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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Semaglutide; Drug: NNC0519-0130; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 465
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Argentina
  • City of Buenos Aires, Argentina, C1056ABI
    • Active, not recruiting
    • Centro de Investigaciones Metabólicas
  • Corrientes, Argentina, W3400AMY
    • Active, not recruiting
    • Instituto de Cardiologia de Corrientes
  • Mar del Plata, Argentina, B7600FZN
    • Active, not recruiting
    • Instituto de Investigaciones Clinicas Mar del Plata
  • Buenos Aires
    • Lanús Este, Buenos Aires, Argentina, B1824KAJ
      • Active, not recruiting
      • Centro Médico CIMEL
    • Mar del Plata, Buenos Aires, Argentina, B7600
      • Active, not recruiting
      • Renalida
• Australia
  • New South Wales
    • Castle Hill, New South Wales, Australia, 2154
      • Active, not recruiting
      • Castle Hill Medical Centre
    • Gosford, New South Wales, Australia, 2250
      • Active, not recruiting
      • Gosford Renal Research
  • Queensland
    • Chelmer, Queensland, Australia, 4068
      • Active, not recruiting
      • Heart of Australia
  • Victoria
    • Reservoir, Victoria, Australia, 3073
      • Not yet recruiting
      • Melbourne Renal Research Group
    • St Albans, Victoria, Australia, 3021
      • Active, not recruiting
      • Sunshine Hospital - Western Centre for Health Research and Education
• Brazil
  • São Paulo, Brazil, 04038-002
    • Active, not recruiting
    • Hospital Do Rim E Hipertensao Fundacao Oswaldo Ramos
  • Paraná
    • Curitiba, Paraná, Brazil, 80045-110
      • Active, not recruiting
      • Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
    • Curitiba, Paraná, Brazil, 80440-020
      • Active, not recruiting
      • Instituto Pró-Renal Brasil
    • Curitiba, Paraná, Brazil, 80810-040
      • Active, not recruiting
      • Centro de Diabetes Curitiba
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
      • Active, not recruiting
      • Irmandade Da Santa Casa de Misericórdia de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
      • Active, not recruiting
      • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
• Bulgaria
  • Bankya, Bulgaria, 1320
    • Active, not recruiting
    • SRH - Zdrave EAD
  • Kozloduy, Bulgaria, 3320
    • Active, not recruiting
    • Medical centre Zdrave 1 OOD
  • Smolyan, Bulgaria, 4700
    • Active, not recruiting
    • Nader Yabrudi - ASMPVBE Individual practice
  • Sofia, Bulgaria, 1431
    • Completed
    • Medical Centre Acad. Iv. Penchev EOOD
  • Sofia, Bulgaria, 1431
    • Active, not recruiting
    • Medical Centre Acad. Iv. Penchev EOOD
  • Sofia, Bulgaria, 1431
    • Active, not recruiting
    • USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology
  • Sofia, Bulgaria, 1750
    • Active, not recruiting
    • UMHAT Sofiamed EAD
  • Sofia, Bulgaria, 1750
    • Active, not recruiting
    • UMHAT Sveta Anna Sofia AD, Second Clinic of Internal Diseases
  • Varna, Bulgaria, 9010
    • Active, not recruiting
    • UMHAT Sveta Marina EAD, Clinic of Internal Diseases
• Czechia
  • Frýdek-Místek, Czechia, 738 01
    • Withdrawn
    • MUDr. Petr Buček s.r.o.
  • Hodonín, Czechia, 695 01
    • Withdrawn
    • CTC Hodonin s.r.o.
  • Prague, Czechia, 100 34
    • Withdrawn
    • FNKV-Internal Clinic-Nephrology
  • Prague, Czechia, 140 00
    • Withdrawn
    • DiaVize s.r.o.
  • Prague, Czechia, 140 21
    • Withdrawn
    • IKEM Klinika nefrologie
  • Prague, Czechia, 160 00
    • Withdrawn
    • Fledip s.r.o.
