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

Last updated: March 10, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

2

Condition

Kidney Disease

Nephropathy

Kidney Failure

Treatment

NNC0519-0130

Semaglutide

Placebo

Clinical Study ID

NCT06717698
NN9541-7841
U1111-1302-5591
2024-510846-15
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Female of non-childbearing potential, or male.

  • For US only: Female of childbearing potential using highly effectivenon-systemic methods of contraception with low user-dependency at least 2months prior to screening and willingness to continue using it through-out thestudy, 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 beforescreening, 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, orHbA1c of less than (<)6.5 percentage (%) [<48 mmol/mol] if not diagnosed withtype 2 diabetes mellitus.

  • BMI greater than or equal to (≥) 27.0 kilogram per square metre (kg/m^2) atscreening.

  • Kidney impairment defined by serum creatinine and cystatin C-based Egfr greater thanor equal to (≥) 15 and less than (<) 90 mL/min/1.73 m^2.

  • Albuminuria defined by Urine Albumin-to-Creatinine Ratio (UACR) greater than orequal (≥)100 and less than (<) 5000 milligram per gram (mg/g).

  • Treatment with maximum labelled or tolerated dose of an angiotensin convertingenzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless suchtreatment 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

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is ofchildbearing potential and not using highly effective non-systemic contraceptionwith low user-dependency.

  • Lupus nephritis or antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

  • Receiving immunosuppressive therapy for primary or secondary renal disease within 6months prior to screening.

  • Use of any glucagon-like peptide-1 (GLP-1) RA (including medication with GLP-1 RAactivity, e.g., GIP/GLP-1 RA) within 90 days prior to screening.

  • Myocardial infarction, stroke, transient ischaemic attack, or hospitalization forunstable angina pectoris within 180 days before screening.

  • Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days beforescreening.

  • Only applicable for participants with type 2 diabetes (T2D): Uncontrolled andpotentially unstable diabetic retinopathy or diabetic maculopathy. Verified by aneye examination performed within 90 days before screening or in the period betweenscreening and randomisation. Pharmacological pupil-dilation is a requirement unlessusing a digital fundus photography camera specified for non-dilated examination.

  • Presence or history of malignant neoplasms or in situ carcinomas (other than basalor squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of thecervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN))within 5 years before screening.

Study Design

Total Participants: 465
Treatment Group(s): 3
Primary Treatment: NNC0519-0130
Phase: 2
Study Start date:
December 02, 2024
Estimated Completion Date:
September 29, 2026

Connect with a study center

  • Centro Médico CIMEL

    Lanus Este, Buenos Aires B1824KAJ
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Metabólicas

    City of Buenos Aires, C1056ABI
    Argentina

    Active - Recruiting

  • Instituto de Cardiología de Corrientes

    Corrientes, W3400AMY
    Argentina

    Active - Recruiting

  • Instituto de Investigaciones Clinicas

    Mar del Plata, B7600FZN
    Argentina

    Active - Recruiting

  • Centro de Diabetes Curitiba

    Curitiba, Parana 80810-040
    Brazil

    Site Not Available

  • Instituto Pró-Renal Brasil

    Curitiba, Parana 80440-020
    Brazil

    Site Not Available

  • Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV

    Curitiba, Parana 80045-170
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90020-090
    Brazil

    Site Not Available

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

    Porto Alegre, Rio Grande Do Sul 90430-001
    Brazil

    Site Not Available

  • Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos

    Sao Paulo, 04038-002
    Brazil

    Site Not Available

  • Specialized Rehabilitation Hospital Zdrave EAD

    Bankya, 1320
    Bulgaria

    Site Not Available

  • "Medical Centre Acad. Iv. Penchev" EOOD

    Sofia, 1431
    Bulgaria

    Site Not Available

  • "UMHAT "Sveta Anna" Sofia"

    Sofia, 1750
    Bulgaria

    Site Not Available

  • UMHAT Sofiamed

    Sofia, 1750
    Bulgaria

    Site Not Available

  • USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology

    Sofia, 1431
    Bulgaria

    Site Not Available

  • UMHAT Sveta Marina EAD

    Varna, 9010
    Bulgaria

    Site Not Available

  • MUDr. Petr Buček s.r.o.

    Frýdek Místek, 738 01
    Czechia

    Site Not Available

  • CTC Hodonin s.r.o.

