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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment11

FDA Designations

No designations recorded

Clinical trial landscape

NNC0650-0013 A · 1 trial · 1 indication

Phase 1 1
NCT06284798A Research Study of a New Medicine (NNC0650-0013) in Healthy MenHealthy Participants
COMPLETED11 Analytics
PHASE1COMPLETED
A Research Study of a New Medicine (NNC0650-0013) in Healthy Men
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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 to 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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Frequently asked questions about NNC0650-0013 A

What is NNC0650-0013 A used for?

NNC0650-0013 A is an investigational small molecule being studied in healthy participants. It is being developed by Novo Nordisk A/S and is currently in Phase 1 clinical development. The drug is not approved for any indication and remains under investigation.

Who makes NNC0650-0013 A?

NNC0650-0013 A is being developed by Novo Nordisk A/S, a biopharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational small molecule.

What phase is NNC0650-0013 A in?

NNC0650-0013 A is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under clinical investigation.

What clinical trials is NNC0650-0013 A in?

NNC0650-0013 A has one completed Phase 1 clinical trial, identified as NCT06284798. The study, titled 'A Research Study of a New Medicine (NNC0650-0013) in Healthy Men,' was conducted in Germany and enrolled 11 male participants aged 18 years and older.

Is NNC0650-0013 A the same as NNC0650-0013?

NNC0650-0013 A is the drug name used in the clinical trial record, while the trial title refers to the medicine as NNC0650-0013. Both names refer to the same investigational small molecule being developed by Novo Nordisk A/S.