Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06717698

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

Led by Novo Nordisk A/S · Updated on 2026-03-11

465

Participants Needed

147

Research Sites

93 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Female of non-childbearing potential or male
  • For US participants: Female of childbearing potential must use highly effective, low user-dependency contraception starting at least 2 months before screening and continue during the study
  • Age 18 years or older at consent
  • Diagnosed with type 2 diabetes at least 180 days before screening or not diagnosed with type 2 diabetes
  • If diagnosed with type 2 diabetes, HbA1c between 6.5% and 10.5% (48-91 mmol/mol); if not diagnosed, HbA1c below 6.5% (<48 mmol/mol)
  • Body mass index (BMI) of 27.0 kg/m² or higher at screening
  • Kidney impairment with estimated glomerular filtration rate (eGFR) between 15 and less than 90 mL/min/1.73 m² based on serum creatinine and cystatin C
  • Urine albumin-to-creatinine ratio (UACR) between 100 and less than 5000 mg/g
  • Stable treatment with maximum labelled or tolerated dose of ACE inhibitor or angiotensin II receptor blocker (ARB) for at least 30 days before screening, unless contraindicated or not tolerated
Not Eligible

You will not qualify if you...

  • Female who is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential not using highly effective non-systemic contraception
  • Presence of lupus nephritis or ANCA-associated vasculitis
  • Receiving immunosuppressive therapy for kidney disease within 6 months before screening
  • Use of any glucagon-like peptide-1 receptor agonist (GLP-1 RA) within 90 days before screening
  • Heart attack, stroke, transient ischemic attack, or hospitalization for unstable angina within 180 days before screening
  • Chronic or intermittent hemodialysis or peritoneal dialysis within 90 days before screening
  • For participants with type 2 diabetes: uncontrolled or unstable diabetic retinopathy or diabetic maculopathy verified by eye exam within 90 days before screening
  • History or presence of malignant cancers or in situ carcinomas (except certain low-risk skin and prostate cancers) within 5 years before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 147 locations

