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NNC0519-0130

Phase 2

Chronic Kidney Disease | Small molecule | Nephrology |Novo Nordisk A/S|Trials Updated: Sep 21, 2026

NNC0519-0130 development status

Highest phase Phase 2
Registered trials 10 across 1 sponsor since May 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials10
Total Enrollment1,620

FDA Designations

No designations recorded

NNC0519-0130 clinical trials

NNC0519-0130 · 10 trials · 4 indications

Phase 2 3Phase 1 7
NCT06717698A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney DiseaseChronic Kidney Disease
RECRUITING465 Analytics
NCT06326047A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED299 Analytics
NCT06326060A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose WeightObesity
COMPLETED354 Analytics
PHASE2RECRUITING
A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease
Chronic Kidney Disease
NCT06717698465
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PHASE2COMPLETED
A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes
Diabetes Mellitus, Type 2
NCT06326047299
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PHASE2COMPLETED
A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight
Obesity
NCT06326060354
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Study Endpoints

Primary Endpoints

Change in urinary albumin-to-creatinine ratio (UACR) at week 12
From baseline (week 0) to end of a given maintenance dose period (week 12)

Measured as a ratio to baseline.

Change in urinary albumin-to-creatinine ratio (UACR) at week 24
From baseline (week 0) to end of a given maintenance dose period (week 24)

Measured as a ratio to baseline.

Change in urinary albumin-to-creatinine ratio (UACR) at week 36
From baseline (week 0) to end of a given maintenance dose period (week 36)

Measured as a ratio to baseline.

Change in Glycated haemoglobin (HbA1c)
From baseline (week 0) to 12 weeks on a given maintenance dose

Measured as percentage point (%-point)

Relative change in body weight
From baseline (week 0) to end of treatment (week 36)

Measured in percentage of body weight.

AUC, NNC0519-0130, SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period
From pre-dose up to 7 days post-dose

Measured in hours\*nanomoles per liter (h\*nmol/L).

Number of Adverse Events (AEs)
From randomisation (week 0) to week 18

Measured as number of events.

Number of adverse events
From time of first dosing (day 1) until completion of the end of study visit (day 274/253)

Measured in number of events.

Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state
Day 8

Measured in hours picograms per milliliter (h\*pg/mL).

Area under the levonorgestrel plasma concentration time curve during a dosing interval at steady state
Day 8

Measured in h\*pg/mL.

Area under the levonorgestrel plasma concentration time curveduring a dosing interval at steady state
Day 188

Measured in h\*pg/mL.

Area under the curve (AUC)0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment
From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)

Measured in hours\* nanomoles per litre (h\*nmol/L).

AUC0-24h,0130, SS: Area Under the NNC0519-0130 Plasma Concentration-Time Curve After the Last Dose in Each Treatment Period
From pre-dose until 24 hours post-dose relative to last dose in each treatment period

Measured in h\*nmol/L.

Number of treatment emergent adverse events (TEAE) in single ascending dose (SAD) part
From time of dosing (day 1) until completion of the follow-up visit (assessed up to 22 days)

Measured as Number of events

Number of treatment emergent adverse events (TEAE) in the Multiple ascending dose with daily dosing (MAD QD) subcutaneous cohort
From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)

Measured as Number of events

Number of treatment emergent adverse events (TEAE) in MAD QW s.c. cohort
From time of first dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)

Measured as Number of events

Number of treatment emergent adverse events (TEAE) in T2D QW cohort
From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)

