Recent Updates
Recently added Catalysts

NNC0519-0130 B

Phase 1

Obesity | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Nov 25, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06642571A Research Study to Compare How Much of the Medicine NNC0519-0130 is in the Blood of People With Overweight or Obesity Who Receive 2 Preparations of the MedicinePHASE1 COMPLETED 46Oct 15, 2024May 31, 2025Nov 25, 20251 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
AUC,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve during a dosing interval at steady state (SS)
From pre-dose up to 7 days post-dose

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

Secondary Endpoints
Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 at steady state
From pre-dose up to 7 days post-dose
Number of adverse events
From time of first dosing (day 1) until completion of the end of study visit (day 141/162)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1a: NNC0519-0130 C and NNC0519-0130 BEXPERIMENTALParticipants will start treatment with formulation NNC0519-0130 C and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C.
Part 1b: NNC0519-0130 B and NNC0519-0130 CEXPERIMENTALParticipants will start treatment with formulation NNC0519-0130 B and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C.
Part 2a: NNC0519-0130 B and NNC0519-0130 CEXPERIMENTALParticipants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 B then NNC0519-0130 C.
Part 2b: NNC0519-0130 C and NNC0519-0130 BEXPERIMENTALParticipants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 C then NNC0519-0130 B.
Interventions
NameTypeDescription
NNC0519-0130 BDRUGNNC0519-0130 B will be administered subcutaneously.
NNC0519-0130 CDRUGNNC0519-0130 C will be administered subcutaneously.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female of non-childbearing potential. * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body Mass Index (BMI) between 27.0 kilogram per square meter (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to ex...

Countries:United States
Unlock Eligibility Criteria