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NNC0519-0130

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Apr 7, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials6
Total Enrollment506
FDA Designations
No designations recorded
Clinical Trials (6)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06326047A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 DiabetesPHASE2 COMPLETED 299 — — Mar 18, 2024Oct 13, 2025Dec 31, 202594 United States, Australia +5
NCT07004322A Research Study of the New Medicine NNC0519-0130 in Male Chinese Participants Living With Excess Body WeightPHASE1 COMPLETED 20 — — May 26, 2025Jan 28, 2026Mar 31, 20261 China
NCT06567041A Research Study of How Safe a New Medicine Called NNC0519 0130 is and to Test Its Effect in People Living With Excess Body Weight With or Without Type 2 DiabetesPHASE1 COMPLETED 82 — — Aug 7, 2024Dec 10, 2025Dec 31, 20251 Germany
NCT06513104A Research Study Looking Into the Effect of NNC0519-0130 on Blood Levels of a Birth Control Pill and Emptying of the Stomach in Women After MenopausePHASE1 COMPLETED 47 — — Jul 18, 2024Sep 30, 2025Mar 12, 20261 Germany
NCT06370819A Research Study Looking Into Blood Levels of the Medicine NNC0519-0130 in the Body in Participants With Normal or Reduced Kidney FunctionPHASE1 COMPLETED 36 — — Apr 15, 2024Nov 27, 2024Apr 7, 20261 Germany
NCT05870670A Research Study of a New Medicine NNC0519-0130 in Japanese and Non-Japanese MenPHASE1 COMPLETED 22 — — May 15, 2023Oct 16, 2023Jun 18, 20251 Japan
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Study Endpoints
Primary Endpoints
Change in Glycated haemoglobin (HbA1c)
From baseline (week 0) to 12 weeks on a given maintenance dose

Measured as percentage point (%-point)

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
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.

Secondary Endpoints
Change in Glycated haemoglobin (HbA1c)
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)
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 (NNC0519-0130)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.
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.
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.
Interventions
NameTypeDescription
NNC0519-0130DRUGNNC0519-0130 will be administered subcutaneously.
PlaceboDRUGPlacebo will be administered subcutaneously.
TrizepatideDRUGTrizepatide will be administered subcutaneously.
Levonorgestrel + EthinylestradiolDRUGLevonorgestrel + Ethinylestradiol will be administered orally.
ParacetamolDRUGParacetamol will be administered orally.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites94

Inclusion Criteria: * Female of non-childbearing potential, or male. * For United States (US) only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency and willingness to continue using it through-out the study or male. * Age 18-75 ...

Countries:United StatesAustraliaCanadaIndiaJapanSouth AfricaSouth KoreaChinaGermany
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07004322TRIAL_REMOVED: changed
LOWMay 24, 2026NCT07004322studyFirstPostDate: changed
MEDIUMMay 21, 2026NCT06513104TRIAL_REMOVED: changed
MEDIUMMay 21, 2026NCT06513104TRIAL_REMOVED: changed