Measured as number of events

Secondary Endpoints

Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021)
From baseline (week 0) to end of treatment (week 36)
Change in estimated glomerular filtration rate (eGFR) (creatinine-based CKD-EPI 2021)
From baseline (week 0) to end of treatment (week 36)
Relative change in body weight
From baseline (week 0) to end of treatment (week 36)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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.
Dosing scheme a: PlaceboPLACEBO_COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly.
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.
Dosing scheme b: PlaceboPLACEBO_COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly.
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.
Dosing scheme c: PlaceboPLACEBO_COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly.
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.
Dosing scheme d: PlaceboPLACEBO_COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly.
Dosing scheme e: SemaglutideACTIVE_COMPARATORParticipants will receive once-weekly s.c injections of semaglutide with a dose escalation done until maintenance dose is reached.
Dosing scheme A (NNC0519-0130)EXPERIMENTALParticipants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as subcutaneous (s.c.) injection in dose escalating manner.
Dosing scheme A (Placebo)PLACEBO_COMPARATORParticipants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Dosing scheme B (NNC0519-0130)EXPERIMENTALParticipants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as s.c. injection in dose escalating manner.
Dosing scheme B (Placebo)PLACEBO_COMPARATORParticipants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Dosing scheme C (NNC0519-0130)EXPERIMENTALParticipants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.
Dosing scheme C (Placebo)PLACEBO_COMPARATORParticipants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Dosing scheme D (NNC0519-0130)EXPERIMENTALParticipants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.
Dosing scheme D (Placebo)PLACEBO_COMPARATORParticipants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Dosing scheme E (NNC0519-0130)EXPERIMENTALParticipants will receive NNC0519-0130 at 7 dose levels once weekly as s.c. injection in dose escalating manner.
Dosing scheme E (Placebo)PLACEBO_COMPARATORParticipants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Dosing scheme F (tirzepatide)ACTIVE_COMPARATORParticipants will receive tirzepatide at 6 dose levels once weekly as s.c. injection in dose escalating manner.
Dosing scheme e: NNC0519-0130EXPERIMENTALParticipants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks.
Dosing scheme e: PlaceboPLACEBO_COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Dosing scheme f: NNC0519-0130EXPERIMENTALParticipants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks.
Dosing scheme f: PlaceboPLACEBO_COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Dosing scheme g: TirzepatideACTIVE_COMPARATORParticipants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks.
NNC0519-0130EXPERIMENTALParticipants will receive once weekly subcutaneous (s.c.) administration of NNC0519-0130 in dose escalation manner.
PlaceboPLACEBO_COMPARATORParticipants will receive once weekly subcutaneous administration of placebo matched to NNC0519-0130.
Arm 1: NNC0519-0130EXPERIMENTALParticipants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a predetermined dose escalation regimen 1 in the main and extension phase.
Arm 2: NNC0519-0130EXPERIMENTALParticipants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 2 in the main phase and extension phase.
Arm 3: NNC0519-0130EXPERIMENTALParticipants will receive twice-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 3 in the main phase and extension phase.
Arm 4: NNC0519-0130EXPERIMENTALParticipants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 4 in the main and extension phase.
NNC0519-0130 + OC+ paracetamolEXPERIMENTALAll participants will initiate treatment with paracetamol (once) and oral contraceptive (Levonorgestrel + Ethinylestradiol) treatment only followed by a period with NNC0519-0130 treatment only, thereafter a period with NNC0519-0130, paracetamol (once) and oral contraceptive treatment.
Single ascending dose (SAD) partEXPERIMENTALParticipants will receive up to six dose levels of subcutaneous NNC0519-0130 or matching placebo in a sequential manner with the dose increasing between cohorts.
Multiple ascending dose (MAD) QD partEXPERIMENTALMAD QD part comprises two cohorts in participants with overweight or obesity and a cohort in participants with type 2 diabetes (T2D). The participants in first cohort will receive NNC0519-0130 or matching placebo subcutaneously up to 5 dose levels, and the participants in the second MAD QD cohort will receive NNC0519-0130 or matching placebo orally up to 5 dose levels.
Type 2 diabetes (T2D) partEXPERIMENTALParticipants will receive NNC0519-0130 or matching placebo up to 2 dose levels with dose escalation within the cohort.
MAD QW partEXPERIMENTALMAD QW part comprises two cohorts in participants with overweight or obesity and who are otherwise generally healthy. The participants in first cohort will receive NNC0519-0130 and 2nd cohort will receive matching placebo subcutaneously up to 6 dose levels.

Interventions

NameTypeDescription
NNC0519-0130DRUGNNC0519-0130 will be administered subcutaneously.
PlaceboDRUGPlacebo matching NNC0519-0130 will be administered subcutaneously.
SemaglutideDRUGSemaglutide will be administered subcutaneously.
TrizepatideDRUGTrizepatide will be administered subcutaneously.
TirzepatideDRUGTirzepatide will be administered subcutaneously.
Levonorgestrel + EthinylestradiolDRUGLevonorgestrel + Ethinylestradiol will be administered orally.
ParacetamolDRUGParacetamol will be administered orally.
Placebo (NNC0519-0130)DRUGSAD part: Participants will receive up to six dose levels of subcutaneous placebo (NNC0519-0130) in a sequential manner with the dose increasing between cohorts. MAD part: Participants in first cohort will receive placebo (NNC0519-0130) subcutaneously up to 5 dose levels, and the participants in the second MAD cohort will receive NNC0519-0130 orally up to 4 dose levels. T2D part: Participants will receive placebo (NNC0519-0130) up to two dose levels with dose escalation within the cohort. MAD QW part: Participants will receive Placebo up to 6 dose levels.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites147

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 stu...

Countries:United StatesArgentinaAustraliaBrazilBulgariaCzechiaIndiaItalyJapanMalaysiaPolandSouth KoreaSpainTurkey (Türkiye)CanadaSouth AfricaChinaAustriaGermanyDenmark
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Competitive Landscape -Chronic Kidney Disease 139 trials

Top 20 of 28 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN14PHASE3Savolitinib, Baxdrostat, Zibotentan/Dapagliflozin, Dapagliflozin, Balcinrenone
Eli Lilly and CompanyLLY5PHASE3Retatrutide, Orforglipron, Clazakizumab, LY3841136, SGLT2 inhibitor
Novo Nordisk A/S Sponsored ADR Class BNVO7PHASE3DCR-PHXC, NNC0519-0130, Semaglutide, NNC0537-1482
Novartis AG Sponsored ADRNVS5PHASE3Zigakibart, OJR520
Amgen Inc.AMGN1PHASE3Etelcalcetide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK2PHASE3Mezagitamab
ProKidney Corp. Class APROK3PHASE3Rilparencel
Humacyte, Inc.HUMA1PHASE3Symvess
Fresenius Medical Care AG Sponsored ADRFMS7PHASE2Difelikefalin
BayerBAYRY8PHASE3Finerenone, Nurandociguat
Regeneron Pharmaceuticals, Inc.REGN3PHASE1Vonsetamig, REGN9933, REGN7508, REGN9533
GSK plc Sponsored ADRGSK2PHASE1GSK4771261
Sanofi SA Sponsored ADRSNY2PHASE1rilzabrutinib
United Therapeutics CorporationUTHR2PHASE110 GE Xenokidney, GGTA1 KO Thymokidney
Pfizer Inc.PFE1PHASE1PF-07328948
OPKO Health, Inc.OPK1PHASE2CTAP101
Incyte CorporationINCY2PHASE1INCB161734, INCB123667
Bristol-Myers Squibb CompanyBMY1PHASE1Golcadomide
Merck & Co., Inc.MRK1PHASE1Nemtabrutinib
Kailera Therapeutics, Inc.KLRA1PHASE1Ribupatide (KAI-9531)
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Recent Changes (Last 90 Days)

MEDIUMSep 13, 2026NCT06326047TRIAL_REMOVED: changed
MEDIUMSep 13, 2026NCT06326047TRIAL_REMOVED: changed

Frequently asked questions about NNC0519-0130

What is NNC0519-0130?

NNC0519-0130 is an investigational small molecule medicine being developed by Novo Nordisk A/S. It is being studied in chronic kidney disease, type 2 diabetes, and obesity. It is not yet approved and remains in clinical development, with Phase 2 testing underway in chronic kidney disease.

What is NNC0519-0130 used for?

NNC0519-0130 is being studied for chronic kidney disease, type 2 diabetes, and obesity. The most advanced testing is a Phase 2 study in chronic kidney disease that measures whether different doses can reduce kidney damage. Earlier Phase 1 studies in people with excess body weight, with or without type 2 diabetes, have been completed.

Who makes NNC0519-0130?

NNC0519-0130 is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical program, which includes seven trials in total across chronic kidney disease, type 2 diabetes, and obesity.

What phase is NNC0519-0130 in?

NNC0519-0130 is in Phase 2 development. The Phase 2 trial is a randomized, double-blind, placebo-controlled study in chronic kidney disease and is currently recruiting. The remaining completed studies in the program were Phase 1 trials in obesity and in type 2 diabetes with obesity.

What clinical trials is NNC0519-0130 in?

The active trial is NCT06717698, a Phase 2 randomized, double-blind, placebo-controlled study of different doses of NNC0519-0130 in chronic kidney disease, enrolling 465 participants across the United States, Argentina, Australia, Brazil, Bulgaria, Czechia, India, Italy, Japan, Malaysia, Poland, South Korea, Spain, and Turkey. Completed Phase 1 trials include NCT07004322, NCT06718998, and NCT06567041.

How many people have been enrolled in NNC0519-0130 trials?

Across the clinical program, 667 participants have been enrolled in NNC0519-0130 trials. The largest is the ongoing Phase 2 chronic kidney disease study NCT06717698 with 465 participants. Completed Phase 1 studies enrolled 20 participants in China, 134 in Austria, and 82 in Germany.

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