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NNC0650-0013 A

Phase 1

Healthy Participants | Small molecule | Other |Novo Nordisk A/S|Last Updated: Dec 5, 2025

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 Trials1
Total Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06284798A Research Study of a New Medicine (NNC0650-0013) in Healthy MenPHASE1 COMPLETED 11 — — Jan 29, 2024Jul 25, 2024Dec 5, 20251 Germany
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Study Endpoints
Primary Endpoints
S.C. Cohort: Number of treatment emergent adverse events (TEAEs)
From time of dosing (day 1) until completion of the follow-up visit (day 75)

Measured as number of events.

Secondary Endpoints
S.C. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration time curve from time 0 to infinity after a single dose
From pre-dose (day 1) until completion of the follow up visit (day 75)
S.C. Cohort: Cmax,0188,SD: Maximum plasma concentration of NNC0519-0188 after a single dose
From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose
From pre-dose (day 1) until completion of the follow-up visit (day 75)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC0650-0013: Subcutaneous doseEXPERIMENTALParticipants will receive NNC0650-0013 subcutaneously in an ascending dose manner.
PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo to NNC0650-0013 subcutaneously.
NNC0650-0013: Intravenous doseEXPERIMENTALParticipants will receive NNC0650-0013 in an ascending dose manner intravenously.
Interventions
NameTypeDescription
NNC0650-0013 ADRUGNNC0650-0013 will be administered subcutaneously or intravenously.
PlaceboDRUGSubcutaneous administration.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Body mass index between 24.0 and 29.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening. * Considered to be otherwise healthy based on the medical history, physical examinat...

Countries:Germany
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