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NNC4005-001

Phase 1

Fatty Liver Disease | Small molecule | Gastrointestinal |Novo Nordisk A/S|Trials Updated: Oct 13, 2026

NNC4005-001 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

NNC4005-001 clinical trials

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
ACTIVE NOT_RECRUITING29 Analytics
PHASE1ACTIVE NOT_RECRUITING
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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Recent Changes (Last 90 Days)

HIGHOct 13, 2026NCT07214870Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHOct 13, 2026NCT07214870Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about NNC4005-001

What is NNC4005-001?

NNC4005-001 is an investigational small molecule developed by Novo Nordisk A/S for fatty liver disease. It is in Phase 1 clinical development and is being studied in adults with increased body weight and liver fat. It has not been approved by any regulatory agency and remains an experimental therapy.

What is NNC4005-001 used for?

NNC4005-001 is being studied for fatty liver disease in adults who have increased body weight and liver fat. The research program is in Phase 1, so the drug is investigational and is not yet available as a treatment. Its use is currently limited to clinical trial participants.

Who makes NNC4005-001?

NNC4005-001 is developed by Novo Nordisk A/S, which trades under the ticker NVO. The company is running the clinical program for this small molecule candidate in fatty liver disease.

What phase is NNC4005-001 in?

NNC4005-001 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The program currently has one active trial, which is no longer recruiting participants.

What clinical trials is NNC4005-001 in?

NNC4005-001 is being evaluated in the Phase 1 trial NCT07214870, titled a research study of a potential new medicine for liver disease in adult participants with increased body weight and liver fat. The trial is active but not recruiting, is placebo controlled and double blind, and enrolled 29 participants in Canada.

Is NNC4005-001 tested in healthy volunteers?

No. The Phase 1 trial NCT07214870 for NNC4005-001 enrolls adults with fatty liver disease and increased body weight rather than healthy volunteers. Participants must be 18 years or older, and the study accepts all sexes. It is conducted in Canada and is currently active but not recruiting.