  • Smiřice, Czechia, 503 03
    • Withdrawn
    • Internist Care s.r.o.
  • Český Krumlov, Czechia, 381 01
    • Withdrawn
    • Nemocnice Český Krumlov, a.s.
• India
  • Andhra Pradesh
    • Guntur, Andhra Pradesh, India, 522001
      • Not yet recruiting
      • Endolife Specialty Hospitals
  • Karnataka
    • Bengaluru, Karnataka, India, 560054
      • Not yet recruiting
      • MS Ramaiah
  • Kerala
    • Kozhikode, Kerala, India, 673008
      • Not yet recruiting
      • Government Medical College, Kozhikode
  • Rajasthan
    • Jaipur, Rajasthan, India, 302004
      • Not yet recruiting
      • SMS Medical College & Hospital
    • Jaipur, Rajasthan, India, 302006
      • Not yet recruiting
      • Diabetes, Thyroid and Endocrine Centre
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Not yet recruiting
      • Nizams Institute of Medical Science
    • Hyderabad, Telangana, India, 500082
      • Not yet recruiting
      • Diabetes Research Center, Hyderabad
• Italy
  • Bergamo, Italy, 24127
    • Completed
    • Azienda Ospedaliera Papa Giovanni XXIII
  • Brescia, Italy, 25121
    • Active, not recruiting
    • Azienda Ospedaliera Spedali Civili di Brescia
  • Milan, Italy, 20157
    • Active, not recruiting
    • Azienda Ospedaliera Luigi Sacco
  • Pisa, Italy, 56124
    • Not yet recruiting
    • Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello
  • Roma, Italy, 00168
    • Active, not recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCS
  • Abbruzzo
    • L’Aquila, Abbruzzo, Italy, 67100
      • Active, not recruiting
      • ASL Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UOC Diabetologia
  • Abruzzo
    • Chieti, Abruzzo, Italy, 66100
      • Active, not recruiting
      • Università degli studi G. D'Annunzio Chieti Pescara - CAST
  • BO
    • Bologna, BO, Italy, 40138
      • Active, not recruiting
      • A.O.U. Bologna_ Policlinico S.Orsola Malpighi
• Japan
  • Aichi, Japan, 468-0009
    • Active, not recruiting
    • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
  • Ibaraki, Japan, 311-0113
    • Recruiting
    • Naka Kinen Clinic_Internal medicine
  • Ibaraki, Japan, 311-0113
    • Active, not recruiting
    • Naka Kinen Clinic_Internal medicine
  • Kanagawa, Japan, 251-8550
    • Recruiting
    • Fujisawa City Hospital_Kidney internal medicine
  • Kanagawa, Japan, 251-8550
    • Completed
    • Fujisawa City Hospital_Kidney internal medicine
  • Kita-ku, Tokyo, Japan, 114-0001
    • Active, not recruiting
    • Higashijujo Sakai Diabetes Clinic_Internal Medicine
  • Saitama, Japan, 348-8505
    • Completed
    • Hanyu General Hospital_Internal Medicine
  • Saitama, Japan, 343-8577
    • Active, not recruiting
    • Koshigaya Municipal Hospital_Internal medicine
  • Sendai-shi, Miyagi, Japan, 983-0039
    • Recruiting
    • Shinden Higashi Clinic
  • Sendai-shi, Miyagi, Japan, 983-0039
    • Active, not recruiting
    • Shinden Higashi Clinic_Internal medicine
  • Siga, Japan, 523-0082
    • Recruiting
    • Omihachiman Community Medical Center_Nephrology
  • Siga, Japan, 523-0082
    • Active, not recruiting
    • Omihachiman Community Medical Center_Nephrology
  • Tokyo, Japan, 104-0031
    • Recruiting
    • Fukuwa Clinic
  • Tokyo, Japan, 125-0054
    • Recruiting
    • Kato Clinic of Internal Medicine
  • Tokyo, Japan, 104-0031
    • Recruiting
    • Fukuwa Clinic_Internal Medicine
  • Tokyo, Japan, 103-0027
