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NNC0113-2023

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jan 10, 2020

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 Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03617081First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.PHASE1 COMPLETED 40 — — Aug 9, 2018Dec 13, 2018Jan 10, 20201 United States
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Study Endpoints
Primary Endpoints
Number of treatment emergent adverse events (TEAEs)
From time of dosing (day 1) until completion of the follow-up visit (day 43)

Count of events

Secondary Endpoints
AUC0-∞,2023,SD; the area under the NNC0113-2023 plasma concentration-time curve from time 0 to infinity after a single dose of oral NNC0113-2023
From baseline (day 1) to post treatment follow-up (day 43)
Cmax,2023,SD; the maximum plasma concentration of NNC0113-2023 after a single dose of oral NNC0113-2023
From baseline (day 1) to post treatment follow-up (day 43)
AUC0-24h,SNAC,SD; the area under the SNAC plasma concentration-time curve from time 0 to 24 hours after a single dose of oral NNC0113-2023
From baseline (day 1) to 24 hours after dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC0113-2023EXPERIMENTALParticipants will receive increasing doses of NNC0113-2023 on day 1. Each participant will receive only a single dose.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo (NNC0113-2023)
Interventions
NameTypeDescription
NNC0113-2023DRUGParticipants will receive dose levels of 1 mg, 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of NNC0113-2023 orally. Each participant will receive only one dose.
Placebo (NNC0113-2023)DRUGParticipants will receive NNC0174-0833 matched placebo orally.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male aged 18 - 45 years (both inclusive) at the time of signing informed consent. * Body mass index between 20.0 kg/m\^2 and 29.9 kg/m\^2 (both inclusive). * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ...

Countries:United States
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