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NNC0113-6856

Phase 1

Healthy Volunteers | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Dec 31, 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 Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05521256A Research Study of a New Medicine NNC0113-6856 in Healthy MalesPHASE1 COMPLETED 70 — — Aug 26, 2022Mar 27, 2023Dec 31, 20253 Germany
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Study Endpoints
Primary Endpoints
Number of adverse events
From time of dosing (day 1) until completion of the follow-up visit (Day 42)

Measured as number of events.

Secondary Endpoints
For oral cohorts- AUC0-tz,sema,single dose (SD): Area under the semaglutide plasma concentration-time curve from time 0 to tz after a single dose, where tz is the time of last quantifiable concentration
From pre-dose (day 1) to completion of follow-up visit (Day 42)
For oral cohorts- AUC0-infinity (∞),sema,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose
From pre-dose (day 1) to completion of follow-up visit (Day 42)
For oral cohorts- Cmax,sema,SD: Maximum observed plasma concentration of semaglutide after a single dose
From pre-dose (day 1) to completion of follow-up visit (day 42)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC0113-6856 (Oral Cohort)EXPERIMENTALParticipants will receive single oral dose of NNC0113-6856 tablets in dose escalated manner.
PlaceboPLACEBO_COMPARATORParticipants will receive single oral dose of placebo (NNC0113-6856) tablets in dose escalated manner.
NNC0113-6856 (i.v. Cohort)EXPERIMENTALParticipants will receive single dose of 1.5 milligrams (mg) NNC0113-6856 intravenously (i.v.).
Interventions
NameTypeDescription
NNC0113-6856DRUGParticipants will receive NN0113-6856 orally or intravenously.
PlaceboDRUGParticipants will receive matching placebo of NNC0113-6856 for each of the oral cohorts.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Male. * Aged 18-55 years (both inclusive) at the time of signing informed consent. * Body mass index between 20.0 and 27.0 kilogram per meter square (kg/m\^2)(both inclusive). Exclusion Criteria: * Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percent (%) (...

Countries:Germany
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