    • Active, not recruiting
    • Tokyo-Eki Center-building Clinic_Internal Medicine
  • Tokyo, Japan, 104-0031
    • Active, not recruiting
    • Fukuwa Clinic_Internal Medicine
  • Tokyo, Japan, 125-0054
    • Active, not recruiting
    • Kato Clinic of Internal Medicine_Internal Medicine
  • Fukushima, Japan
    • Koriyama-shi, Fukushima, Fukushima, Japan, Japan, 963-8851
      • Active, not recruiting
      • Seino Internal Medicine Clinic_Internal medicine
• Malaysia
  • Kota Bharu, Kelantan, Malaysia, 16150
    • Active, not recruiting
    • Hospital Universiti Sains Malaysia
  • Kuala Lumpur, Malaysia, 50450
    • Active, not recruiting
    • Prince Court Medical Centre
  • Malacca, Malaysia, 75400
    • Active, not recruiting
    • Hospital Melaka
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
      • Recruiting
      • University Malaya Medical Centre
    • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
      • Active, not recruiting
      • University Malaya Medical Centre
  • Perak
    • Ipoh, Perak, Malaysia, 30450
      • Active, not recruiting
      • Hospital Raja Permaisuri Bainun Ipoh
  • Pulau Pinang
    • George Town, Pulau Pinang, Malaysia, 10990
      • Active, not recruiting
      • Hospital Pulau Pinang
  • Sarawak
    • Miri, Sarawak, Malaysia, 98000
      • Active, not recruiting
      • Hospital Miri
    • Sibu, Sarawak, Malaysia, 96000
      • Active, not recruiting
      • Hospital Sibu
  • Selangor
    • Sungai Buloh, Selangor, Malaysia, 47000
      • Active, not recruiting
      • Hospital Sungai Buloh
• Poland
  • Bialystok, Poland, 15-276
    • Recruiting
    • Uniwersytecki Szpital Kliniczny W Bialymstoku
  • Bialystok, Poland, 15-276
    • Active, not recruiting
    • Uniwersytecki Szpital Kliniczny W Bialymstoku
  • Gmina Świecie, Poland, 86-100
    • Not yet recruiting
    • Nowy Szpital Sp. z o.o.
  • Gmina Świecie, Poland, 86-100
    • Active, not recruiting
    • Nowy Szpital Sp. z o.o.
  • Katowice, Poland, 40-752
    • Completed
    • Uniwersyteckie Centrum Kliniczne SUM w Katowicach
  • Lodz, Poland, 90-153
    • Not yet recruiting
    • SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego UM w Lodzi
  • Lodz, Poland, 92-213
    • Active, not recruiting
    • SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
  • Lublin, Poland, 20-333
    • Recruiting
    • Terpa Sp. z o.o. Sp. k.
  • Lublin, Poland, 20-601
    • Completed
    • Zanamed Medical Clinic Sp. z o.o.
  • Olsztyn, Poland, 10-561
    • Completed
    • Wojewodzki Szpital Specjalistyczny w Olsztynie
  • Oświęcim, Poland, 32-600
    • Not yet recruiting
    • Formed 2 Sp. z o.o.
  • Szczecin, Poland, 70-111
    • Not yet recruiting
    • Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
  • Tczew, Poland, 83-110
    • Not yet recruiting
    • Szpitale Tczewskie S.A.
  • Warsaw, Poland, 02-507
    • Active, not recruiting
    • PANSTWOWY INSTYTUT MEDYCZNY MSWiA
  • Wroclaw, Poland, 52-416
    • Completed
    • Centrum Medyczne Oporow
  • Zabrze, Poland, 41-800
    • Not yet recruiting
    • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
  • Kuyavian-Pomeranian Voivodeship
    • Włocławek, Kuyavian-Pomeranian Voivodeship, Poland, 87-800
      • Active, not recruiting
      • Kardio Life - Tomasz Borkowski
  • Lubelskie Voivodeship
    • Lublin, Lubelskie Voivodeship, Poland, 20-333
      • Active, not recruiting
      • Terpa Sp. z o.o. Sp. k.
