Clinical trial NCT06717698: A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Kidney Disease
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-12-05
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Change in urinary albumin-to-creatinine ratio (UACR) at week 12
timeFrame: From baseline (week 0) to end of a given maintenance dose period (week 12)
measure: Change in urinary albumin-to-creatinine ratio (UACR) at week 24
timeFrame: From baseline (week 0) to end of a given maintenance dose period (week 24)
measure: Change in urinary albumin-to-creatinine ratio (UACR) at week 36
timeFrame: From baseline (week 0) to end of a given maintenance dose period (week 36)
Secondary outcomes:
measure: Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021)
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in estimated glomerular filtration rate (eGFR) (creatinine-based CKD-EPI 2021)
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Achievement of greater than or equal to (≥) 5 percentage (%) weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Achievement of greater than or equal to (≥) 10 percentage (%) weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in glycated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)
measure: Change in systolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in diastolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From baseline (week 0) to end of study (week 40)
Other outcomes:
Locations:
city: San Dimas
country: United States
facility: N America Res Inst - San Dimas
state: California
city: San Ramon
country: United States
facility: NorCal Endocrinology and Internal Medicine
state: California
city: Aurora
country: United States
facility: Rocky Mount Reg VA Med-DN
state: Colorado
city: Fleming Island
country: United States
facility: Northeast Research Institute
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research LLC
state: Florida
city: Saint Augustine
country: United States
facility: Northeast Research Institute
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Cent FL
state: Florida
city: Skokie
country: United States
facility: Endeavor Health
state: Illinois
city: Valparaiso
country: United States
facility: Velocity Clin. Res Valparaiso
state: Indiana
city: Flint
country: United States
facility: Elite Research Center
state: Michigan
city: Kansas City
country: United States
facility: Clinical Research Consultants
state: Missouri
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Winston-Salem
country: United States
facility: Brookview Hills Research Associates, LLC
state: North Carolina
city: El Paso
country: United States
facility: Davita Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Advancement Ctr, PLLC
state: Texas
city: San Antonio
country: United States
facility: Tekton Research
state: Texas
city: Spokane
country: United States
facility: Providence Medical Research Center
state: Washington
city: Lanus Este
country: Argentina
facility: Centro Médico CIMEL
state: Buenos Aires
city: City of Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas
city: Corrientes
country: Argentina
facility: Instituto de Cardiología de Corrientes
city: Mar Del Plata, Buenos Aires
country: Argentina
facility: Renalida
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas
city: Castle Hill
country: Australia
facility: Castle Hill Medical Centre
state: New South Wales
city: Gosford
country: Australia
facility: Gosford Renal Research
state: New South Wales
city: Chelmer
country: Australia
facility: Heart of Australia
state: Queensland
city: Reservoir
country: Australia
facility: Melbourne Renal Research Group
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Curitiba
country: Brazil
facility: Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
state: Parana
city: Curitiba
country: Brazil
facility: Instituto Pró-Renal Brasil
state: Parana
city: Curitiba
country: Brazil
facility: Centro de Diabetes Curitiba
state: Parana
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos
city: Bankya
country: Bulgaria
facility: Specialized Rehabilitation Hospital Zdrave EAD
city: Sofia
country: Bulgaria
facility: "Medical Centre Acad. Iv. Penchev" EOOD
city: Sofia
country: Bulgaria
facility: "Medical Centre Acad. Iv. Penchev" EOOD
city: Sofia
country: Bulgaria
facility: USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
city: Sofia
country: Bulgaria
facility: "UMHAT "Sveta Anna" Sofia"
city: Sofia
country: Bulgaria
facility: UMHAT Sofiamed
city: Varna
country: Bulgaria
facility: UMHAT Sveta Marina EAD
city: Frýdek Místek
country: Czechia
facility: MUDr. Petr Buček s.r.o.
city: Hodonin
country: Czechia
facility: CTC Hodonin s.r.o.
city: Praha 10
country: Czechia
facility: FNKV-Internal Clinic-Nephrology
city: Praha 4
country: Czechia
facility: IKEM Klinika nefrologie
city: Praha 6
country: Czechia
facility: Fledip s.r.o.
city: Praha
country: Czechia
facility: DiaVize s.r.o.
city: Smiřice
country: Czechia
facility: Internist Care s.r.o.
city: Český Krumlov
country: Czechia
facility: Nemocnice Český Krumlov, a.s.
