Fatty Liver Disease
Conditions
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.
Interventions
DRUGNNC4005-001
NNC4005-0001 will be given as a single ascending dose via subcutaneous route
DRUGPlacebo
Placebo matched to NNC4005-0001 will be given via subcutaneous route
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Canada
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency' (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed