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NNC0519-0130

Phase 2

Chronic Kidney Disease | Small molecule | Nephrology |Novo Nordisk A/S|Last Updated: Aug 13, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment465

FDA Designations

No designations recorded

Clinical trial landscape

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 89 trials

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN12PHASE3Savolitinib, Sunitinib
Eli Lilly and CompanyLLY5PHASE3Retatrutide
Fresenius Medical Care AG Sponsored ADRFMS8PHASE3Dialysis
Novartis AG Sponsored ADRNVS4PHASE3zigakibart
Novo Nordisk A/S Sponsored ADR Class BNVO3PHASE3DCR-PHXC
Amgen Inc.AMGN1PHASE3Etelcalcetide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK2PHASE3Mezagitamab
ProKidney Corp. Class APROK3PHASE3Renal Autologous Cell Therapy
Humacyte, Inc.HUMA1PHASE3Acellular Tissue Engineered Vessel
DexCom, Inc.DXCM1PHASE3Sotagliflozin
GSK plc Sponsored ADRGSK1PHASE1GSK4771261
Regeneron Pharmaceuticals, Inc.REGN2PHASE1Vonsetamig
Merck & Co., Inc.MRK1PHASE1MK-2828
United Therapeutics CorporationUTHR2PHASE110 GE Xenokidney
Pfizer Inc.PFE1PHASE1PF-07328948
OPKO Health, Inc.OPK1PHASE2CTAP101
Medtronic PlcMDT2 - Undisclosed
Incyte CorporationINCY1PHASE1INCB123667
Merit Medical Systems, Inc.MMSI1 - Undisclosed
Sanofi SA Sponsored ADRSNY1 - Undisclosed
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Frequently asked questions about NNC0519-0130

What is NNC0519-0130 used for?

NNC0519-0130 is an investigational small molecule being studied for type 2 diabetes, obesity, and chronic kidney disease. It is in Phase 2 clinical development for obesity and chronic kidney disease, and has also been studied in healthy volunteers and people with type 2 diabetes.

Who makes NNC0519-0130?

NNC0519-0130 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials of this investigational medicine across multiple countries.

What phase is NNC0519-0130 in?

NNC0519-0130 is currently in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials for obesity and type 2 diabetes, and an ongoing Phase 2 trial is recruiting participants with chronic kidney disease.

What clinical trials is NNC0519-0130 in?

NNC0519-0130 has been studied in several clinical trials, including NCT05363774 (Phase 1 in healthy volunteers and type 2 diabetes), NCT06326060 (Phase 2 in obesity), NCT06717698 (Phase 2 in chronic kidney disease, currently recruiting), and NCT06718998 (Phase 1 in obesity).

Is NNC0519-0130 FDA approved?

NNC0519-0130 is not FDA approved. It is an investigational drug currently in clinical development, with ongoing Phase 2 trials. No approval status has been reported, and it remains under study for safety and efficacy.

What does NNC0519-0130 target?

The specific molecular target of NNC0519-0130 has not been disclosed in available information. It is described as a small molecule being studied for metabolic and kidney conditions, but its mechanism of action is not publicly detailed.