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NCT Number: NCT07214870

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

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.

Recruiting

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Company, Inc

Montreal, Quebec, H3P 3P1, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC4005-001

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number of Treatment-emergent adverse event (TEAEs)

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

    Measured as count of events

Secondary outcomes

  1. AUC(0-last): The area under the NNC4005-0001 plasma concentration-time curve from time zero to last measurable concentration after a single dose

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

    microgram*hour per milliliter (μg*h/mL)

  2. Cmax: The maximum concentration of NNC4005-0001 in plasma

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

    Measured in microgram per millilitre

  3. tmax: The time from dose administration to the maximum plasma concentration of NNC4005-0001

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

    Hour

  4. t1/2: Half life

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

    Hour

  5. CLr: Renal clearance

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

    Liter/hour (L/h)

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NNC4005-0001 in Adults

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 9, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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