOD
Sofia, 1431, Bulgaria
Medical Centre Acad. Iv. Penchev EOOD
Sofia, 1431, Bulgaria
USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology
Sofia, 1431, Bulgaria
UMHAT Sofiamed EAD
Sofia, 1750, Bulgaria
UMHAT Sveta Anna Sofia AD, Second Clinic of Internal Diseases
Sofia, 1750, Bulgaria
UMHAT Sveta Marina EAD, Clinic of Internal Diseases
Varna, 9010, Bulgaria
Nemocnice Český Krumlov, a.s.
Český Krumlov, 381 01, Czechia
MUDr. Petr Buček s.r.o.
Frýdek-Místek, 738 01, Czechia
CTC Hodonin s.r.o.
Hodonín, 695 01, Czechia
FNKV-Internal Clinic-Nephrology
Prague, 100 34, Czechia
DiaVize s.r.o.
Prague, 140 00, Czechia
IKEM Klinika nefrologie
Prague, 140 21, Czechia
Fledip s.r.o.
Prague, 160 00, Czechia
Internist Care s.r.o.
Smiřice, 503 03, Czechia
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, 522001, India
MS Ramaiah
Bengaluru, Karnataka, 560054, India
Government Medical College, Kozhikode
Kozhikode, Kerala, 673008, India
SMS Medical College & Hospital
Jaipur, Rajasthan, 302004, India
Diabetes, Thyroid and Endocrine Centre
Jaipur, Rajasthan, 302006, India
Diabetes Research Center, Hyderabad
Hyderabad, Telangana, 500082, India
Nizams Institute of Medical Science
Hyderabad, Telangana, 500082, India
ASL Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UOC Diabetologia
L’Aquila, Abbruzzo, 67100, Italy
Università degli studi G. D'Annunzio Chieti Pescara - CAST
Chieti, Abruzzo, 66100, Italy
A.O.U. Bologna_ Policlinico S.Orsola Malpighi
Bologna, BO, 40138, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25121, Italy
Azienda Ospedaliera Luigi Sacco
Milan, 20157, Italy
Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello
Pisa, 56124, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCS
Roma, 00168, Italy
Seino Internal Medicine Clinic_Internal medicine
Koriyama-shi, Fukushima, Fukushima, Japan, 963-8851, Japan
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
Aichi, 468-0009, Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113, Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113, Japan
Fujisawa City Hospital_Kidney internal medicine
Kanagawa, 251-8550, Japan
Fujisawa City Hospital_Kidney internal medicine
Kanagawa, 251-8550, Japan
Higashijujo Sakai Diabetes Clinic_Internal Medicine
Kita-ku, Tokyo, 114-0001, Japan
Koshigaya Municipal Hospital_Internal medicine
Saitama, 343-8577, Japan
Hanyu General Hospital_Internal Medicine
Saitama, 348-8505, Japan
Shinden Higashi Clinic_Internal medicine
Sendai-shi, Miyagi, 983-0039, Japan
Shinden Higashi Clinic
Sendai-shi, Miyagi, 983-0039, Japan
Omihachiman Community Medical Center_Nephrology
Siga, 523-0082, Japan
Omihachiman Community Medical Center_Nephrology
Siga, 523-0082, Japan
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, 103-0027, Japan
Fukuwa Clinic_Internal Medicine
Tokyo, 104-0031, Japan
Fukuwa Clinic_Internal Medicine
Tokyo, 104-0031, Japan
Fukuwa Clinic
Tokyo, 104-0031, Japan
Kato Clinic of Internal Medicine_Internal Medicine
Tokyo, 125-0054, Japan
Kato Clinic of Internal Medicine
Tokyo, 125-0054, Japan
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
Hospital Raja Permaisuri Bainun Ipoh
Ipoh, Perak, 30450, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, 10990, Malaysia
Hospital Miri
Miri, Sarawak, 98000, Malaysia
Hospital Sibu
Sibu, Sarawak, 96000, Malaysia
Hospital Sungai Buloh
Sungai Buloh, Selangor, 47000, Malaysia
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150, Malaysia
Prince Court Medical Centre
Kuala Lumpur, 50450, Malaysia
Hospital Melaka
Malacca, 75400, Malaysia
Kardio Life - Tomasz Borkowski
Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800, Poland
Terpa Sp. z o.o. Sp. k.
Lublin, Lubelskie Voivodeship, 20-333, Poland
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
Rzeszów, Podkarpackie Voivodeship, 35-301, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276, Poland
Nowy Szpital Sp. z o.o.
Gmina Świecie, 86-100, Poland
Nowy Szpital Sp. z o.o.
Gmina Świecie, 86-100, Poland
Uniwersyteckie Centrum Kliniczne SUM w Katowicach
Katowice, 40-752, Poland
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego UM w Lodzi
Lodz, 90-153, Poland
SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz, 92-213, Poland
Terpa Sp. z o.o. Sp. k.
Lublin, 20-333, Poland
Zanamed Medical Clinic Sp. z o.o.
Lublin, 20-601, Poland
Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn, 10-561, Poland
Formed 2 Sp. z o.o.
Oświęcim, 32-600, Poland
Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie
Szczecin, 70-111, Poland
Szpitale Tczewskie S.A.
Tczew, 83-110, Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, 02-507, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
Zabrze, 41-800, Poland
National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do, 10444, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Hallym UMC_Pyeongchon
Gyeonggi-do, 14068, South Korea
Hanyang University GURI Hospital
Gyeonggi-do, 471-101, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, 06591, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Hospital Clinic i Provincial
Barcelona, 08036, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario de Getafe
Getafe, 28905, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Fundacion Jiménez Díaz
Madrid, 28040, Spain
Fundacion Jiménez Díaz
Madrid, 28040, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Seville, 41003, Spain
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Seville, 41003, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Erciyes Üniversitesi Hastanesi - Nefroloji
Kayseri, Melikgazi, 38039, Turkey (Türkiye)
Adana Şehir Eğitim ve Araştırma Hastanesi
Adana, 01060, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali
Ankara, 06230, Turkey (Türkiye)
Hacettepe Üniversitesi Hastanesi- Nefroloji
Ankara, 06230, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Dahiliye
Ankara, 06800, Turkey (Türkiye)
Ankara Sehir Hastanesi Dahiliye Klinigi
Ankara, 06800, Turkey (Türkiye)
Gaziantep Universitesi Tip Fakultesi Hastanesi
Gaziantep, 27070, Turkey (Türkiye)
Gaziantep Üniversitesi Hastanesi- Endokrinoloji
Gaziantep, 27070, Turkey (Türkiye)
Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
Istanbul, 34722, Turkey (Türkiye)
T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, 34722, Turkey (Türkiye)
Ege Universitesi Hastanesi- Endokrinoloji
Izmir, 35100, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
Kocaeli University Nephrology Department
Kocaeli, 41380, Turkey (Türkiye)
Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji
Kocaeli, 41380, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2024
First Posted
December 5, 2024
Study Start
December 2, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 17, 2026
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com