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

Status: Recruiting
Location: See all (126) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
N America Res Inst - San Dimas
RECRUITING
San Dimas
NorCal Endocrinology and Internal Medicine
RECRUITING
San Ramon
Colorado
Rocky Mount Reg VA Med-DN
WITHDRAWN
Aurora
Florida
Northeast Research Institute
RECRUITING
Fleming Island
Encore Medical Research LLC
RECRUITING
Hollywood
Northeast Research Institute
RECRUITING
Saint Augustine
Clinical Research of Cent FL
RECRUITING
Winter Haven
Illinois
Endeavor Health
WITHDRAWN
Skokie
Indiana
Velocity Clin. Res Valparaiso
RECRUITING
Valparaiso
Michigan
Elite Research Center
RECRUITING
Flint
Missouri
Clinical Research Consultants
RECRUITING
Kansas City
North Carolina
Carteret Medical Group
RECRUITING
Morehead City
Brookview Hills Research Associates, LLC
RECRUITING
Winston-salem
New York
Albany Medical College
RECRUITING
Albany
Texas
Davita Clinical Research
RECRUITING
El Paso
Clinical Advancement Ctr, PLLC
RECRUITING
San Antonio
Tekton Research
RECRUITING
San Antonio
Washington
Providence Medical Research Center
RECRUITING
Spokane
Other Locations
Argentina
Centro de Investigaciones Metabólicas
RECRUITING
City Of Buenos Aires
Instituto de Cardiología de Corrientes
RECRUITING
Corrientes
Centro Médico CIMEL
RECRUITING
Lanús Este
Instituto de Investigaciones Clinicas
RECRUITING
Mar Del Plata
Renalida
RECRUITING
Mar Del Plata
Australia
Castle Hill Medical Centre
RECRUITING
Castle Hill
Heart of Australia
RECRUITING
Chelmer
Gosford Renal Research
RECRUITING
Gosford
Melbourne Renal Research Group
NOT_YET_RECRUITING
Reservoir
Sunshine Hospital
RECRUITING
St Albans
Brazil
Centro de Diabetes Curitiba
RECRUITING
Curitiba
Instituto Pró-Renal Brasil
RECRUITING
Curitiba
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
RECRUITING
Curitiba
Irmandade da Santa Casa de Misericórdia de Porto Alegre
RECRUITING
Porto Alegre
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
RECRUITING
Porto Alegre
Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos
RECRUITING
São Paulo
Bulgaria
Specialized Rehabilitation Hospital Zdrave EAD
RECRUITING
Bankya
Medical centre Zdrave 1 OOD
NOT_YET_RECRUITING
Kozloduy
Nader Yabrudi - ASMPVBE Individual practice
NOT_YET_RECRUITING
Smolyan
Medical Centre Acad. Iv. Penchev EOOD
WITHDRAWN
Sofia
Medical Centre Acad. Iv. Penchev EOOD
RECRUITING
Sofia
UMHAT Sofiamed
RECRUITING
Sofia
UMHAT Sveta Anna Sofia
RECRUITING
Sofia
USHATE Akad. Ivan Penchev Second Clinic of Endocrinology
RECRUITING
Sofia
UMHAT Sveta Marina EAD
RECRUITING
Varna
India
MS Ramaiah
NOT_YET_RECRUITING
Bengaluru
Endolife Specialty Hospitals
NOT_YET_RECRUITING
Guntur
Diabetes Research Center, Hyderabad
NOT_YET_RECRUITING
Hyderabad
Nizams Institute of Medical Science
NOT_YET_RECRUITING
Hyderabad
Diabetes, Thyroid and Endocrine Centre
NOT_YET_RECRUITING
Jaipur
SMS Medical College & Hospital
NOT_YET_RECRUITING
Jaipur
Government Medical College, Kozhikode
NOT_YET_RECRUITING
Kozhikode
Italy
Azienda Ospedaliera Papa Giovanni XXIII
RECRUITING
Bergamo
A.O.U. Bologna_ Policlinico S.Orsola Malpighi
RECRUITING
Bologna
Azienda Ospedaliera Spedali Civili di Brescia
RECRUITING
Brescia
Università degli studi G. D'Annunzio Chieti Pescara - CAST
RECRUITING
Chieti
ASL Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UOC Diabetologia
RECRUITING
L’aquila
Azienda Ospedaliera Luigi Sacco
RECRUITING
Milan
Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello
NOT_YET_RECRUITING
Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCS
RECRUITING
Roma
Japan
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
RECRUITING
Aichi
Naka Kinen Clinic_Internal medicine
RECRUITING
Ibaraki
Fujisawa City Hospital_Kidney internal medicine
RECRUITING
Kanagawa
Higashijujo Sakai Diabetes Clinic_Internal Medicine
RECRUITING
Kita-ku, Tokyo
Seino Internal Medicine Clinic_Internal medicine
RECRUITING
Koriyama-shi
Hanyu General Hospital_Internal Medicine
WITHDRAWN
Saitama
Koshigaya Municipal Hospital_Internal medicine
RECRUITING
Saitama
Shinden Higashi Clinic
RECRUITING
Sendai-shi, Miyagi
Omihachiman Community Medical Center_Nephrology
RECRUITING
Siga
Fukuwa Clinic
RECRUITING
Tokyo
Fukuwa Clinic_Internal Medicine
RECRUITING
Tokyo
Kato Clinic of Internal Medicine
RECRUITING
Tokyo
Kato Clinic of Internal Medicine_Internal Medicine
RECRUITING
Tokyo
Tokyo-Eki Center-building Clinic_Internal Medicine
RECRUITING
Tokyo
Malaysia
Hospital Pulau Pinang
RECRUITING
George Town
Hospital Raja Permaisuri Bainun Ipoh
RECRUITING
Ipoh
Hospital Universiti Sains Malaysia
RECRUITING
Kota Bharu, Kelantan
Prince Court Medical Centre
RECRUITING
Kuala Lumpur
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
University Malaya Medical Centre
RECRUITING
Lembah Pantai
Hospital Melaka
RECRUITING
Malacca
Hospital Miri
RECRUITING
Miri
Hospital Sibu
RECRUITING
Sibu
Hospital Sungai Buloh
RECRUITING
Sungai Buloh
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
RECRUITING
Bialystok
Nowy Szpital Sp. z o.o.
NOT_YET_RECRUITING
Gmina Świecie
Nowy Szpital Sp. z o.o.
RECRUITING
Gmina Świecie
Uniwersyteckie Centrum Kliniczne SUM w Katowicach
WITHDRAWN
Katowice
SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
RECRUITING
Lodz
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego UM w Łodzi
NOT_YET_RECRUITING
Lodz
Terpa Sp. z o.o. Sp. k.
RECRUITING
Lublin
Zanamed Medical Clinic Sp. z o.o.
WITHDRAWN
Lublin
Wojewodzki Szpital Specjalistyczny w Olsztynie
WITHDRAWN
Olsztyn
Formed 2 Sp. z o.o.
NOT_YET_RECRUITING
Oświęcim
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
NOT_YET_RECRUITING
Rzeszów
Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie
NOT_YET_RECRUITING
Szczecin
Szpitale Tczewskie S.A.
NOT_YET_RECRUITING
Tczew
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
RECRUITING
Warsaw
Kardio Life
RECRUITING
Włocławek
Centrum Medyczne Oporow
RECRUITING
Wroclaw
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
NOT_YET_RECRUITING
Zabrze
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
National Health Insurance Corporation Ilsan Hospital
RECRUITING
Goyang
Hallym University Sacred Heart Hospital
RECRUITING
Gyeonggi-do
Hanyang University GURI Hospital
RECRUITING
Gyeonggi-do
Korea University Guro Hospital
RECRUITING
Seoul
The Catholic University of Korea, Seoul ST. Mary's Hospital
RECRUITING
Seoul
Spain
Hospital Clinic i Provincial
RECRUITING
Barcelona
Hospital Reina Sofia
NOT_YET_RECRUITING
Córdoba
Hospital Reina Sofia
RECRUITING
Córdoba
Hospital Universitario de Getafe
RECRUITING
Getafe
Hospital de Bellvitge
NOT_YET_RECRUITING
L'hospitalet De Llobregat
Hospital de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Fundacion Jiménez Díaz
NOT_YET_RECRUITING
Madrid
Fundacion Jiménez Díaz
RECRUITING
Madrid
Hospital Clinico San Carlos
RECRUITING
Madrid
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
RECRUITING
Seville
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
NOT_YET_RECRUITING
Seville
Hospital Universitario Doctor Peset
NOT_YET_RECRUITING
Valencia
Hospital Universitario Doctor Peset
RECRUITING
Valencia
Turkey
T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
RECRUITING
Adana
Ankara Sehir Hastanesi Dahiliye Klinigi
RECRUITING
Ankara
Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali
RECRUITING
Ankara
Gaziantep Universitesi Tip Fakultesi Hastanesi
RECRUITING
Gaziantep
T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital
RECRUITING
Istanbul
Ege Universitesi Tip Fakultesi Hastanesi
RECRUITING
Izmir
Erciyes Universitesi Tip Fakultesi
RECRUITING
Kayseri
Kocaeli University Nephrology Department
RECRUITING
Kocaeli
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2026-09-29
Participants
Target number of participants: 465
Treatments
Experimental: Dosing scheme a: NNC0519-0130
Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Placebo_comparator: Dosing scheme a: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Experimental: Dosing scheme b: NNC0519-0130
Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Placebo_comparator: Dosing scheme b: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Experimental: Dosing scheme c: NNC0519-0130
Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Placebo_comparator: Dosing scheme c: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Experimental: Dosing scheme d: NNC0519-0130
Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Placebo_comparator: Dosing scheme d: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Active_comparator: Dosing scheme e: Semaglutide
Participants will receive once-weekly s.c injections of semaglutide with a dose escalation done until maintenance dose is reached.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov