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Recruiting NCT07214870

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

Phase I Interventional Fatty Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NNC4005-001, Placebo.
Who it may be relevant to
Registry conditions: Fatty Liver Disease. Basic parameters: 18 years — 69 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Drug NNC4005-001
    NNC4005-0001 will be given as a single ascending dose via subcutaneous route
  • Drug Placebo
    Placebo matched to NNC4005-0001 will be given via subcutaneous route

Primary outcome measures

  • Number of Treatment-emergent adverse event (TEAEs) [Time frame: From dosing (day 1) until compeletion of end of study (EOS) visit on day 169]
Secondary outcome measures (5)
  • 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]
  • Cmax: The maximum concentration of NNC4005-0001 in plasma [Time frame: From dosing (day 1) to 48 hours post-dose]
  • 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]
  • t1/2: Half life [Time frame: From dosing (day 1) to 48 hours post-dose]
  • CLr: Renal clearance [Time frame: From dosing (day 1) to 48 hours post-dose]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Altasciences Clinical Company, Inc — Montreal

Identifiers

NCT: NCT07214870 · NN4005-8221 · UTN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