A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver Fat

NCT07214870 | Recruiting Phase 1

• 2 other identifiers: NN4005-8221UTN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to find out if NNC4005-0001 is well-tolerated and safe for people who have increased body weight and increased liver fat. Participants will receive either NNC4005-0001, which is the treatment being tested, or a placebo, which is a treatment that contains no active medicine. The study will last for about for about 7 to 8 months.

Conditions

Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Number of Treatment-emergent adverse event (TEAEs)

  Measured as count of events

  From dosing (day 1) until compeletion of end of study (EOS) visit on day 169

Secondary Outcomes (5)

• 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

• t1/2: Half life

  From dosing (day 1) to 48 hours post-dose

• CLr: Renal clearance

  From dosing (day 1) to 48 hours post-dose

Study Arms (2)

NNC4005-0001

EXPERIMENTAL

Participants will receive a single dose of NNC4005-0001 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts.

Drug: NNC4005-001

Placebo

PLACEBO COMPARATOR

Participants in each cohort will receive placebo matched to NNC4005-0001 injected subcutaneously.

Drug: Placebo

Interventions

NNC4005-001 DRUG

NNC4005-0001 will be given as a single ascending dose via subcutaneous route

NNC4005-0001

Placebo DRUG

Placebo matched to NNC4005-0001 will be given via subcutaneous route

Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 proton density fat fraction (MRI-PDFF) within 17 days prior to dosing.
• No prior or present clinical history of metabolic dysfunction-associated steatohepatitis (MASH) diagnosis.

You may not qualify if:

• Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• Previous or current use of therapies for MASH or antifibrotic therapies (authorised or within aclinical trial).
• Use of high-dose vitamin E \[greater than (\>) 800 international unit (IU) per day\], glucagon-like peptide-1 (GLP-1) agonists (such as liraglutide, dulaglutide, or semaglutide), glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 agonists (such as tirzepatide), or pioglitazone within 6 months prior to screening.
• Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) levels greater than or equal (≥) 1.5× Upper Limit of Normal (ULN) at screening.
• Total bilirubin levels \> 1.5 times ULN if direct bilirubin is within Normal Limits (WNL) at screening.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Altasciences Clinical Company, Inc

Montreal, Quebec, H3P 3P1, Canada

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Clinical Transparency' (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: October 9, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): May 14, 2027
• Study Completion (Estimated): May 14, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

CA (1)