AzTrials
AzTrials

Chronic Kidney DiseasePhase 2NCT06717698

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

A Phase 2 study testing NNC0519-0130 and Semaglutide in people with Chronic Kidney Disease, run by Novo Nordisk A/S at 147 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease
What is being tested?
NNC0519-0130 and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
465 participants
Where
147 sitesin 14 countries
Study dates
2 Dec 2024to 17 Sep 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

147 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

147 sites in 14 countries

Japan19 sites, 7 recruiting

  • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

    Aichi, 468-0009

    Active, not recruiting

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113

    Active, not recruiting

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113

    Recruiting

  • Fujisawa City Hospital_Kidney internal medicine

    Kanagawa, 251-8550

    Completed

  • Fujisawa City Hospital_Kidney internal medicine

    Kanagawa, 251-8550

    Recruiting

  • Higashijujo Sakai Diabetes Clinic_Internal Medicine

    Kita-ku, Tokyo, 114-0001

    Active, not recruiting

  • Seino Internal Medicine Clinic_Internal medicine

    Koriyama-shi, Fukushima, Fukushima, Japan, 963-8851

    Active, not recruiting

  • Koshigaya Municipal Hospital_Internal medicine

    Saitama, 343-8577

    Active, not recruiting

  • Hanyu General Hospital_Internal Medicine

    Saitama, 348-8505

    Completed

  • Shinden Higashi Clinic_Internal medicine

    Sendai-shi, Miyagi, 983-0039

    Active, not recruiting

  • Shinden Higashi Clinic

    Sendai-shi, Miyagi, 983-0039

    Recruiting

  • Omihachiman Community Medical Center_Nephrology

    Siga, 523-0082

    Active, not recruiting

  • Omihachiman Community Medical Center_Nephrology

    Siga, 523-0082

    Recruiting

  • Tokyo-Eki Center-building Clinic_Internal Medicine

    Tokyo, 103-0027

    Active, not recruiting

  • Fukuwa Clinic_Internal Medicine

    Tokyo, 104-0031

    Active, not recruiting

  • Fukuwa Clinic_Internal Medicine

    Tokyo, 104-0031

    Recruiting

  • Fukuwa Clinic

    Tokyo, 104-0031

    Recruiting

  • Kato Clinic of Internal Medicine_Internal Medicine

    Tokyo, 125-0054

    Active, not recruiting

  • Kato Clinic of Internal Medicine

    Tokyo, 125-0054

    Recruiting

Other trials in Japan

Poland19 sites, 9 recruiting

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

    Active, not recruiting

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

    Recruiting

  • Nowy Szpital Sp. z o.o.

    Gmina Świecie, 86-100

    Active, not recruiting

  • Nowy Szpital Sp. z o.o.

    Gmina Świecie, 86-100

    Not yet recruiting

  • Uniwersyteckie Centrum Kliniczne SUM w Katowicach

    Katowice, 40-752

    Completed

  • SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego UM w Lodzi

    Lodz, 90-153

    Not yet recruiting

  • SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

    Lodz, 92-213

    Active, not recruiting

  • Terpa Sp. z o.o. Sp. k.

    Lublin, Lubelskie Voivodeship, 20-333

    Active, not recruiting

  • Terpa Sp. z o.o. Sp. k.

    Lublin, 20-333

    Recruiting

  • Zanamed Medical Clinic Sp. z o.o.

    Lublin, 20-601

    Completed

  • Wojewodzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, 10-561

    Completed

  • Formed 2 Sp. z o.o.

    Oświęcim, 32-600

    Not yet recruiting

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

    Rzeszów, Podkarpackie Voivodeship, 35-301

    Not yet recruiting

  • Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie

    Szczecin, 70-111

    Not yet recruiting

  • Szpitale Tczewskie S.A.