  • Podkarpackie Voivodeship
    • Rzeszów, Podkarpackie Voivodeship, Poland, 35-301
      • Not yet recruiting
      • Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
• South Korea
  • Busan, South Korea, 49241
    • Active, not recruiting
    • Pusan National University Hospital
  • Gyeonggi-do, South Korea, 471-101
    • Active, not recruiting
    • Hanyang University Guri Hospital
  • Gyeonggi-do, South Korea, 14068
    • Active, not recruiting
    • Hallym UMC_Pyeongchon
  • Seoul, South Korea, 08308
    • Active, not recruiting
    • Korea University Guro Hospital
  • Seoul, South Korea, 06591
    • Completed
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, South Korea, 10444
      • Completed
      • National Health Insurance Corporation Ilsan Hospital
• Spain
  • Barcelona, Spain, 08036
    • Active, not recruiting
    • Hospital Clinic I Provincial
  • Córdoba, Spain, 14004
    • Active, not recruiting
    • Hospital Reina Sofia
  • Córdoba, Spain, 14004
    • Not yet recruiting
    • Hospital Reina Sofia
  • Getafe, Spain, 28905
    • Active, not recruiting
    • Hospital Universitario de Getafe
  • L'Hospitalet de Llobregat, Spain, 08907
    • Active, not recruiting
    • Hospital De Bellvitge
  • L'Hospitalet de Llobregat, Spain, 08907
    • Not yet recruiting
    • Hospital De Bellvitge
  • Madrid, Spain, 28040
    • Active, not recruiting
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28040
    • Active, not recruiting
    • Fundación Jiménez Díaz
  • Madrid, Spain, 28040
    • Not yet recruiting
    • Fundación Jiménez Díaz
  • Seville, Spain, 41003
    • Not yet recruiting
    • Clínica Nuevas Tecnologías en Diabetes y Endocrinología
  • Seville, Spain, 41003
    • Active, not recruiting
    • Clínica Nuevas Tecnologías en Diabetes y Endocrinología
  • Valencia, Spain, 46017
    • Not yet recruiting
    • Hospital Universitario Doctor Peset
  • Valencia, Spain, 46017
    • Active, not recruiting
    • Hospital Universitario Doctor Peset
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01060
    • Active, not recruiting
    • Adana Şehir Eğitim ve Araştırma Hastanesi
  • Ankara, Turkey (Türkiye), 06230
    • Recruiting
    • Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali
  • Ankara, Turkey (Türkiye), 06800
    • Recruiting
    • Ankara Sehir Hastanesi Dahiliye Klinigi
  • Ankara, Turkey (Türkiye), 06800
    • Active, not recruiting
    • Ankara Bilkent Şehir Hastanesi-Dahiliye
  • Ankara, Turkey (Türkiye), 06230
    • Completed
    • Hacettepe Üniversitesi Hastanesi- Nefroloji
  • Gaziantep, Turkey (Türkiye), 27070
    • Recruiting
    • Gaziantep Universitesi Tip Fakultesi Hastanesi
  • Gaziantep, Turkey (Türkiye), 27070
    • Active, not recruiting
    • Gaziantep Üniversitesi Hastanesi- Endokrinoloji
  • Istanbul, Turkey (Türkiye), 34722
    • Recruiting
    • T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital
  • Istanbul, Turkey (Türkiye), 34722
    • Active, not recruiting
    • Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
  • Izmir, Turkey (Türkiye), 35100
    • Recruiting
    • Ege Universitesi Tip Fakultesi Hastanesi
  • Izmir, Turkey (Türkiye), 35100
    • Active, not recruiting
    • Ege Universitesi Hastanesi- Endokrinoloji
  • Kocaeli, Turkey (Türkiye), 41380
    • Recruiting
    • Kocaeli University Nephrology Department
  • Kocaeli, Turkey (Türkiye), 41380
    • Active, not recruiting
    • Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji
  • Melikgazi
    • Kayseri, Melikgazi, Turkey (Türkiye), 38039
      • Active, not recruiting
      • Erciyes Üniversitesi Hastanesi - Nefroloji
• United States
  • California
    • San Dimas, California, United States, 91773
      • Active, not recruiting
      • N America Res Inst - San Dimas
    • San Ramon, California, United States, 94583
      • Active, not recruiting
      • NorCal Endocrinology and Internal Medicine
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Completed
