Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A Randomised, Open-Label, Single-Centre, Study to Evaluate the Bioequivalence of Lanifibranor

This study is about a medicine called Lanifibranor, which is being investigated for a liver condition known as non-alcoholic steatohepatitis (NASH). NASH is a type of fatty liver disease that can cause liver damage over time. This particular study is in its very early stages, often called Phase 1, and focuses on 'bioequivalence'. This means researchers want to check if a new way of making or giving the medicine works just as well in the body as an existing version. It's like asking if two different brands of the same common painkiller have the same effect. This study will involve healthy adult volunteers and will help understand how the medicine is absorbed, used, and cleared by the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Inventiva

Enrolment target

Start

04 Feb 2026

What is this study about?

This study is looking into a potential new treatment called Lanifibranor for a liver condition called non-alcoholic steatohepatitis, or NASH. NASH is a serious type of fatty liver disease where there is a build-up of fat in the liver, along with inflammation and damage to liver cells. Over time, NASH can lead to more severe liver problems, so finding effective treatments is very important.

This specific study is a very early-stage trial, sometimes called a Phase 1 or 'human pharmacology' study. It's not about seeing if the medicine cures NASH yet, but rather about checking how the medicine behaves inside the human body. The main goal, called 'bioequivalence', is to see if a new form or formulation of Lanifibranor acts the same way as a previously studied version. For example, if a medicine is made into a new tablet form, this study would check if the new tablet delivers the same amount of medicine to the body at the same speed as the original version.

Understanding how a medicine is absorbed, distributed, used, and removed by the body is a crucial step before it can be widely used. These early studies help ensure that any new form of a medicine will be safe and effective before moving on to larger studies that test its benefits for patients with specific conditions like NASH.

Key takeaways

This study is testing a medicine called Lanifibranor for liver disease (NASH).
It's an early-stage study to see how a new version of the medicine works in the body.
The study is looking for healthy adult volunteers, aged 18 and over, of any gender.
Participation involves clinic visits, taking the medicine, and blood/urine tests.
Your involvement helps medical research, but there are no guaranteed direct health benefits for you.

Who may be eligible?

This study is looking for healthy adults to take part. You need to be at least 18 years old. People of any gender can join.

While the main condition being studied (NASH) is a liver disease, this early-stage trial typically recruits healthy general volunteers, not patients with NASH. This is so researchers can understand how the medicine works in the body without other health conditions making it complicated.

All volunteers will need to go through a screening process to make sure they are generally healthy enough for the study. This usually involves health checks, questions about your medical history, and blood tests.

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 18 years old or older?
Are you generally healthy?
Are you willing to visit the clinic for appointments?
Are you happy to provide blood or urine samples?
Are you available for a few weeks to a couple of months for the study duration?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check your health. If you're suitable, you'll visit the study centre several times. During these visits, you'll receive the study medicine (Lanifibranor) and have samples taken, like blood or urine, to see how your body handles the medicine. You might be asked to stay at the study centre for a short period, possibly overnight or for a few days, especially when you receive the medicine. The total time you spend in the study will vary, but similar studies can last from a few weeks to a couple of months, including follow-up checks after you've stopped taking the medicine. You’ll be told the exact schedule before you agree to take part.

Potential risks and benefits

Participating in this study may not directly benefit your health, as it's an early-stage trial focused on understanding how the medicine works. However, your participation could help advance medical knowledge and potentially contribute to developing future treatments for NASH. Like all medicines, Lanifibranor may have side effects, and the research team will explain any known risks and monitor you closely. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
France

Common questions

What is NASH?

NASH stands for Non-alcoholic steatohepatitis. It's a serious liver condition where there's fat in the liver, along with swelling and damage, not caused by drinking alcohol.

What does 'bioequivalence' mean?

Bioequivalence means comparing two forms of the same medicine to see if they deliver the same amount of the active drug to your body at the same speed and to the same extent.

Will this medicine cure my NASH?

This early-stage study is not designed to test if the medicine cures NASH. It's to understand how the medicine works in the body. It will likely involve healthy volunteers.

What will I have to do if I join?

You'll have health checks, receive the study medicine, and have blood or urine samples taken to see how your body uses the medicine. You might need to stay at a clinic for a short time.

Are there any side effects?

All medicines can have side effects. The study team will explain any known risks of Lanifibranor and will monitor you carefully during the study.