NNC4005-0001 for fatty liver in adults with increased 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

This trial will test whether the experimental medicine NNC4005-0001 is safe and well-tolerated in adults with higher body weight and elevated liver fat.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 69 Years
• Sex: All
• Sponsor: Novo Nordisk A/S (Industry-sponsored)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT07214870 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional study gives adult participants either NNC4005-0001 or a placebo and follows them for about 7 to 8 months to monitor safety and tolerability. Participants must be 18–69 years old, have a BMI of 27.0–40.0 kg/m², and have hepatic fat fraction ≥8% by MRI-PDFF prior to dosing. People with a prior or current diagnosis of metabolic dysfunction-associated steatohepatitis (MASH) or recent use of specific metabolic or antifibrotic therapies are excluded. The main focus is on collecting safety data and preliminary signals related to liver fat and tolerability.

Who should consider this trial

Good fit: Adults aged 18–69 with BMI 27.0–40.0 kg/m² and MRI-PDFF ≥8% who do not have a prior MASH diagnosis and are not using excluded medications are the intended participants.

Not a fit: People with a diagnosed MASH, prior or current use of antifibrotic or specified metabolic therapies, those outside the BMI or age ranges, or with other disqualifying medical conditions are unlikely to qualify or benefit from this study.

Why it matters

Potential benefit: If successful, this could identify a new safe treatment option that may reduce liver fat for adults with overweight and fatty liver.

How similar studies have performed: Other metabolic-targeting medicines (for example, some GLP-1 agonists) have shown reductions in liver fat in clinical studies, but NNC4005-0001 itself is a novel compound being tested for safety in this trial.

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.

Where this trial is running

Montreal, Quebec

• Altasciences Clinical Company, Inc — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Novo Nordisk

Conditions Fatty Liver Disease