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

Not Applicable

Not yet recruiting

• Conditions: Fatty Liver Disease
• Interventions: Drug: NNC4005-001; Drug: Placebo

• Registration Number: NCT07214870
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-06
• Study First Submitted QC: 2025-10-06
• Last Update Submitted: 2025-10-06
• Study Start: 2025-10-07
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Primary Completion: 2027-05-14
• Study Completion: 2027-05-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
NNC4005-0001	NNC4005-001	Participants will receive a single dose of NNC4005-0001 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts.
Placebo	Placebo	Participants in each cohort will receive placebo matched to NNC4005-0001 injected subcutaneously.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	microgram\*hour per milliliter (μg\*h/mL)
Cmax: The maximum concentration of NNC4005-0001 in plasma	From dosing (day 1) to 48 hours post-dose	Measured in microgram per millilitre
tmax: The time from dose administration to the maximum plasma concentration of NNC4005-0001	From dosing (day 1) to 48 hours post-dose	Hour
t1/2: Half life	From dosing (day 1) to 48 hours post-dose	Hour
CLr: Renal clearance	From dosing (day 1) to 48 hours post-dose	Liter/hour (L/h)

Trial Locations

Locations (1)

Altasciences; 🇨🇦 Montreal, Quebec, Canada