    Tczew, 83-110

    Not yet recruiting

  • PANSTWOWY INSTYTUT MEDYCZNY MSWiA

    Warsaw, 02-507

    Active, not recruiting

  • Kardio Life - Tomasz Borkowski

    Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800

    Active, not recruiting

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

    Completed

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko

    Zabrze, 41-800

    Not yet recruiting

Other trials in Poland

United States18 sites

  • Albany Medical College

    Albany, New York, 12203

    Active, not recruiting

  • Rocky Mount Reg VA Med-DN

    Aurora, Colorado, 80045

    Completed

  • Davita Clinical Research

    El Paso, Texas, 79902

    Active, not recruiting

  • Northeast Research Institute

    Fleming Island, Florida, 32003

    Active, not recruiting

  • Elite Research Center

    Flint, Michigan, 48532

    Completed

  • Encore Medical Research LLC

    Hollywood, Florida, 33024

    Active, not recruiting

  • Clinical Research Consultants

    Kansas City, Missouri, 64111-5964

    Active, not recruiting

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

    Active, not recruiting

  • Northeast Research Institute

    Saint Augustine, Florida, 32080

    Active, not recruiting

  • Clinical Advancement Center

    San Antonio, Texas, 78212

    Active, not recruiting

  • Tekton Research

    San Antonio, Texas, 78251

    Completed

  • N America Res Inst - San Dimas

    San Dimas, California, 91773

    Active, not recruiting

  • NorCal Endocrinology and Internal Medicine

    San Ramon, California, 94583

    Active, not recruiting

  • Endeavor Health

    Skokie, Illinois, 60077

    Completed

  • Providence Medical Research Center

    Spokane, Washington, 99204

    Active, not recruiting

  • Velocity Clin. Res Valparaiso

    Valparaiso, Indiana, 46383

    Active, not recruiting

  • Brookview Hills Research Associates, LLC

    Winston-Salem, North Carolina, 27103

    Active, not recruiting

  • Clinical Research of Cent FL

    Winter Haven, Florida, 33880

    Completed

Other trials in United States

Turkey (Türkiye)14 sites, 6 recruiting

  • Adana Şehir Eğitim ve Araştırma Hastanesi

    Adana, 01060

    Active, not recruiting

  • Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali

    Ankara, 06230

    Recruiting

  • Hacettepe Üniversitesi Hastanesi- Nefroloji

    Ankara, 06230

    Completed

  • Ankara Bilkent Şehir Hastanesi-Dahiliye

    Ankara, 06800

    Active, not recruiting

  • Ankara Sehir Hastanesi Dahiliye Klinigi

    Ankara, 06800

    Recruiting

  • Gaziantep Universitesi Tip Fakultesi Hastanesi

    Gaziantep, 27070

    Recruiting

  • Gaziantep Üniversitesi Hastanesi- Endokrinoloji

    Gaziantep, 27070

    Active, not recruiting

  • Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye

    Istanbul, 34722

    Active, not recruiting

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

    Istanbul, 34722

    Recruiting

  • Ege Universitesi Hastanesi- Endokrinoloji

    Izmir, 35100

    Active, not recruiting

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100

    Recruiting

  • Erciyes Üniversitesi Hastanesi - Nefroloji

    Kayseri, Melikgazi, 38039

    Active, not recruiting

  • Kocaeli University Nephrology Department

    Kocaeli, 41380

    Recruiting

  • Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji

    Kocaeli, 41380

    Active, not recruiting

Other trials in Turkey (Türkiye)