city: Guntur
country: India
facility: Endolife Specialty Hospitals
state: Andhra Pradesh
city: Bengaluru
country: India
facility: MS Ramaiah
state: Karnataka
city: Kozhikode
country: India
facility: Government Medical College, Kozhikode
state: Kerala
city: Jaipur
country: India
facility: SMS Medical College & Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Diabetes, Thyroid and Endocrine Centre
state: Rajasthan
city: Hyderabad
country: India
facility: Diabetes Research Center, Hyderabad
state: Telangana
city: Hyderabad
country: India
facility: Nizams Institute of Medical Science
state: Telangana
city: L'Aquila
country: Italy
facility: Ospedale San Salvatore, Dipartimento Medico ASL1 Abruzzo, UOC Diabetologia
state: Abbruzzo
city: Chieti
country: Italy
facility: Università degli studi G. D'Annunzio Chieti Pescara - CAST
state: Abruzzo
city: Bologna
country: Italy
facility: A.O.U. Bologna_ Policlinico S.Orsola Malpighi
state: BO
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Milano
country: Italy
facility: Azienda Ospedaliera Luigi Sacco
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Koriyama-shi
country: Japan
facility: Seino Internal Medicine Clinic
state: Fukushima, Japan
city: Aichi
country: Japan
facility: TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
city: Ibaraki
country: Japan
facility: Naka Kinen Clinic
city: Kanagawa
country: Japan
facility: Fujisawa City Hospital_Kidney internal medicine
city: Kita-ku, Tokyo
country: Japan
facility: Higashijujo Sakai Diabetes Clinic_Internal Medicine
city: Saitama
country: Japan
facility: Koshigaya Municipal Hospital_Internal medicine
city: Saitama
country: Japan
facility: Hanyu General Hospital_Internal Medicine
city: Sendai-shi, Miyagi
country: Japan
facility: Shinden Higashi Clinic
city: Siga
country: Japan
facility: Omihachiman Community Medical Center_Nephrology
city: Tokyo
country: Japan
facility: Tokyo-Eki Center-building Clinic
city: Tokyo
country: Japan
facility: Fukuwa Clinic
city: Tokyo
country: Japan
facility: Kato Clinic of Internal Medicine
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Goyang
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
city: Gyeonggi-Do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hanyang University GURI Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Sarawak
country: Malaysia
facility: Hospital Miri
state: Miri
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun Ipoh
state: Perak
city: Sibu
country: Malaysia
facility: Hospital Sibu
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
city: Kota Bharu, Kelantan
country: Malaysia
facility: Hospital Universiti Sains Malaysia
city: Kuala Lumpur
country: Malaysia
facility: Prince Court Medical Centre
city: Melaka
country: Malaysia
facility: Hospital Melaka
city: Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang
city: Sungai Buloh
country: Malaysia
facility: Hospital Sungai Buloh
city: Włocławek
country: Poland
facility: Kardio Life
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Terpa Sp. z o.o. Sp. k.
state: Lubelskie Voivodeship
city: Rzeszow
country: Poland
facility: Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
state: Podkarpackie
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Katowice
country: Poland
facility: Uniwersyteckie Centrum Kliniczne SUM w Katowicach
city: Lublin
country: Poland
facility: Zanamed Medical Clinic Sp. z o.o.
city: Olsztyn
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Olsztynie
city: Szczecin
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie
city: Tczew
country: Poland
facility: Szpitale Tczewskie S.A.
city: Warszawa
country: Poland
facility: PANSTWOWY INSTYTUT MEDYCZNY MSWiA
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Łódź
country: Poland
facility: SP ZOZ Centralny Szpital Kliniczny Uniwerystetu Medycznego w Łodzi
city: Świecie
country: Poland
facility: Nowy Szpital Sp. z o.o.
city: Świecie
country: Poland
facility: Nowy Szpital Sp. z o.o.
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Córdoba
country: Spain
facility: Hospital Reina Sofia
city: Córdoba
country: Spain
facility: Hospital Reina Sofia
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
city: Madrid
country: Spain
facility: Fundacion Jiménez Díaz
city: Madrid
country: Spain
facility: Fundacion Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Sevilla
country: Spain
facility: Clínica Nuevas Tecnologías en Diabetes y Endocrinología
city: Sevilla
country: Spain
facility: Clínica Nuevas Tecnologías en Diabetes y Endocrinología
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi
state: Melikgazi
city: Adana
country: Turkey
facility: T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali
city: Ankara
country: Turkey
facility: Ankara Sehir Hastanesi Dahiliye Klinigi
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi
city: Kocaeli
country: Turkey
facility: Kocaeli University Nephrology Department
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: