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New treatment option for Fatty Liver Disease
Official title A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver Fat
ClinicalTrials.gov ID: NCT07214870
What this study is testing
What is NNC4005-001?
NNC4005-001 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for fatty liver disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 69
You may be able to join if
- 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...
- No prior or present clinical history of metabolic dysfunction-associated steatohepatitis (MASH) diagnosis.
You likely can't join if
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.