Phase
Condition
Kidney Disease
Nephropathy
Kidney Failure
Treatment
NNC0519-0130
Semaglutide
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Centro Médico CIMEL
Lanus Este, Buenos Aires B1824KAJ
ArgentinaActive - Recruiting
Centro de Investigaciones Metabólicas
City of Buenos Aires, C1056ABI
ArgentinaActive - Recruiting
Instituto de Cardiología de Corrientes
Corrientes, W3400AMY
ArgentinaActive - Recruiting
Instituto de Investigaciones Clinicas
Mar del Plata, B7600FZN
ArgentinaActive - Recruiting
Centro de Diabetes Curitiba
Curitiba, Parana 80810-040
BrazilSite Not Available
Instituto Pró-Renal Brasil
Curitiba, Parana 80440-020
BrazilSite Not Available
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
Curitiba, Parana 80045-170
BrazilSite Not Available
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande Do Sul 90020-090
BrazilSite Not Available
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
Porto Alegre, Rio Grande Do Sul 90430-001
BrazilSite Not Available
Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos
Sao Paulo, 04038-002
BrazilSite Not Available
Specialized Rehabilitation Hospital Zdrave EAD
Bankya, 1320
BulgariaSite Not Available
"Medical Centre Acad. Iv. Penchev" EOOD
Sofia, 1431
BulgariaSite Not Available
"UMHAT "Sveta Anna" Sofia"
Sofia, 1750
BulgariaSite Not Available
UMHAT Sofiamed
Sofia, 1750
BulgariaSite Not Available
USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
Sofia, 1431
BulgariaSite Not Available
UMHAT Sveta Marina EAD
Varna, 9010
BulgariaSite Not Available
MUDr. Petr Buček s.r.o.
Frýdek Místek, 738 01
CzechiaSite Not Available
CTC Hodonin s.r.o.
Hodonin, 695 01
CzechiaSite Not Available
DiaVize s.r.o.
Praha, 140 00
CzechiaSite Not Available
FNKV-Internal Clinic-Nephrology
Praha 10, 100 34
CzechiaSite Not Available
IKEM Klinika nefrologie
Praha 4, 140 21
CzechiaSite Not Available
Fledip s.r.o.
Praha 6, 160 00
CzechiaSite Not Available
Internist Care s.r.o.
Smiřice, 503 03
CzechiaSite Not Available
Nemocnice Český Krumlov, a.s.
Český Krumlov, 381 01
CzechiaSite Not Available
Endolife Specialty Hospitals
Guntur, Andhra Pradesh 522001
IndiaSite Not Available
MS Ramaiah
Bengaluru, Karnataka 560054
IndiaSite Not Available
Government Medical College, Kozhikode
Kozhikode, Kerala 673008
IndiaSite Not Available
Diabetes, Thyroid and Endocrine Centre
Jaipur, Rajasthan 302006
IndiaSite Not Available
SMS Medical College & Hospital
Jaipur, Rajasthan 302004
IndiaSite Not Available
Diabetes Research Center, Hyderabad
Hyderabad, Telangana 500082
IndiaSite Not Available
Nizams Institute of Medical Science
Hyderabad, Telangana 500082
IndiaSite Not Available
Ospedale San Salvatore, Dipartimento Medico ASL1 Abruzzo, UOC Diabetologia
L'Aquila, Abbruzzo 67100
ItalySite Not Available
Università degli studi G. D'Annunzio Chieti Pescara - CAST
Chieti, Abruzzo 66100
ItalySite Not Available
A.O.U. Bologna_ Policlinico S.Orsola Malpighi
Bologna, BO 40138
ItalySite Not Available
A.O.U. Policlinico S.Orsola Malpighi
Bologna, BO 40138
ItalySite Not Available
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127
ItalySite Not Available
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25121
ItalySite Not Available
Università degli studi G. D'Annunzio Chieti Pescara - CAST
Chieti Scalo, 66100
ItalySite Not Available
Azienda Ospedaliera Luigi Sacco
Milano, 20157
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello
Pisa, 56124
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
ItalySite Not Available
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
Aichi, 468-0009
JapanActive - Recruiting
Naka Kinen Clinic
Ibaraki, 311-0113
JapanActive - Recruiting
Fujisawa City Hospital_Kidney internal medicine
Kanagawa, 251-8550
JapanActive - Recruiting
Higashijujo Sakai Diabetes Clinic_Internal Medicine
Kita-ku, Tokyo, 114-0001
JapanActive - Recruiting
Hanyu General Hospital_Internal Medicine
Saitama, 348-8505
JapanActive - Recruiting
Koshigaya Municipal Hospital_Internal medicine
Saitama, 343-8577
JapanActive - Recruiting
Shinden Higashi Clinic
Sendai-shi, Miyagi, 983-0039
JapanActive - Recruiting
Omihachiman Community Medical Center_Nephrology
Siga, 523-0082
JapanActive - Recruiting
Kato Clinic of Internal Medicine
Tokyo, 125-0054
JapanActive - Recruiting
Pusan National University Hospital
Busan, 49241
Korea, Republic ofActive - Recruiting
National Health Insurance Corporation Ilsan Hospital
Goyang, 410-719
Korea, Republic ofActive - Recruiting
Hallym University Sacred Heart Hospital
Gyeonggi-Do, 14068
Korea, Republic ofActive - Recruiting
Hanyang University GURI Hospital
Gyeonggi-do, 471-101
Korea, Republic ofActive - Recruiting
Korea University Guro Hospital
Seoul, 08308
Korea, Republic ofActive - Recruiting
Seoul Saint Mary's Hospital
Seoul, 06591
Korea, Republic ofActive - Recruiting
Hospital Miri
Sarawak, Miri 98000
MalaysiaSite Not Available
Hospital Raja Permaisuri Bainun Ipoh
Ipoh, Perak 30450
MalaysiaActive - Recruiting
Hospital Sibu
Sibu, Sarawak 96000
MalaysiaSite Not Available
University Malaya Medical Centre
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur 59100
MalaysiaSite Not Available
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
MalaysiaSite Not Available
Prince Court Medical Centre
Kuala Lumpur, 50450
MalaysiaSite Not Available
Hospital Melaka
Melaka, 75400
MalaysiaActive - Recruiting
Hospital Pulau Pinang
Pulau Pinang, 10990
MalaysiaActive - Recruiting
Hospital Sungai Buloh
Sungai Buloh, 47000
MalaysiaActive - Recruiting
Kardio Life
Włocławek, Kujawsko-pomorskie 87-800
PolandSite Not Available
Terpa Sp. z o.o. Sp. k.
