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NNC4005-001

Phase 1

Fatty Liver Disease | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Feb 11, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07214870A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver FatPHASE1 RECRUITING 60 — — Oct 8, 2025May 14, 2027Feb 11, 20261 Canada
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Study Endpoints
Primary Endpoints
Number of Treatment-emergent adverse event (TEAEs)
From dosing (day 1) until compeletion of end of study (EOS) visit on day 169

Measured as count of events

Secondary Endpoints
AUC(0-last): The area under the NNC4005-0001 plasma concentration-time curve from time zero to last measurable concentration after a single dose
From dosing (day 1) to 48 hours post-dose
Cmax: The maximum concentration of NNC4005-0001 in plasma
From dosing (day 1) to 48 hours post-dose
tmax: The time from dose administration to the maximum plasma concentration of NNC4005-0001
From dosing (day 1) to 48 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC4005-0001EXPERIMENTALParticipants will receive a single dose of NNC4005-0001 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts.
PlaceboPLACEBO_COMPARATORParticipants in each cohort will receive placebo matched to NNC4005-0001 injected subcutaneously.
Interventions
NameTypeDescription
NNC4005-001DRUGNNC4005-0001 will be given as a single ascending dose via subcutaneous route
PlaceboDRUGPlacebo matched to NNC4005-0001 will be given via subcutaneous route
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Eligibility Criteria
Age Range18 Years — 69 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Aged 18-69 years (both inclusive) at the time of signing the informed consent. * Body Mass Index (BMI) of 27.0-40.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening process. * Hepatic fat fraction greater than or equal to (≥) 8% by magnetic resonance imaging p...

Countries:Canada
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07214870primaryCompletionDate: changed
LOWMay 24, 2026NCT07214870studyFirstPostDate: changed