Spain13 sites, 5 recruiting

  • Hospital Clinic i Provincial

    Barcelona, 08036

    Active, not recruiting

  • Hospital Reina Sofia

    Córdoba, 14004

    Active, not recruiting

  • Hospital Reina Sofia

    Córdoba, 14004

    Not yet recruiting

  • Hospital Universitario de Getafe

    Getafe, 28905

    Active, not recruiting

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907

    Active, not recruiting

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907

    Not yet recruiting

  • Fundacion Jiménez Díaz

    Madrid, 28040

    Active, not recruiting

  • Fundacion Jiménez Díaz

    Madrid, 28040

    Not yet recruiting

  • Hospital Clínico San Carlos

    Madrid, 28040

    Active, not recruiting

  • Clínica Nuevas Tecnologías en Diabetes y Endocrinología

    Seville, 41003

    Active, not recruiting

  • Clínica Nuevas Tecnologías en Diabetes y Endocrinología

    Seville, 41003

    Not yet recruiting

  • Hospital Universitario Doctor Peset

    Valencia, 46017

    Active, not recruiting

  • Hospital Universitario Doctor Peset

    Valencia, 46017

    Not yet recruiting

Other trials in Spain

Malaysia10 sites, 1 recruiting

  • Hospital Pulau Pinang

    George Town, Pulau Pinang, 10990

    Active, not recruiting

  • Hospital Raja Permaisuri Bainun Ipoh

    Ipoh, Perak, 30450

    Active, not recruiting

  • Hospital Universiti Sains Malaysia

    Kota Bharu, Kelantan, 16150

    Active, not recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

    Recruiting

  • Prince Court Medical Centre

    Kuala Lumpur, 50450

    Active, not recruiting

  • University Malaya Medical Centre

    Lembah Pantai, Kuala Lumpur, 59100

    Active, not recruiting

  • Hospital Melaka

    Malacca, 75400

    Active, not recruiting

  • Hospital Miri

    Miri, Sarawak, 98000

    Active, not recruiting

  • Hospital Sibu

    Sibu, Sarawak, 96000

    Active, not recruiting

  • Hospital Sungai Buloh

    Sungai Buloh, Selangor, 47000

    Active, not recruiting

Other trials in Malaysia

Bulgaria9 sites

  • SRH - Zdrave EAD

    Bankya, 1320

    Active, not recruiting

  • Medical centre Zdrave 1 OOD

    Kozloduy, 3320

    Active, not recruiting

  • Nader Yabrudi - ASMPVBE Individual practice

    Smolyan, 4700

    Active, not recruiting

  • Medical Centre Acad. Iv. Penchev EOOD

    Sofia, 1431

    Completed

  • Medical Centre Acad. Iv. Penchev EOOD

    Sofia, 1431

    Active, not recruiting

  • USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology

    Sofia, 1431

    Active, not recruiting

  • UMHAT Sofiamed EAD

    Sofia, 1750

    Active, not recruiting

  • UMHAT Sveta Anna Sofia AD, Second Clinic of Internal Diseases

    Sofia, 1750

    Active, not recruiting

  • UMHAT Sveta Marina EAD, Clinic of Internal Diseases

    Varna, 9010

    Active, not recruiting

Other trials in Bulgaria

Czechia8 sites

  • Nemocnice Český Krumlov, a.s.

    Český Krumlov, 381 01

    Withdrawn

  • MUDr. Petr Buček s.r.o.

    Frýdek-Místek, 738 01

    Withdrawn

  • CTC Hodonin s.r.o.

    Hodonín, 695 01

    Withdrawn

  • FNKV-Internal Clinic-Nephrology

    Prague, 100 34

    Withdrawn

  • DiaVize s.r.o.

    Prague, 140 00

    Withdrawn

  • IKEM Klinika nefrologie

    Prague, 140 21

    Withdrawn

  • Fledip s.r.o.

    Prague, 160 00

    Withdrawn

  • Internist Care s.r.o.

    Smiřice, 503 03

    Withdrawn

Other trials in Czechia

Italy8 sites, 1 recruiting

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

    Completed

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

    Bologna, BO, 40138

    Active, not recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25121

    Active, not recruiting

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

    Chieti, Abruzzo, 66100

    Active, not recruiting

  • ASL Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UOC Diabetologia

    L’Aquila, Abbruzzo, 67100

    Active, not recruiting

  • Azienda Ospedaliera Luigi Sacco

    Milan, 20157

    Active, not recruiting

  • Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello

    Pisa, 56124

    Not yet recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCS

    Roma, 00168

    Active, not recruiting

Other trials in Italy

India7 sites, 7 recruiting

  • MS Ramaiah

    Bengaluru, Karnataka, 560054

    Not yet recruiting

  • Endolife Specialty Hospitals

    Guntur, Andhra Pradesh, 522001

    Not yet recruiting

  • Diabetes Research Center, Hyderabad

    Hyderabad, Telangana, 500082

    Not yet recruiting

  • Nizams Institute of Medical Science

    Hyderabad, Telangana, 500082

    Not yet recruiting

  • SMS Medical College & Hospital

    Jaipur, Rajasthan, 302004

    Not yet recruiting

  • Diabetes, Thyroid and Endocrine Centre

    Jaipur, Rajasthan, 302006

    Not yet recruiting

  • Government Medical College, Kozhikode

    Kozhikode, Kerala, 673008

    Not yet recruiting

Other trials in India

Brazil6 sites

  • Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV

    Curitiba, Paraná, 80045-110

    Active, not recruiting

  • Instituto Pró-Renal Brasil

    Curitiba, Paraná, 80440-020

    Active, not recruiting

  • Centro de Diabetes Curitiba

    Curitiba, Paraná, 80810-040

    Active, not recruiting

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

    Active, not recruiting

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

    Porto Alegre, Rio Grande do Sul, 90430-001

    Active, not recruiting

  • Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos

    São Paulo, 04038-002

    Active, not recruiting

Other trials in Brazil

South Korea6 sites

  • Pusan National University Hospital

    Busan, 49241

    Active, not recruiting

  • National Health Insurance Corporation Ilsan Hospital

    Goyang-si, Gyeonggi-do, 10444

    Completed

  • Hallym UMC_Pyeongchon

    Gyeonggi-do, 14068

    Active, not recruiting

  • Hanyang University GURI Hospital

    Gyeonggi-do, 471-101

    Active, not recruiting

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul, 06591

    Completed

  • Korea University Guro Hospital

    Seoul, 08308

    Active, not recruiting

Other trials in South Korea

Argentina5 sites

  • Centro de Investigaciones Metabólicas

    City of Buenos Aires, C1056ABI

    Active, not recruiting

  • Instituto de Cardiología de Corrientes

    Corrientes, W3400AMY

    Active, not recruiting

  • Centro Médico CIMEL

    Lanús Este, Buenos Aires, B1824KAJ

    Active, not recruiting

  • Renalida

    Mar del Plata, Buenos Aires, B7600

    Active, not recruiting

  • Instituto de Investigaciones Clinicas Mar Del Plata

    Mar del Plata, B7600FZN

    Active, not recruiting

Other trials in Argentina

Australia5 sites, 1 recruiting

  • Castle Hill Medical Centre

    Castle Hill, New South Wales, 2154

    Active, not recruiting

  • Heart of Australia

    Chelmer, Queensland, 4068

    Active, not recruiting

  • Gosford Renal Research

    Gosford, New South Wales, 2250

    Active, not recruiting

  • Melbourne Renal Research Group

    Reservoir, Victoria, 3073

    Not yet recruiting

  • Sunshine Hospital - Western Centre for Health Research and Education

    St Albans, Victoria, 3021

    Active, not recruiting

Other trials in Australia

About this study

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

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.

