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NNC0471-0119

Phase 1

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jan 3, 2023

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_CONTROLLED
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04655690A Study to Look at How Safe Insulin NNC0471-0119 is and How it Works in People With Type 1 Diabetes MellitusPHASE1 COMPLETED 48 — — Nov 9, 2020Nov 26, 2021Jan 3, 20231 Austria
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Study Endpoints
Primary Endpoints
Number of adverse events (AEs)
From investigational medicinal product (IMP) administration at day 1 (Visit 2) and up to 22 days post IMP administration (Visit 3)

Number of events

Secondary Endpoints
Number of hypoglycaemic episodes
0 to 24 hours after IMP administration
AUCNNC0471-0119,0-30 min/AUCNNC0471-0119,0-t: Ratio of the area under the serum NNC0471-0119 concentration-time curve from 0-30 min and 0-t, where t is the last observed time point with insulin concentration above lower limit of quantification (LLOQ).
0 to 12 hours after IMP administration
AUCNNC0471-0119,2h-t/AUCNNC0471-0119,0-t: Ratio of the area under the serum NNC0471-0119 concentration-time curve from 2 hours to t and 0 to t, where t is the last observed time point with insulin concentration above LLOQ.
0 to 12 hours after IMP administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC0471-0119EXPERIMENTALParticipants randomised to NNC0471-0119
Faster aspartACTIVE_COMPARATORParticipants randomised to faster aspart.
Interventions
NameTypeDescription
NNC0471-0119DRUGParticipants will be randomised to either of five dose levels 0.3, 0.6, 1.2, 2.4 or 3.6 of NNC0471-0119 nanomol per kilogram body weight, which will be administered as a single dose. NNC0471-0119 will be administered subcutaneously (s.c., under the skin) in fasting state.
Fast-acting insulin aspartDRUGParticipants will get a fixed dose of 0.2 units of fast-acting insulin aspart (Fiasp®) per kilogram body weight, administered subcutaneously (s.c., under the skin) in fasting state.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male subject or female subject of non-childbearing potential. Non-childbearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without...

Countries:Austria
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