NCT06717698RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 11 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 465 (estimated)
- First submitted
- 30 Nov 2024
- Start date
- 2 Dec 2024
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Chronic kidney disease, Obesity, Type 2 diabetes
- NCT number
- NCT06717698
- EU CT number
- 2024-510846-15-00
- EudraCT number
- 2024-510846-15
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 465
- From 2 Dec 2024 to the primary completion date, 1 Sept 2026
- 133 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (133)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Investigaciones Metabólicas Coordinator of this site? Confirm its status | City of Buenos Aires | Argentina | Active, not recruiting |
| Instituto de Cardiologia de Corrientes Coordinator of this site? Confirm its status | Corrientes | Argentina | Active, not recruiting |
| Centro Médico CIMEL Coordinator of this site? Confirm its status | Lanús Este | Argentina | Active, not recruiting |
| Instituto de Investigaciones Clinicas Mar del Plata Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Active, not recruiting |
| Renalida Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Active, not recruiting |
| Castle Hill Medical Centre Coordinator of this site? Confirm its status | Castle Hill | Australia | Active, not recruiting |
| Heart of Australia Coordinator of this site? Confirm its status | Chelmer | Australia | Active, not recruiting |
| Gosford Renal Research Coordinator of this site? Confirm its status | Gosford | Australia | Active, not recruiting |
| Melbourne Renal Research Group Coordinator of this site? Confirm its status | Reservoir | Australia | Not yet recruiting |
| Sunshine Hospital - Western Centre for Health Research and Education Coordinator of this site? Confirm its status | St Albans | Australia | Active, not recruiting |
| Specialized Hospital For Rehabilitation Health EAD Coordinator of this site? Confirm its status | Bankya | Bulgaria | Completed |
| Medical Center Zdrave-1 OOD Coordinator of this site? Confirm its status | Kozloduy | Bulgaria | Completed |
| Dr. Nader Yabrudi Outpatient Clinic For Specialized Medical Assistance In Internal Diseases And Endocrinology Individual Practice EOOD Coordinator of this site? Confirm its status | Smolyan | Bulgaria | Completed |
| Medical Center Akad. Iv. Penchev EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| University Hospital St. Anna Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| University Multiprofile Hospital For Active Treatment Sofiamed OOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| MBAL Sveta Marina EAD Coordinator of this site? Confirm its status | Varna | Bulgaria | Completed |
| Instituto Pro Renal Brasil Coordinator of this site? Confirm its status | Curitiba | Brazil | Active, not recruiting |
| Centro de Diabetes Curitiba Coordinator of this site? Confirm its status | Curitiba | Brazil | Active, not recruiting |
| Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV Coordinator of this site? Confirm its status | Curitiba | Brazil | Active, not recruiting |
| Irmandade Da Santa Casa de Misericordia de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Active, not recruiting |
| Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda. Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Active, not recruiting |
| Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos Coordinator of this site? Confirm its status | São Paulo | Brazil | Active, not recruiting |
| Nemocnice Český Krumlov, a.s. Coordinator of this site? Confirm its status | Český Krumlov | Czechia | Withdrawn |
| MUDr. Petr Buček s.r.o. Coordinator of this site? Confirm its status | Frýdek-Místek | Czechia | Withdrawn |
| CTC Hodonin s.r.o. Coordinator of this site? Confirm its status | Hodonín | Czechia | Withdrawn |
| IKEM Klinika nefrologie Coordinator of this site? Confirm its status | Prague | Czechia | Withdrawn |
| FNKV-Internal Clinic-Nephrology Coordinator of this site? Confirm its status | Prague | Czechia | Withdrawn |
| DiaVize s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Withdrawn |
| Fledip s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Withdrawn |
| Internist Care s.r.o Coordinator of this site? Confirm its status | Smiřice | Czechia | Withdrawn |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Completed |
| Hospital Universitario de Getafe Coordinator of this site? Confirm its status | Getafe | Spain | Completed |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Universitario Doctor Peset Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| MS Ramaiah Coordinator of this site? Confirm its status | Bengaluru | India | Not yet recruiting |