    Hodonin, 695 01
    Czechia

    Site Not Available

  • DiaVize s.r.o.

    Praha, 140 00
    Czechia

    Site Not Available

  • FNKV-Internal Clinic-Nephrology

    Praha 10, 100 34
    Czechia

    Site Not Available

  • IKEM Klinika nefrologie

    Praha 4, 140 21
    Czechia

    Site Not Available

  • Fledip s.r.o.

    Praha 6, 160 00
    Czechia

    Site Not Available

  • Internist Care s.r.o.

    Smiřice, 503 03
    Czechia

    Site Not Available

  • Nemocnice Český Krumlov, a.s.

    Český Krumlov, 381 01
    Czechia

    Site Not Available

  • Endolife Specialty Hospitals

    Guntur, Andhra Pradesh 522001
    India

    Site Not Available

  • MS Ramaiah

    Bengaluru, Karnataka 560054
    India

    Site Not Available

  • Government Medical College, Kozhikode

    Kozhikode, Kerala 673008
    India

    Site Not Available

  • Diabetes, Thyroid and Endocrine Centre

    Jaipur, Rajasthan 302006
    India

    Site Not Available

  • SMS Medical College & Hospital

    Jaipur, Rajasthan 302004
    India

    Site Not Available

  • Diabetes Research Center, Hyderabad

    Hyderabad, Telangana 500082
    India

    Site Not Available

  • Nizams Institute of Medical Science

    Hyderabad, Telangana 500082
    India

    Site Not Available

  • Ospedale San Salvatore, Dipartimento Medico ASL1 Abruzzo, UOC Diabetologia

    L'Aquila, Abbruzzo 67100
    Italy

    Site Not Available

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

    Chieti, Abruzzo 66100
    Italy

    Site Not Available

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

    Bologna, BO 40138
    Italy

    Site Not Available

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

    Bologna, BO 40138
    Italy

    Site Not Available

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127
    Italy

    Site Not Available

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25121
    Italy

    Site Not Available

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

    Chieti Scalo, 66100
    Italy

    Site Not Available

  • Azienda Ospedaliera Luigi Sacco

    Milano, 20157
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello

    Pisa, 56124
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168
    Italy

    Site Not Available

  • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

    Aichi, 468-0009
    Japan

    Active - Recruiting

  • Naka Kinen Clinic

    Ibaraki, 311-0113
    Japan

    Active - Recruiting

  • Fujisawa City Hospital_Kidney internal medicine

    Kanagawa, 251-8550
    Japan

    Active - Recruiting

  • Higashijujo Sakai Diabetes Clinic_Internal Medicine

    Kita-ku, Tokyo, 114-0001
    Japan

    Active - Recruiting

  • Hanyu General Hospital_Internal Medicine

    Saitama, 348-8505
    Japan

    Active - Recruiting

  • Koshigaya Municipal Hospital_Internal medicine

    Saitama, 343-8577
    Japan

    Active - Recruiting

  • Shinden Higashi Clinic

    Sendai-shi, Miyagi, 983-0039
    Japan

    Active - Recruiting

  • Omihachiman Community Medical Center_Nephrology

    Siga, 523-0082
    Japan

    Active - Recruiting

  • Kato Clinic of Internal Medicine

    Tokyo, 125-0054
    Japan

    Active - Recruiting

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Active - Recruiting

  • National Health Insurance Corporation Ilsan Hospital

    Goyang, 410-719
    Korea, Republic of

    Active - Recruiting

  • Hallym University Sacred Heart Hospital

    Gyeonggi-Do, 14068
    Korea, Republic of

    Active - Recruiting

  • Hanyang University GURI Hospital

    Gyeonggi-do, 471-101
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul, 08308
    Korea, Republic of

    Active - Recruiting

  • Seoul Saint Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • Hospital Miri

    Sarawak, Miri 98000
    Malaysia

    Site Not Available

  • Hospital Raja Permaisuri Bainun Ipoh

    Ipoh, Perak 30450
    Malaysia

    Active - Recruiting

  • Hospital Sibu

    Sibu, Sarawak 96000
    Malaysia

    Site Not Available

  • University Malaya Medical Centre

    Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur 59100
    Malaysia

    Site Not Available

  • Hospital Universiti Sains Malaysia

    Kota Bharu, Kelantan, 16150
    Malaysia

    Site Not Available

  • Prince Court Medical Centre

    Kuala Lumpur, 50450
    Malaysia

    Site Not Available

  • Hospital Melaka

    Melaka, 75400
    Malaysia

    Active - Recruiting

  • Hospital Pulau Pinang

    Pulau Pinang, 10990
    Malaysia

    Active - Recruiting

  • Hospital Sungai Buloh

    Sungai Buloh, 47000
    Malaysia

    Active - Recruiting

  • Kardio Life

    Włocławek, Kujawsko-pomorskie 87-800
    Poland

    Site Not Available

  • Terpa Sp. z o.o. Sp. k.