1

N America Res Inst - San Dimas

San Dimas, California, United States, 91773

Active, Not Recruiting

2

NorCal Endocrinology and Internal Medicine

San Ramon, California, United States, 94583

Active, Not Recruiting

3

Rocky Mount Reg VA Med-DN

Aurora, Colorado, United States, 80045

Completed

4

Northeast Research Institute

Fleming Island, Florida, United States, 32003

Active, Not Recruiting

5

Encore Medical Research LLC

Hollywood, Florida, United States, 33024

Active, Not Recruiting

6

Northeast Research Institute

Saint Augustine, Florida, United States, 32080

Active, Not Recruiting

7

Clinical Research of Cent FL

Winter Haven, Florida, United States, 33880

Completed

8

Endeavor Health

Skokie, Illinois, United States, 60077

Completed

9

Velocity Clin. Res Valparaiso

Valparaiso, Indiana, United States, 46383

Active, Not Recruiting

10

Elite Research Center

Flint, Michigan, United States, 48532

Completed

11

Clinical Research Consultants

Kansas City, Missouri, United States, 64111-5964

Active, Not Recruiting

12

Albany Medical College

Albany, New York, United States, 12203

Active, Not Recruiting

13

Carteret Medical Group

Morehead City, North Carolina, United States, 28557

Active, Not Recruiting

14

Brookview Hills Research Associates, LLC

Winston-Salem, North Carolina, United States, 27103

Active, Not Recruiting

15

Davita Clinical Research

El Paso, Texas, United States, 79902

Active, Not Recruiting

16

Clinical Advancement Center

San Antonio, Texas, United States, 78212

Active, Not Recruiting

17

Tekton Research

San Antonio, Texas, United States, 78251

Completed

18

Providence Medical Research Center

Spokane, Washington, United States, 99204

Active, Not Recruiting

19

Centro Médico CIMEL

Lanús Este, Buenos Aires, Argentina, B1824KAJ

Active, Not Recruiting

20

Renalida

Mar del Plata, Buenos Aires, Argentina, B7600

Active, Not Recruiting

21

Centro de Investigaciones Metabólicas

City of Buenos Aires, Argentina, C1056ABI

Active, Not Recruiting

22

Instituto de Cardiología de Corrientes

Corrientes, Argentina, W3400AMY

Active, Not Recruiting

23

Instituto de Investigaciones Clinicas Mar Del Plata

Mar del Plata, Argentina, B7600FZN

Active, Not Recruiting

24

Castle Hill Medical Centre

Castle Hill, New South Wales, Australia, 2154

Active, Not Recruiting

25

Gosford Renal Research

Gosford, New South Wales, Australia, 2250

Active, Not Recruiting

26

Heart of Australia

Chelmer, Queensland, Australia, 4068

Active, Not Recruiting

27

Melbourne Renal Research Group

Reservoir, Victoria, Australia, 3073

Not Yet Recruiting

28

Sunshine Hospital - Western Centre for Health Research and Education

St Albans, Victoria, Australia, 3021

Active, Not Recruiting

29

Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV

Curitiba, Paraná, Brazil, 80045-110

Active, Not Recruiting

30

Instituto Pró-Renal Brasil

Curitiba, Paraná, Brazil, 80440-020

Active, Not Recruiting

31

Centro de Diabetes Curitiba

Curitiba, Paraná, Brazil, 80810-040

Active, Not Recruiting

32

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil, 90020-090

Active, Not Recruiting

33

Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

Porto Alegre, Rio Grande do Sul, Brazil, 90430-001

Active, Not Recruiting

34

Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos

São Paulo, Brazil, 04038-002

Active, Not Recruiting

35

SRH - Zdrave EAD

Bankya, Bulgaria, 1320

Active, Not Recruiting

36

Medical centre Zdrave 1 OOD

Kozloduy, Bulgaria, 3320

Active, Not Recruiting

37

Nader Yabrudi - ASMPVBE Individual practice

Smolyan, Bulgaria, 4700

Active, Not Recruiting

38

Medical Centre Acad. Iv. Penchev EOOD

Sofia, Bulgaria, 1431

Completed

39

Medical Centre Acad. Iv. Penchev EOOD

Sofia, Bulgaria, 1431

Active, Not Recruiting

40

USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology

Sofia, Bulgaria, 1431

Active, Not Recruiting

41

UMHAT Sofiamed EAD

Sofia, Bulgaria, 1750

Active, Not Recruiting

42

UMHAT Sveta Anna Sofia AD, Second Clinic of Internal Diseases

Sofia, Bulgaria, 1750

Active, Not Recruiting

43

UMHAT Sveta Marina EAD, Clinic of Internal Diseases

Varna, Bulgaria, 9010

Active, Not Recruiting

44

Nemocnice Český Krumlov, a.s.

Český Krumlov, Czechia, 381 01

Withdrawn

45

MUDr. Petr Buček s.r.o.

Frýdek-Místek, Czechia, 738 01

Withdrawn

46

CTC Hodonin s.r.o.

Hodonín, Czechia, 695 01

Withdrawn

47

FNKV-Internal Clinic-Nephrology

Prague, Czechia, 100 34

Withdrawn

48

DiaVize s.r.o.

Prague, Czechia, 140 00

Withdrawn

49

IKEM Klinika nefrologie

Prague, Czechia, 140 21

Withdrawn

50

Fledip s.r.o.

Prague, Czechia, 160 00

Withdrawn

51

Internist Care s.r.o.

Smiřice, Czechia, 503 03

Withdrawn

52

Endolife Specialty Hospitals

Guntur, Andhra Pradesh, India, 522001

Not Yet Recruiting

53

MS Ramaiah

Bengaluru, Karnataka, India, 560054

Not Yet Recruiting

54

Government Medical College, Kozhikode

Kozhikode, Kerala, India, 673008

Not Yet Recruiting

55

SMS Medical College & Hospital

Jaipur, Rajasthan, India, 302004

Not Yet Recruiting

56

Diabetes, Thyroid and Endocrine Centre

Jaipur, Rajasthan, India, 302006

Not Yet Recruiting

57

Diabetes Research Center, Hyderabad

Hyderabad, Telangana, India, 500082

Not Yet Recruiting

58

Nizams Institute of Medical Science

Hyderabad, Telangana, India, 500082

Not Yet Recruiting

59

ASL Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UOC Diabetologia

L’Aquila, Abbruzzo, Italy, 67100

Active, Not Recruiting

60

Università degli studi G. D'Annunzio Chieti Pescara - CAST

Chieti, Abruzzo, Italy, 66100

Active, Not Recruiting

61

A.O.U. Bologna_ Policlinico S.Orsola Malpighi

Bologna, BO, Italy, 40138

Active, Not Recruiting

62

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Italy, 24127

Completed

63

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy, 25121

Active, Not Recruiting

64

Azienda Ospedaliera Luigi Sacco

Milan, Italy, 20157

Active, Not Recruiting

65

Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello

Pisa, Italy, 56124

Not Yet Recruiting

66

Fondazione Policlinico Universitario Agostino Gemelli IRCS

Roma, Italy, 00168

Active, Not Recruiting

67

Seino Internal Medicine Clinic_Internal medicine

Koriyama-shi, Fukushima, Fukushima, Japan, Japan, 963-8851

Active, Not Recruiting

68

TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

Aichi, Japan, 468-0009

Active, Not Recruiting

69

Naka Kinen Clinic_Internal medicine

Ibaraki, Japan, 311-0113

Active, Not Recruiting

70

Naka Kinen Clinic_Internal medicine

Ibaraki, Japan, 311-0113

Actively Recruiting

71

Fujisawa City Hospital_Kidney internal medicine

Kanagawa, Japan, 251-8550

Completed

72

Fujisawa City Hospital_Kidney internal medicine

Kanagawa, Japan, 251-8550

Actively Recruiting

73

Higashijujo Sakai Diabetes Clinic_Internal Medicine

Kita-ku, Tokyo, Japan, 114-0001

Active, Not Recruiting

74

Koshigaya Municipal Hospital_Internal medicine

Saitama, Japan, 343-8577

Active, Not Recruiting

75

Hanyu General Hospital_Internal Medicine

Saitama, Japan, 348-8505

Completed

76

Shinden Higashi Clinic_Internal medicine

Sendai-shi, Miyagi, Japan, 983-0039

Active, Not Recruiting

77

Shinden Higashi Clinic

Sendai-shi, Miyagi, Japan, 983-0039

Actively Recruiting

78

Omihachiman Community Medical Center_Nephrology

Siga, Japan, 523-0082

Active, Not Recruiting

79

Omihachiman Community Medical Center_Nephrology

Siga, Japan, 523-0082

Actively Recruiting

80

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, Japan, 103-0027

Active, Not Recruiting

81

Fukuwa Clinic_Internal Medicine

Tokyo, Japan, 104-0031

Active, Not Recruiting

82

Fukuwa Clinic_Internal Medicine

Tokyo, Japan, 104-0031

Actively Recruiting

83

Fukuwa Clinic

Tokyo, Japan, 104-0031

Actively Recruiting

84

Kato Clinic of Internal Medicine_Internal Medicine

Tokyo, Japan, 125-0054

Active, Not Recruiting

85

Kato Clinic of Internal Medicine

Tokyo, Japan, 125-0054

Actively Recruiting

86

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia, 59100

Actively Recruiting

87

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, Malaysia, 59100

Active, Not Recruiting

88

Hospital Raja Permaisuri Bainun Ipoh

Ipoh, Perak, Malaysia, 30450

Active, Not Recruiting

89

Hospital Pulau Pinang

George Town, Pulau Pinang, Malaysia, 10990

Active, Not Recruiting

90

Hospital Miri

Miri, Sarawak, Malaysia, 98000

Active, Not Recruiting

91

Hospital Sibu

Sibu, Sarawak, Malaysia, 96000

Active, Not Recruiting

92

Hospital Sungai Buloh

Sungai Buloh, Selangor, Malaysia, 47000

Active, Not Recruiting

93

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, Malaysia, 16150

Active, Not Recruiting

94

Prince Court Medical Centre

Kuala Lumpur, Malaysia, 50450

Active, Not Recruiting

95

Hospital Melaka

Malacca, Malaysia, 75400

Active, Not Recruiting

96

Kardio Life - Tomasz Borkowski

Włocławek, Kuyavian-Pomeranian Voivodeship, Poland, 87-800

Active, Not Recruiting

97

Terpa Sp. z o.o. Sp. k.

Lublin, Lubelskie Voivodeship, Poland, 20-333

Active, Not Recruiting

98

Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie

Rzeszów, Podkarpackie Voivodeship, Poland, 35-301

Not Yet Recruiting

99

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland, 15-276

Active, Not Recruiting

100

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland, 15-276

Actively Recruiting

101

Nowy Szpital Sp. z o.o.

Gmina Świecie, Poland, 86-100

Active, Not Recruiting

102

Nowy Szpital Sp. z o.o.

Gmina Świecie, Poland, 86-100

Not Yet Recruiting

103

Uniwersyteckie Centrum Kliniczne SUM w Katowicach

Katowice, Poland, 40-752

Completed

104

SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego UM w Lodzi

Lodz, Poland, 90-153

Not Yet Recruiting

105

SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

Lodz, Poland, 92-213

Active, Not Recruiting

106

Terpa Sp. z o.o. Sp. k.

