Recruiting
Phase 1

NNC4005-0001

Sponsor:

Novo Nordisk A/S

Code:

NCT07214870

Conditions

Fatty Liver Disease

Eligibility Criteria

Sex: All

Age: 18 - 69

Healthy Volunteers: Not accepted

Interventions

NNC4005-001

Placebo

Study Details

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

Study ID

NCT07214870

Start date

Oct 8, 2025

Status verified date

Feb, 2026

Completion date

May 14, 2027

Anticipated

Primary completion date

May 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 69

Healthy Volunteers: Not accepted

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 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.

Exclusion criteria:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NNC4005-0001

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

placebo comparator: Placebo

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

Interventions

NNC4005-001

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

Placebo

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

Primary outcome measure

  • Number of Treatment-emergent adverse event (TEAEs) [ Time Frame: From dosing (day 1) until compeletion of end of study (EOS) visit on day 169 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

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

Locations

Altasciences Clinical Company, Inc

Recruiting

Montreal, Quebec, Canada, H3P 3P1

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-02-11.