| Endolife Specialty Hospitals Coordinator of this site? Confirm its status | Guntur | India | Not yet recruiting |
| Nizams Institute of Medical Science Coordinator of this site? Confirm its status | Hyderabad | India | Not yet recruiting |
| Diabetes Research Center, Hyderabad Coordinator of this site? Confirm its status | Hyderabad | India | Not yet recruiting |
| Diabetes, Thyroid and Endocrine Centre Coordinator of this site? Confirm its status | Jaipur | India | Not yet recruiting |
| SMS Medical College & Hospital Coordinator of this site? Confirm its status | Jaipur | India | Not yet recruiting |
| Government Medical College, Kozhikode Coordinator of this site? Confirm its status | Kozhikode | India | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Completed |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Completed |
| Universita' Degli Studi G. D'Annunzio Di Chieti Coordinator of this site? Confirm its status | Chieti Scalo | Italy | Completed |
| Azienda Sanitaria Locale Avezzano Sulmona L'Aquila Coordinator of this site? Confirm its status | L'aquila | Italy | Completed |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology Coordinator of this site? Confirm its status | Aichi | Japan | Active, not recruiting |
| Naka Kinen Clinic_Internal medicine Coordinator of this site? Confirm its status | Ibaraki | Japan | Active, not recruiting |
| Fujisawa City Hospital_Kidney internal medicine Coordinator of this site? Confirm its status | Kanagawa | Japan | Completed |
| Higashijujo Sakai Diabetes Clinic_Internal Medicine Coordinator of this site? Confirm its status | Kita-ku, Tokyo | Japan | Active, not recruiting |
| Seino Internal Medicine Clinic_Internal medicine Coordinator of this site? Confirm its status | Koriyama-shi, Fukushima | Japan | Active, not recruiting |
| Koshigaya Municipal Hospital_Internal medicine Coordinator of this site? Confirm its status | Saitama | Japan | Active, not recruiting |
| Hanyu General Hospital_Internal Medicine Coordinator of this site? Confirm its status | Saitama | Japan | Completed |
| Shinden Higashi Clinic Coordinator of this site? Confirm its status | Sendai-shi, Miyagi | Japan | Recruiting |
| Shinden Higashi Clinic_Internal medicine Coordinator of this site? Confirm its status | Sendai-shi, Miyagi | Japan | Active, not recruiting |
| Omihachiman Community Medical Center_Nephrology Coordinator of this site? Confirm its status | Siga | Japan | Active, not recruiting |
| Kato Clinic of Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Fukuwa Clinic Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Kato Clinic of Internal Medicine_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Active, not recruiting |
| Fukuwa Clinic_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Active, not recruiting |
| Tokyo-Eki Center-building Clinic_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Active, not recruiting |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Active, not recruiting |
| National Health Insurance Corporation Ilsan Hospital Coordinator of this site? Confirm its status | Goyang-si | South Korea | Completed |
| Hallym UMC_Pyeongchon Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Active, not recruiting |
| Hanyang University Guri Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Active, not recruiting |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Active, not recruiting |
| Hospital Pulau Pinang Coordinator of this site? Confirm its status | George Town | Malaysia | Active, not recruiting |
| Hospital Raja Permaisuri Bainun Ipoh Coordinator of this site? Confirm its status | Ipoh | Malaysia | Active, not recruiting |
| Hospital Universiti Sains Malaysia Coordinator of this site? Confirm its status | Kota Bharu, Kelantan | Malaysia | Active, not recruiting |
| Prince Court Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Active, not recruiting |
| University Malaya Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Recruiting |
| University Malaya Medical Centre Coordinator of this site? Confirm its status | Lembah Pantai | Malaysia | Active, not recruiting |
| Hospital Melaka Coordinator of this site? Confirm its status | Malacca | Malaysia | Active, not recruiting |
| Hospital Miri Coordinator of this site? Confirm its status | Miri | Malaysia | Active, not recruiting |
| Hospital Sibu Coordinator of this site? Confirm its status | Sibu | Malaysia | Active, not recruiting |