Lublin, Poland, 20-333

Actively Recruiting

107

Zanamed Medical Clinic Sp. z o.o.

Lublin, Poland, 20-601

Completed

108

Wojewodzki Szpital Specjalistyczny w Olsztynie

Olsztyn, Poland, 10-561

Completed

109

Formed 2 Sp. z o.o.

Oświęcim, Poland, 32-600

Not Yet Recruiting

110

Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie

Szczecin, Poland, 70-111

Not Yet Recruiting

111

Szpitale Tczewskie S.A.

Tczew, Poland, 83-110

Not Yet Recruiting

112

PANSTWOWY INSTYTUT MEDYCZNY MSWiA

Warsaw, Poland, 02-507

Active, Not Recruiting

113

Centrum Medyczne Oporow

Wroclaw, Poland, 52-416

Completed

114

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko

Zabrze, Poland, 41-800

Not Yet Recruiting

115

National Health Insurance Corporation Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea, 10444

Completed

116

Pusan National University Hospital

Busan, South Korea, 49241

Active, Not Recruiting

117

Hallym UMC_Pyeongchon

Gyeonggi-do, South Korea, 14068

Active, Not Recruiting

118

Hanyang University GURI Hospital

Gyeonggi-do, South Korea, 471-101

Active, Not Recruiting

119

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, South Korea, 06591

Completed

120

Korea University Guro Hospital

Seoul, South Korea, 08308

Active, Not Recruiting

121

Hospital Clinic i Provincial

Barcelona, Spain, 08036

Active, Not Recruiting

122

Hospital Reina Sofia

Córdoba, Spain, 14004

Active, Not Recruiting

123

Hospital Reina Sofia

Córdoba, Spain, 14004

Not Yet Recruiting

124

Hospital Universitario de Getafe

Getafe, Spain, 28905

Active, Not Recruiting

125

Hospital de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Active, Not Recruiting

126

Hospital de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Not Yet Recruiting

127

Fundacion Jiménez Díaz

Madrid, Spain, 28040

Active, Not Recruiting

128

Fundacion Jiménez Díaz

Madrid, Spain, 28040

Not Yet Recruiting

129

Hospital Clínico San Carlos

Madrid, Spain, 28040

Active, Not Recruiting

130

Clínica Nuevas Tecnologías en Diabetes y Endocrinología

Seville, Spain, 41003

Active, Not Recruiting

131

Clínica Nuevas Tecnologías en Diabetes y Endocrinología

Seville, Spain, 41003

Not Yet Recruiting

132

Hospital Universitario Doctor Peset

Valencia, Spain, 46017

Active, Not Recruiting

133

Hospital Universitario Doctor Peset

Valencia, Spain, 46017

Not Yet Recruiting

134

Erciyes Üniversitesi Hastanesi - Nefroloji

Kayseri, Melikgazi, Turkey (Türkiye), 38039

Active, Not Recruiting

135

Adana Şehir Eğitim ve Araştırma Hastanesi

Adana, Turkey (Türkiye), 01060

Active, Not Recruiting

136

Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali

Ankara, Turkey (Türkiye), 06230

Actively Recruiting

137

Hacettepe Üniversitesi Hastanesi- Nefroloji

Ankara, Turkey (Türkiye), 06230

Completed

138

Ankara Bilkent Şehir Hastanesi-Dahiliye

Ankara, Turkey (Türkiye), 06800

Active, Not Recruiting

139

Ankara Sehir Hastanesi Dahiliye Klinigi

Ankara, Turkey (Türkiye), 06800

Actively Recruiting

140

Gaziantep Universitesi Tip Fakultesi Hastanesi

Gaziantep, Turkey (Türkiye), 27070

Actively Recruiting

141

Gaziantep Üniversitesi Hastanesi- Endokrinoloji

Gaziantep, Turkey (Türkiye), 27070

Active, Not Recruiting

142

Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye

Istanbul, Turkey (Türkiye), 34722

Active, Not Recruiting

143

T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye), 34722

Actively Recruiting

144

Ege Universitesi Hastanesi- Endokrinoloji

Izmir, Turkey (Türkiye), 35100

Active, Not Recruiting

145

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, Turkey (Türkiye), 35100

Actively Recruiting

146

Kocaeli University Nephrology Department

Kocaeli, Turkey (Türkiye), 41380

Actively Recruiting

147

Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji

Kocaeli, Turkey (Türkiye), 41380

Active, Not Recruiting

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Research Team

N

Novo Nordisk

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

9

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