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

ConditionFatty Liver Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-69
SponsorNovo Nordisk A/S

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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/m²) (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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: NNC4005-0001Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Treatment-emergent adverse event (TEAEs)

Measured as count of events

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

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

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

Time frame
From dosing (day 1) to 48 hours post-dose
2

Cmax: The maximum concentration of NNC4005-0001 in plasma

Measured in microgram per millilitre

Time frame
From dosing (day 1) to 48 hours post-dose
3

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

Hour

Time frame
From dosing (day 1) to 48 hours post-dose
4

t1/2: Half life

Hour

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov
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