| Hospital Sungai Buloh Coordinator of this site? Confirm its status | Sungai Buloh | Malaysia | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Zanamed Medical Clinic Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Terpa Sp. z o.o. Sp. k. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Formed 2 Sp. z o.o. Coordinator of this site? Confirm its status | Oswiecim | Poland | Completed |
| Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w Rzeszowie Coordinator of this site? Confirm its status | Rzeszów | Poland | Completed |
| Nowy Szpital Sp. z o.o. Coordinator of this site? Confirm its status | Swiecie | Poland | Completed |
| Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie Coordinator of this site? Confirm its status | Szczecin | Poland | Completed |
| Szpitale Tczewskie S.A. Coordinator of this site? Confirm its status | Tczew | Poland | Completed |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Kardio Life Coordinator of this site? Confirm its status | Włocławek | Poland | Completed |
| Centrum Medyczne Oporow Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Zabrze | Poland | Completed |
| Albany Medical College Coordinator of this site? Confirm its status | Albany | United States | Active, not recruiting |
| Rocky Mount Reg VA Med-DN Coordinator of this site? Confirm its status | Aurora | United States | Completed |
| Davita Clinical Research Coordinator of this site? Confirm its status | El Paso | United States | Active, not recruiting |
| Northeast Research Institute Coordinator of this site? Confirm its status | Fleming Island | United States | Active, not recruiting |
| Elite Research Center Coordinator of this site? Confirm its status | Flint | United States | Completed |
| Encore Medical Research LLC Coordinator of this site? Confirm its status | Hollywood | United States | Active, not recruiting |
| Clinical Research Consultants Coordinator of this site? Confirm its status | Kansas City | United States | Active, not recruiting |
| Carteret Medical Group Coordinator of this site? Confirm its status | Morehead City | United States | Active, not recruiting |
| Northeast Research Institute Coordinator of this site? Confirm its status | Saint Augustine | United States | Active, not recruiting |
| Tekton Research Coordinator of this site? Confirm its status | San Antonio | United States | Completed |
| Clinical Advancement Center Coordinator of this site? Confirm its status | San Antonio | United States | Active, not recruiting |
| N America Res Inst - San Dimas Coordinator of this site? Confirm its status | San Dimas | United States | Active, not recruiting |
| NorCal Endocrinology and Internal Medicine Coordinator of this site? Confirm its status | San Ramon | United States | Active, not recruiting |
| Endeavor Health Coordinator of this site? Confirm its status | Skokie | United States | Completed |
| Providence Medical Research Center Coordinator of this site? Confirm its status | Spokane | United States | Active, not recruiting |
| Velocity Clin. Res Valparaiso Coordinator of this site? Confirm its status | Valparaiso | United States | Active, not recruiting |
| Brookview Hills Research Associates, LLC Coordinator of this site? Confirm its status | Winston-Salem | United States | Active, not recruiting |
| Clinical Research of Cent FL Coordinator of this site? Confirm its status | Winter Haven | United States | Completed |
| Adana Şehir Eğitim ve Araştırma Hastanesi Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Active, not recruiting |
| Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Hacettepe Üniversitesi Hastanesi- Nefroloji Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Completed |
| Ankara Bilkent Şehir Hastanesi-Dahiliye Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Active, not recruiting |
| Ankara Sehir Hastanesi Dahiliye Klinigi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Gaziantep Universitesi Tip Fakultesi Hastanesi Coordinator of this site? Confirm its status | Gaziantep | Turkey (Türkiye) | Recruiting |
| Gaziantep Üniversitesi Hastanesi- Endokrinoloji Coordinator of this site? Confirm its status | Gaziantep | Turkey (Türkiye) | Active, not recruiting |
| Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Active, not recruiting |
| T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Ege Universitesi Hastanesi- Endokrinoloji Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Active, not recruiting |
| Ege Universitesi Tip Fakultesi Hastanesi Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Recruiting |
| Erciyes Üniversitesi Hastanesi - Nefroloji Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Active, not recruiting |
| Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Active, not recruiting |
| Kocaeli University Nephrology Department Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.