RecruitingPhase 2NCT06717698

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

Sponsor

Novo Nordisk A/S

Enrollment

465 participants

Start Date

Dec 2, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different doses of a new drug called NNC0519-0130 to see how well it can slow kidney damage in people with chronic kidney disease (CKD), with or without type 2 diabetes. Researchers are looking for the best dose that reduces kidney protein leakage (a sign of damage) safely. **You may be eligible if...** - You are 18 or older - You have chronic kidney disease with reduced kidney function (eGFR between 15 and 90 mL/min/1.73m²) - You have significant protein in your urine (UACR between 100 and 5000 mg/g) - You have type 2 diabetes with HbA1c between 6.5% and 10.5%, OR no diabetes with HbA1c below 6.5% - You are on maximum tolerated dose of a blood pressure-protecting kidney medication (ACE inhibitor or ARB) - Your BMI is 27 or above **You may NOT be eligible if...** - You are a woman of childbearing potential (unless in the US and using highly effective contraception) - You have certain other serious medical conditions affecting participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNNC0519-0130

NNC0519-0130 will be administered subcutaneously.

DRUGPlacebo

Placebo matching NNC0519-0130 will be administered subcutaneously.

DRUGSemaglutide

Semaglutide will be administered subcutaneously.

Locations(147)

N America Res Inst - San Dimas

San Dimas, California, United States

NorCal Endocrinology and Internal Medicine

San Ramon, California, United States

Rocky Mount Reg VA Med-DN

Aurora, Colorado, United States

Northeast Research Institute

Fleming Island, Florida, United States

Encore Medical Research LLC

Hollywood, Florida, United States

Northeast Research Institute

Saint Augustine, Florida, United States

Clinical Research of Cent FL

Winter Haven, Florida, United States

Endeavor Health

Skokie, Illinois, United States

Velocity Clin. Res Valparaiso

Valparaiso, Indiana, United States

Elite Research Center

Flint, Michigan, United States

Clinical Research Consultants

Kansas City, Missouri, United States

Albany Medical College

Albany, New York, United States

Carteret Medical Group

Morehead City, North Carolina, United States

Brookview Hills Research Associates, LLC

Winston-Salem, North Carolina, United States

Davita Clinical Research

El Paso, Texas, United States

Clinical Advancement Center

San Antonio, Texas, United States

Tekton Research

San Antonio, Texas, United States

Providence Medical Research Center

Spokane, Washington, United States

Centro Médico CIMEL

Lanús Este, Buenos Aires, Argentina

Renalida

Mar del Plata, Buenos Aires, Argentina

Centro de Investigaciones Metabólicas

City of Buenos Aires, Argentina

Instituto de Cardiología de Corrientes

Corrientes, Argentina

Instituto de Investigaciones Clinicas Mar Del Plata

Mar del Plata, Argentina

Castle Hill Medical Centre

Castle Hill, New South Wales, Australia

Gosford Renal Research

Gosford, New South Wales, Australia

Heart of Australia

Chelmer, Queensland, Australia

Melbourne Renal Research Group

Reservoir, Victoria, Australia

Sunshine Hospital - Western Centre for Health Research and Education

St Albans, Victoria, Australia

Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV

Curitiba, Paraná, Brazil

Instituto Pró-Renal Brasil

Curitiba, Paraná, Brazil

Centro de Diabetes Curitiba

Curitiba, Paraná, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

Porto Alegre, Rio Grande do Sul, Brazil

Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos

São Paulo, Brazil

SRH - Zdrave EAD

Bankya, Bulgaria

Medical centre Zdrave 1 OOD

Kozloduy, Bulgaria

Nader Yabrudi - ASMPVBE Individual practice

Smolyan, Bulgaria

Medical Centre Acad. Iv. Penchev EOOD

Sofia, Bulgaria

Medical Centre Acad. Iv. Penchev EOOD

Sofia, Bulgaria

USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology

Sofia, Bulgaria

UMHAT Sofiamed EAD

Sofia, Bulgaria

UMHAT Sveta Anna Sofia AD, Second Clinic of Internal Diseases

Sofia, Bulgaria

UMHAT Sveta Marina EAD, Clinic of Internal Diseases

Varna, Bulgaria

Nemocnice Český Krumlov, a.s.

Český Krumlov, Czechia

MUDr. Petr Buček s.r.o.

Frýdek-Místek, Czechia

CTC Hodonin s.r.o.

Hodonín, Czechia

FNKV-Internal Clinic-Nephrology

Prague, Czechia

DiaVize s.r.o.

Prague, Czechia

IKEM Klinika nefrologie

Prague, Czechia

Fledip s.r.o.

Prague, Czechia

Internist Care s.r.o.

Smiřice, Czechia

Endolife Specialty Hospitals

Guntur, Andhra Pradesh, India

MS Ramaiah

Bengaluru, Karnataka, India

Government Medical College, Kozhikode

Kozhikode, Kerala, India

SMS Medical College & Hospital

Jaipur, Rajasthan, India

Diabetes, Thyroid and Endocrine Centre

Jaipur, Rajasthan, India

Diabetes Research Center, Hyderabad

Hyderabad, Telangana, India

Nizams Institute of Medical Science

Hyderabad, Telangana, India

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

L’Aquila, Abbruzzo, Italy

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

Chieti, Abruzzo, Italy

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

Bologna, BO, Italy

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Italy

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

Azienda Ospedaliera Luigi Sacco

Milan, Italy

Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello

Pisa, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCS

Roma, Italy

Seino Internal Medicine Clinic_Internal medicine

Koriyama-shi, Fukushima, Fukushima, Japan, Japan

TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

Aichi, Japan

Naka Kinen Clinic_Internal medicine

Ibaraki, Japan

Naka Kinen Clinic_Internal medicine

Ibaraki, Japan

Fujisawa City Hospital_Kidney internal medicine

Kanagawa, Japan

Fujisawa City Hospital_Kidney internal medicine

Kanagawa, Japan

Higashijujo Sakai Diabetes Clinic_Internal Medicine

Kita-ku, Tokyo, Japan

Koshigaya Municipal Hospital_Internal medicine

Saitama, Japan

Hanyu General Hospital_Internal Medicine

Saitama, Japan

Shinden Higashi Clinic_Internal medicine

Sendai-shi, Miyagi, Japan

Shinden Higashi Clinic

Sendai-shi, Miyagi, Japan

Omihachiman Community Medical Center_Nephrology

Siga, Japan

Omihachiman Community Medical Center_Nephrology

Siga, Japan

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, Japan

Fukuwa Clinic_Internal Medicine

Tokyo, Japan

Fukuwa Clinic_Internal Medicine

Tokyo, Japan

Fukuwa Clinic

Tokyo, Japan

Kato Clinic of Internal Medicine_Internal Medicine

Tokyo, Japan

Kato Clinic of Internal Medicine

Tokyo, Japan

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, Malaysia

Hospital Raja Permaisuri Bainun Ipoh

Ipoh, Perak, Malaysia

Hospital Pulau Pinang

George Town, Pulau Pinang, Malaysia

Hospital Miri

Miri, Sarawak, Malaysia

Hospital Sibu

Sibu, Sarawak, Malaysia

Hospital Sungai Buloh

Sungai Buloh, Selangor, Malaysia

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, Malaysia

Prince Court Medical Centre

Kuala Lumpur, Malaysia

Hospital Melaka

Malacca, Malaysia

Kardio Life - Tomasz Borkowski

Włocławek, Kuyavian-Pomeranian Voivodeship, Poland

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

Lublin, Lubelskie Voivodeship, Poland

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

Rzeszów, Podkarpackie Voivodeship, Poland

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland

Nowy Szpital Sp. z o.o.

Gmina Świecie, Poland

Nowy Szpital Sp. z o.o.

Gmina Świecie, Poland

Uniwersyteckie Centrum Kliniczne SUM w Katowicach

Katowice, Poland

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

Lodz, Poland

SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

Lodz, Poland

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

Lublin, Poland

Zanamed Medical Clinic Sp. z o.o.

Lublin, Poland

Wojewodzki Szpital Specjalistyczny w Olsztynie

Olsztyn, Poland

Formed 2 Sp. z o.o.

Oświęcim, Poland

Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie

Szczecin, Poland

Szpitale Tczewskie S.A.

Tczew, Poland

PANSTWOWY INSTYTUT MEDYCZNY MSWiA

Warsaw, Poland

Centrum Medyczne Oporow

Wroclaw, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko

Zabrze, Poland

National Health Insurance Corporation Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Pusan National University Hospital

Busan, South Korea

Hallym UMC_Pyeongchon

Gyeonggi-do, South Korea

Hanyang University GURI Hospital

Gyeonggi-do, South Korea

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

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Hospital Clinic i Provincial

Barcelona, Spain

Hospital Reina Sofia

Córdoba, Spain

Hospital Reina Sofia

Córdoba, Spain

Hospital Universitario de Getafe

Getafe, Spain

Hospital de Bellvitge

L'Hospitalet de Llobregat, Spain

Hospital de Bellvitge

L'Hospitalet de Llobregat, Spain

Fundacion Jiménez Díaz

Madrid, Spain

Fundacion Jiménez Díaz

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Clínica Nuevas Tecnologías en Diabetes y Endocrinología

Seville, Spain

Clínica Nuevas Tecnologías en Diabetes y Endocrinología

Seville, Spain

Hospital Universitario Doctor Peset

Valencia, Spain

Hospital Universitario Doctor Peset

Valencia, Spain

Erciyes Üniversitesi Hastanesi - Nefroloji

Kayseri, Melikgazi, Turkey (Türkiye)

Adana Şehir Eğitim ve Araştırma Hastanesi

Adana, Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali

Ankara, Turkey (Türkiye)

Hacettepe Üniversitesi Hastanesi- Nefroloji

Ankara, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi-Dahiliye

Ankara, Turkey (Türkiye)

Ankara Sehir Hastanesi Dahiliye Klinigi

Ankara, Turkey (Türkiye)

Gaziantep Universitesi Tip Fakultesi Hastanesi

Gaziantep, Turkey (Türkiye)

Gaziantep Üniversitesi Hastanesi- Endokrinoloji

Gaziantep, Turkey (Türkiye)

Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye

Istanbul, Turkey (Türkiye)

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

Istanbul, Turkey (Türkiye)

Ege Universitesi Hastanesi- Endokrinoloji

Izmir, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, Turkey (Türkiye)

Kocaeli University Nephrology Department

Kocaeli, Turkey (Türkiye)

Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji

Kocaeli, Turkey (Türkiye)

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