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NNC0650-0013 A

Phase 1

Undisclosed | Small molecule | Other |Novo Nordisk A/S|Trials Updated: Dec 5, 2025

NNC0650-0013 A development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2024

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

NNC0650-0013 A clinical trials

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
Healthy ParticipantsUnlock trial analytics

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?

NNC0650-0013 A is an investigational small molecule medicine being developed by Novo Nordisk A/S. It has been studied in a Phase 1 research trial in healthy male participants. The specific disease or condition it is intended to treat has not been disclosed.

Who makes NNC0650-0013 A?

NNC0650-0013 A is being developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical program for this investigational small molecule.

What phase is NNC0650-0013 A in?

NNC0650-0013 A is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA.

What clinical trials is NNC0650-0013 A in?

NNC0650-0013 A has been evaluated in one Phase 1 trial, NCT06284798, titled A Research Study of a New Medicine (NNC0650-0013) in Healthy Men. The trial enrolled 11 participants in Germany, was randomized, double-blind, and placebo-controlled, and is now completed.

What is NNC0650-0013 A used for?

NNC0650-0013 A is an investigational medicine with no disclosed therapeutic indication. Its only reported clinical study was conducted in healthy male volunteers rather than in patients with a specific disease, so no approved or intended use has been established.