Being tested
NNC0519-0130, Placebo, Semaglutide
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC0519-0130Drug

    NNC0519-0130 will be administered subcutaneously.

  • PlaceboDrug

    Placebo matching NNC0519-0130 will be administered subcutaneously.

  • SemaglutideDrug

    Semaglutide will be administered subcutaneously.

Study groups in NCT06717698
Study groupRoleWhat they receive
Dosing scheme a: NNC0519-0130ExperimentalParticipants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Receives: Drug: NNC0519-0130
Dosing scheme a: PlaceboPlacebo comparatorParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Receives: Drug: Placebo
Dosing scheme b: NNC0519-0130ExperimentalParticipants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Receives: Drug: NNC0519-0130
Dosing scheme b: PlaceboPlacebo comparatorParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Receives: Drug: Placebo
Dosing scheme c: NNC0519-0130ExperimentalParticipants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Receives: Drug: NNC0519-0130
Dosing scheme c: PlaceboPlacebo comparatorParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Receives: Drug: Placebo
Dosing scheme d: NNC0519-0130ExperimentalParticipants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
Receives: Drug: NNC0519-0130
Dosing scheme d: PlaceboPlacebo comparatorParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Receives: Drug: Placebo
Dosing scheme e: SemaglutideActive comparatorParticipants will receive once-weekly s.c injections of semaglutide with a dose escalation done until maintenance dose is reached.
Receives: Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in urinary albumin-to-creatinine ratio (UACR) at week 12

    Measured as a ratio to baseline.

    Measured: From baseline (week 0) to end of a given maintenance dose period (week 12)

  2. Change in urinary albumin-to-creatinine ratio (UACR) at week 24

    Measured as a ratio to baseline.

    Measured: From baseline (week 0) to end of a given maintenance dose period (week 24)

  3. Change in urinary albumin-to-creatinine ratio (UACR) at week 36

    Measured as a ratio to baseline.

    Measured: From baseline (week 0) to end of a given maintenance dose period (week 36)

Secondary outcomes (10)

  1. Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021)

    Measured in mililitre per minute per 1.73 square metre (mL/min/1.73 m^2).

    Measured: From baseline (week 0) to end of treatment (week 36)

  2. Change in estimated glomerular filtration rate (eGFR) (creatinine-based CKD-EPI 2021)

    Measured in mililitre per minute per 1.73 square metre (mL/min/1.73 m^2).

    Measured: From baseline (week 0) to end of treatment (week 36)

  3. Relative change in body weight

    Measured in percentage (%).

    Measured: From baseline (week 0) to end of treatment (week 36)

  4. Achievement of greater than or equal to (≥) 5 percentage (%) weight reduction

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 36)

  5. Achievement of greater than or equal to (≥) 10 percentage (%) weight reduction

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 36)

  6. Change in waist circumference

    Measured in centimetres (cm).

    Measured: From baseline (week 0) to end of treatment (week 36)

  7. Change in glycated haemoglobin (HbA1c)

    Measured in percentage point (%-point).

    Measured: From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)

  8. Change in systolic blood pressure

    Measured in millimetres of mercury (mmHg).

    Measured: From baseline (week 0) to end of treatment (week 36)

  9. Change in diastolic blood pressure

    Measured in millimetres of mercury (mmHg).

    Measured: From baseline (week 0) to end of treatment (week 36)

  10. Number of treatment emergent adverse events (TEAEs)

    Measured as count of events.

    Measured: From baseline (week 0) to end of study (week 40)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2024
  2. Study start2 Dec 2024
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion17 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
465 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06717698
Sponsor's protocol ID
NN9541-7841
Other IDs
U1111-1302-5591, 2024-510846-15
Status last verified
Mar 2026
First submitted
30 Nov 2024
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NNC0519-0130 and Semaglutide in people with Chronic Kidney Disease, run by Novo Nordisk A/S at 147 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in Japan, Poland, United States, Turkey (Türkiye), Spain and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in urinary albumin-to-creatinine ratio (UACR) at week 12 (time frame: From baseline (week 0) to end of a given maintenance dose period (week 12)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06717698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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