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NNC0471-0119 H

Phase 1

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Sep 2, 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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06809621A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 1 Diabetes When Given by an Insulin PumpPHASE1 COMPLETED 43 — — Jan 29, 2025Jul 28, 2025Sep 2, 20251 Germany
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Study Endpoints
Primary Endpoints
AUC(GIR,0-1h,basal-corrected): Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to 1 hour
0 to 1 hour after bolus infusion

Measured in milligram per kilogram (mg/kg).

Secondary Endpoints
AUC(GIR,0-t,basal-corrected): Area under the basal-corrected GIR-time curve from 0 to t
0 to 9 hours after bolus infusion
AUC(GIR,0-1h,basal-corrected)/AUC(GIR,0-t,basalcorrected):Ratio of the area under the basal-corrected GIR-time curve from 0 to 1 hour and 0 to t
0 to 9 hours after bolus infusion
GIR(max,basal-corrected): Maximum observed basal-corrected GIR
0 to 9 hours after bolus infusion
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC0471-0119 H then Insulin AspartEXPERIMENTALParticipants will receive NNC0471-0119 H subcutaneously (s.c.) in period 1 followed by insulin aspart s.c. in period 2.
Insulin Aspart then NNC0471-0119 HACTIVE_COMPARATORParticipants will receive insulin aspart s.c. in period 1 followed by s.c. NNC0471-0119 H in period 2.
Interventions
NameTypeDescription
NNC0471-0119 HDRUGNNC0471-0119 H will be administered subcutaneously.
Insulin aspartDRUGInsulin aspart will be administered subcutaneously.
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female aged 18-64 years (both inclusive) at the time of signing the informed consent. * Diagnosed with Type 1 Diabetes (T1D) greater than or equal to (≥) 1 year before screening. * Insulin administration using continuous subcutaneous insulin infusion via a pump greater...

Countries:Germany
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