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NNC4005-001

Phase 1

Fatty Liver Disease | Small molecule | Gastrointestinal |Novo Nordisk A/S|Last Updated: Feb 11, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

NNC4005-001 · 1 trial · 1 indication

Phase 1 1
NCT07214870A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver FatFatty Liver Disease
RECRUITING60 Analytics
PHASE1RECRUITING
A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver Fat
Fatty Liver DiseaseUnlock trial analytics

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 to 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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Frequently asked questions about NNC4005-001

What is NNC4005-001 used for?

NNC4005-001 is an investigational small molecule being developed for fatty liver disease. It is currently in Phase 1 clinical development, studied in adult participants with increased body weight and liver fat. The drug is not yet approved and remains under investigation for this condition.

Who makes NNC4005-001?

NNC4005-001 is being developed by Novo Nordisk A/S, a biopharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical research to evaluate this potential new medicine for fatty liver disease.

What phase is NNC4005-001 in?

NNC4005-001 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to study the drug in adults with increased body weight and liver fat.

What clinical trials is NNC4005-001 in?

NNC4005-001 is being studied in one active Phase 1 clinical trial with the identifier NCT07214870. This randomized, double-blind, placebo-controlled study enrolls 60 participants with fatty liver disease in Canada. The trial is currently recruiting adults aged 18 years and older.

Is NNC4005-001 the same as NNC4005-0001?

Yes, NNC4005-001 is the same drug as NNC4005-0001. The clinical trial NCT07214870 refers to the drug as NNC4005-0001, while the drug name is listed as NNC4005-001. Both names refer to the same investigational medicine for fatty liver disease.