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NNC0497-0040

Phase 1

Type 1 Diabetes (T1D) | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jun 4, 2026

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment146
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07578584A Research Study Investigating the Effect of NNC0497-0040 in Healthy Participants, Participants With Overweight or Obesity, and Participants With Type 1 Diabetes With Overweight or ObesityPHASE1 RECRUITING 146May 7, 2026Feb 18, 2028Jun 4, 20261 Germany
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Study Endpoints
Primary Endpoints
Number of adverse events
Day 1 up to Week 6

Measured in events

Secondary Endpoints
Area under the serum NNC0497-0040 concentration time curve
Day 1
Cmax: Maximum observed serum NNC0497-0040 concentration
Day 1
Area under the serum NNC0497-0040 concentration time curve at steady state
MAD1-2: Week 12; MAD3: Week 20
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SADEXPERIMENTALParticipants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
MAD1EXPERIMENTALParticipants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
MAD2EXPERIMENTALParticipants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
MAD3EXPERIMENTALParticipants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
MAD4EXPERIMENTALParticipants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
Interventions
NameTypeDescription
NNC0497-0040DRUGNNC0497-0040 will be administered subcutaneously.
PlaceboDRUGPlacebo will be administered subcutaneously.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

For SAD cohorts Inclusion Criteria: * Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening. * Body mass index between 18.5 kilogram per m\^2 and 29.9 kilogram per m\^2 (both inclusive) at screening. * Considered to be generally healthy based on the medical hi...

Countries:Germany
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07578584Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 4, 2026NCT07578584Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 4, 2026NCT07578584Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 4, 2026NCT07578584Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 26, 2026NCT07578584primaryCompletionDate: changed
LOWMay 24, 2026NCT07578584studyFirstPostDate: changed
LOWMay 21, 2026NCT07578584NEW_TRIAL: changed
LOWMay 21, 2026NCT07578584NEW_TRIAL: changed