Lublin, Lubelskie Voivodeship 20-333
PolandSite Not Available
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
Rzeszow, Podkarpackie 35-301
PolandSite Not Available
Uniwersytecki Szpital Kliniczny w Bialymstoku
Białystok, 15-276
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne SUM w Katowicach
Katowice, 40-752
PolandSite Not Available
Zanamed Medical Clinic Sp. z o.o.
Lublin, 20-601
PolandSite Not Available
Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn, 10-561
PolandSite Not Available
Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie
Szczecin, 70-111
PolandSite Not Available
Szpitale Tczewskie S.A.
Tczew, 83-110
PolandSite Not Available
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warszawa, 02-507
PolandSite Not Available
Centrum Medyczne Oporow
Wroclaw, 52-416
PolandSite Not Available
SP ZOZ Centralny Szpital Kliniczny Uniwerystetu Medycznego w Łodzi
Łódź, 92-213
PolandSite Not Available
Nowy Szpital Sp. z o.o.
Świecie, 86-100
PolandSite Not Available
Hospital Clinic i Provincial
Barcelona, 08036
SpainSite Not Available
Hospital Reina Sofia
Córdoba, 14004
SpainSite Not Available
Hospital Universitario de Getafe
Getafe, 28905
SpainSite Not Available
Hospital de Bellvitge
Hospitalet de Llobregat, 08907
SpainSite Not Available
Fundacion Jiménez Díaz
Madrid, 28040
SpainSite Not Available
Hospital Clinico San Carlos
Madrid, 28040
SpainSite Not Available
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Sevilla, 41003
SpainSite Not Available
Hospital Universitario Doctor Peset
Valencia, 46017
SpainSite Not Available
Erciyes Universitesi Tip Fakultesi
Kayseri, Melikgazi 38039
TurkeyActive - Recruiting
T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
Adana, 01000
TurkeyActive - Recruiting
Ankara Sehir Hastanesi Dahiliye Klinigi
Ankara, 06800
TurkeyActive - Recruiting
Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali
Ankara, 06230
TurkeySite Not Available
Gaziantep Universitesi Tip Fakultesi Hastanesi
Gaziantep, 27070
TurkeyActive - Recruiting
T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, 34722
TurkeyActive - Recruiting
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35100
TurkeyActive - Recruiting
Kocaeli University Nephrology Department
Kocaeli, 41380
TurkeyActive - Recruiting
N America Res Inst - San Dimas
San Dimas, California 91773
United StatesActive - Recruiting
NorCal Endocrinology and Internal Medicine
San Ramon, California 94583
United StatesActive - Recruiting
Rocky Mount Reg VA Med-DN
Aurora, Colorado 80045
United StatesSite Not Available
Northeast Research Institute
Fleming Island, Florida 32003
United StatesActive - Recruiting
Encore Medical Research LLC
Hollywood, Florida 33021
United StatesActive - Recruiting
Northeast Research Institute
Saint Augustine, Florida 32080
United StatesActive - Recruiting
Clinical Research of Cent FL
Winter Haven, Florida 33880
United StatesActive - Recruiting
Endeavor Health
Skokie, Illinois 60077
United StatesSite Not Available
Velocity Clin. Res Valparaiso
Valparaiso, Indiana 46383
United StatesActive - Recruiting
Elite Research Center
Flint, Michigan 48532
United StatesActive - Recruiting
Albany Medical College
Albany, New York 12203
United StatesActive - Recruiting
Carteret Medical Group
Morehead City, North Carolina 28557
United StatesActive - Recruiting
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
Clinical Advancement Ctr, PLLC
San Antonio, Texas 78212
United StatesActive - Recruiting
Tekton Research
San Antonio, Texas 78251
United StatesSite Not Available
Providence Medical Research Center
Spokane, Washington 99204
United StatesSite Not Available
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