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NCT06717698PHASE2Recruiting

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

Novo Nordisk A/S

Start Date

12/2/2024

Completion Date

9/17/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

NNC0519-0130

DRUG

Placebo

DRUG

Semaglutide

Interested in This Trial?

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Conditions

Chronic Kidney Disease

Locations

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)