    Lublin, Lubelskie Voivodeship 20-333
    Poland

    Site Not Available

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

    Rzeszow, Podkarpackie 35-301
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Białystok, 15-276
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne SUM w Katowicach

    Katowice, 40-752
    Poland

    Site Not Available

  • Zanamed Medical Clinic Sp. z o.o.

    Lublin, 20-601
    Poland

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, 10-561
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie

    Szczecin, 70-111
    Poland

    Site Not Available

  • Szpitale Tczewskie S.A.

    Tczew, 83-110
    Poland

    Site Not Available

  • PANSTWOWY INSTYTUT MEDYCZNY MSWiA

    Warszawa, 02-507
    Poland

    Site Not Available

  • Centrum Medyczne Oporow

    Wroclaw, 52-416
    Poland

    Site Not Available

  • SP ZOZ Centralny Szpital Kliniczny Uniwerystetu Medycznego w Łodzi

    Łódź, 92-213
    Poland

    Site Not Available

  • Nowy Szpital Sp. z o.o.

    Świecie, 86-100
    Poland

    Site Not Available

  • Hospital Clinic i Provincial

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Reina Sofia

    Córdoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario de Getafe

    Getafe, 28905
    Spain

    Site Not Available

  • Hospital de Bellvitge

    Hospitalet de Llobregat, 08907
    Spain

    Site Not Available

  • Fundacion Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Clínica Nuevas Tecnologías en Diabetes y Endocrinología

    Sevilla, 41003
    Spain

    Site Not Available

  • Hospital Universitario Doctor Peset

    Valencia, 46017
    Spain

    Site Not Available

  • Erciyes Universitesi Tip Fakultesi

    Kayseri, Melikgazi 38039
    Turkey

    Active - Recruiting

  • T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan

    Adana, 01000
    Turkey

    Active - Recruiting

  • Ankara Sehir Hastanesi Dahiliye Klinigi

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali

    Ankara, 06230
    Turkey

    Site Not Available

  • Gaziantep Universitesi Tip Fakultesi Hastanesi

    Gaziantep, 27070
    Turkey

    Active - Recruiting

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

    Istanbul, 34722
    Turkey

    Active - Recruiting

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100
    Turkey

    Active - Recruiting

  • Kocaeli University Nephrology Department

    Kocaeli, 41380
    Turkey

    Active - Recruiting

  • N America Res Inst - San Dimas

    San Dimas, California 91773
    United States

    Active - Recruiting

  • NorCal Endocrinology and Internal Medicine

    San Ramon, California 94583
    United States

    Active - Recruiting

  • Rocky Mount Reg VA Med-DN

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Northeast Research Institute

    Fleming Island, Florida 32003
    United States

    Active - Recruiting

  • Encore Medical Research LLC

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Northeast Research Institute

    Saint Augustine, Florida 32080
    United States

    Active - Recruiting

  • Clinical Research of Cent FL

    Winter Haven, Florida 33880
    United States

    Active - Recruiting

  • Endeavor Health

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Velocity Clin. Res Valparaiso

    Valparaiso, Indiana 46383
    United States

    Active - Recruiting

  • Elite Research Center

    Flint, Michigan 48532
    United States

    Active - Recruiting

  • Albany Medical College

    Albany, New York 12203
    United States

    Active - Recruiting

  • Carteret Medical Group

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Brookview Hills Research Associates, LLC

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Clinical Advancement Ctr, PLLC

    San Antonio, Texas 78212
    United States

    Active - Recruiting

  • Tekton Research

    San Antonio, Texas 78251
    United States

    Site Not Available

  • Providence Medical Research Center

    Spokane, Washington 99204
    United States

    Site Not Available

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