      • Rocky Mount Reg VA Med-DN
  • Florida
    • Fleming Island, Florida, United States, 32003
      • Active, not recruiting
      • Northeast Research Institute
    • Hollywood, Florida, United States, 33024
      • Active, not recruiting
      • Encore Medical Research LLC
    • Saint Augustine, Florida, United States, 32080
      • Active, not recruiting
      • Northeast Research Institute
    • Winter Haven, Florida, United States, 33880
      • Completed
      • Clinical Research of Cent FL
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Completed
      • Endeavor Health
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Active, not recruiting
      • Velocity Clin. Res Valparaiso
  • Michigan
    • Flint, Michigan, United States, 48532
      • Completed
      • Elite Research Center
  • Missouri
    • Kansas City, Missouri, United States, 64111-5964
      • Active, not recruiting
      • Clinical Research Consultants
  • New York
    • Albany, New York, United States, 12203
      • Active, not recruiting
      • Albany Medical College
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Active, not recruiting
      • Carteret Medical Group
    • Winston-Salem, North Carolina, United States, 27103
      • Active, not recruiting
      • Brookview Hills Research Associates, LLC
  • Texas
    • El Paso, Texas, United States, 79902
      • Active, not recruiting
      • DaVita Clinical Research
    • San Antonio, Texas, United States, 78212
      • Active, not recruiting
      • Clinical Advancement Center
    • San Antonio, Texas, United States, 78251
      • Completed
      • Tekton Research
  • Washington
    • Spokane, Washington, United States, 99204
      • Active, not recruiting
      • Providence Medical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.
Placebo Comparator: 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.
Experimental: 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.
Placebo Comparator: 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.
Experimental: 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.
Placebo Comparator: 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.
Experimental: 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.
Placebo Comparator: 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.
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From baseline (week 0) to end of treatment (week 36)
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).	From baseline (week 0) to end of treatment (week 36)
Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 36)
Achievement of greater than or equal to (≥) 5 percentage (%) weight reduction	Measured as count of participants.	From baseline (week 0) to end of treatment (week 36)
Achievement of greater than or equal to (≥) 10 percentage (%) weight reduction	Measured as count of participants.	From baseline (week 0) to end of treatment (week 36)
Change in waist circumference	Measured in centimetres (cm).	From baseline (week 0) to end of treatment (week 36)
Change in glycated haemoglobin (HbA1c)	Measured in percentage point (%-point).	From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)
Change in systolic blood pressure	Measured in millimetres of mercury (mmHg).	From baseline (week 0) to end of treatment (week 36)
Change in diastolic blood pressure	Measured in millimetres of mercury (mmHg).	From baseline (week 0) to end of treatment (week 36)
Number of treatment emergent adverse events (TEAEs)	Measured as count of events.	From baseline (week 0) to end of study (week 40)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 17, 2026

Study Registration Dates

• First Submitted: November 30, 2024
• First Submitted That Met QC Criteria: November 30, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; semaglutide
• Other Study ID Numbers: NN9541-7841; U1111-1302-5591 (Other Identifier: World Health Organization (WHO)); 2024-510846-15 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No