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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fatty Liver Disease
• Intervention / Treatment: Drug: NNC4005-001; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3P 3P1
      • Recruiting
      • Altasciences Clinical Company, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC4005-0001; Participants will receive a single dose of NNC4005-0001 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts.	Drug: NNC4005-001; NNC4005-0001 will be given as a single ascending dose via subcutaneous route
Placebo Comparator: Placebo; Participants in each cohort will receive placebo matched to NNC4005-0001 injected subcutaneously.	Drug: Placebo; Placebo matched to NNC4005-0001 will be given via subcutaneous route

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC(0-last): The area under the NNC4005-0001 plasma concentration-time curve from time zero to last measurable concentration after a single dose	microgram*hour per milliliter (μg*h/mL)	From dosing (day 1) to 48 hours post-dose
Cmax: The maximum concentration of NNC4005-0001 in plasma	Measured in microgram per millilitre	From dosing (day 1) to 48 hours post-dose
tmax: The time from dose administration to the maximum plasma concentration of NNC4005-0001	Hour	From dosing (day 1) to 48 hours post-dose
t1/2: Half life	Hour	From dosing (day 1) to 48 hours post-dose
CLr: Renal clearance	Liter/hour (L/h)	From dosing (day 1) to 48 hours post-dose

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency' (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2025
• Primary Completion (Estimated): May 14, 2027
• Study Completion (Estimated): May 14, 2027

Study Registration Dates

• First Submitted: October 6, 2025
• First Submitted That Met QC Criteria: October 6, 2025
• First Posted (Actual): October 9, 2025

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: NN4005-8221; UTN (Other Identifier: U1111-1319-8000)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No