RecruitingPHASE1INTERVENTIONAL

Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases

This study is investigating a new medicine called NNC0581-0001 for people with liver conditions, specifically fatty liver disease (hepatic steatosis) and suspected inflammation (steatohepatitis). We want to find out if this new medicine is safe, how well people tolerate it, and how it moves through the body. Participants will receive the medicine as an injection under the skin once a month for three months. Some will get the new medicine, while others will receive a 'dummy' treatment (placebo) – chosen randomly. The new medicine is not yet available from doctors. The study will last around 58 weeks in total, and aims to provide important information about this potential new treatment.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Novo Nordisk A/S

Enrolment target

Start

12 Mar 2025

Estimated completion

15 Nov 2027

Healthy Volunteers Hepatic Steatosis

What is this study about?

This study is exploring a new medicine for certain liver conditions. Our livers are vital organs, and sometimes they can develop issues like hepatic steatosis, which means there's too much fat in the liver. In some cases, this can lead to inflammation, known as steatohepatitis. This new medicine, called NNC0581-0001, is being tested as a potential treatment for these conditions. Since it's a new medicine, it's not something doctors can prescribe yet.

The main goals of the study are to understand if NNC0581-0001 is safe for people to take, how well their bodies handle it, and how it works once it's in the body. We'll be giving the medicine in two different dose levels, delivered as injections under the skin once a month for three months. Some participants will receive the active medicine, while others will get a placebo, which looks just like the real medicine but contains no active ingredients. This helps scientists compare the effects accurately.

Taking part in a study like this is an important way to help develop new treatments that could benefit many people in the future. The whole study process, from start to finish, will take about 58 weeks. During this time, researchers will carefully monitor participants' health and how they react to the treatment.

Key takeaways

Exploring a new injection for liver conditions like fatty liver disease.
Compares the new medicine (NNC0581-0001) with a dummy treatment (placebo).
Checks safety, how the body handles the medicine, and potential effects.
Involves monthly injections for 3 months, with follow-up over 58 weeks.
Aims to help develop future treatments for liver diseases.
Participation includes regular health checks and monitoring.

Who may be eligible?

To join this study, you would generally need to be a man or a woman who can't have children, aged between 18 and 69 years old. Your body mass index (BMI) should be 25 or higher, and scans of your liver should show that at least 10% of it is made up of fat. You also need to be in good general health, as assessed by a doctor, based on your medical history, a physical check-up, and blood tests.

For a specific part of the study that involves a liver biopsy (where a small sample of liver tissue is taken), there are extra conditions. Your blood test for liver enzyme (ALT) would need to be above a certain level, and a special scan (FibroScan) measuring liver stiffness would need to be between 8 and 12 kPa. If you've previously been diagnosed with a specific liver condition called MASH through a biopsy, you might also be able to join this particular group.

There are also reasons why you might not be able to join. For example, if you have any health problems that the study doctors think might put your safety at risk, or if certain blood test results are too far outside the normal range. This includes severely abnormal values for liver enzymes, bilirubin, or kidney function. If your blood tests show these severe abnormalities at the start, you won't be able to re-test to try and qualify.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 69 years old?
Is your BMI 25 or higher?
Do scans show at least 10% fat in your liver?
Are you generally in good health, as confirmed by a doctor?
Are you a woman who can't have children (e.g., post-menopause or had a hysterectomy), or a man?
Are your liver and kidney blood tests within acceptable limits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will last for approximately 58 weeks in total. Here's a general idea of what's involved:

* **Screening Visits:** You'll have initial appointments to check if you're suitable for the study. This will include medical history, a physical exam, various blood tests, heart readings (ECG), and an MRI scan of your liver. * **Treatment Period:** If you qualify, you'll receive the study medicine (either NNC0581-0001 or a placebo) once a month for three months. This will be given as an injection under the skin by a healthcare professional. * **Assessments:** Throughout the study, you'll have regular check-ups, blood tests, and potentially further MRI scans to monitor your health, how the treatment is affecting you, and how your body is handling the medicine. Some participants in a specific group will also have liver biopsies at the start and end of the treatment period. * **Follow-Up:** After the three months of treatment, you'll continue to have follow-up visits and assessments for the remainder of the 58 weeks to make sure you're well and to gather all necessary information.

You will be closely monitored by the study team at all times.

Potential risks and benefits

Taking part in a clinical study can have potential benefits, like allowing you to access a new, investigational medicine that isn't yet widely available. You'll also receive regular medical assessments and monitoring throughout the study, which could provide valuable insights into your health. However, there are also potential risks; the new medicine might cause side effects, some of which could be unknown at this stage. There's also no guarantee that the medicine will improve your liver condition, as it's still being tested. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Parexel Research Unit
Verified postcode
Harrow, United Kingdom· Recruiting

Common questions

What is 'hepatic steatosis'?

It means you have too much fat in your liver. Sometimes this is called 'fatty liver disease'.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps us see how much of the effect is due to the actual medicine.

Will I know if I'm getting the real medicine or the placebo?

No, you won't know, and neither will the study doctors initially. This is called 'blinding' and helps ensure the study results are fair and accurate.

How is the medicine given?

The medicine is given as an injection under your skin, similar to some diabetes or allergy injections.

How long will I be in the study?

The study will last for about 58 weeks, which is just over a year.

How to find out more

Novo Nordisk

clinicaltrials@novonordisk.com (+1) 866-867-7178 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.