Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A study to Assess the Effect of Vonafexor on Kidney Function in Subjects With Impaired Renal Function and Suspected MASH

This study is investigating a new medicine, Vonafexor, for individuals who have kidney problems and are thought to have MASH. MASH is a type of liver disease. The main goal is to find out if Vonafexor can improve how well the kidneys are working after 16 weeks of treatment. Researchers will compare kidney function before and after taking the medicine. They will also look at how the medicine moves through the body, monitor other measures like protein levels in urine, and keep a close eye on any side effects. This is a Phase II study, meaning it's an earlier stage of research designed to explore how effective and safe the treatment might be.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

ENYO Pharma

Enrolment target

Start

14 Mar 2024

Impaired renal function and suspected MASH

What is this study about?

This research study is looking into a new medication called Vonafexor. It's designed for people who have issues with their kidneys and also have a suspected condition called MASH. MASH stands for metabolic dysfunction-associated steatohepatitis, which is a type of serious liver disease. Essentially, the study wants to understand if Vonafexor can help improve how well the kidneys are working in individuals with these health concerns.

The main aim over the course of 16 weeks is to measure changes in kidney function. Doctors will assess this in a couple of ways: by using a special test involving a substance called iohexol, and by looking at standard blood tests for kidney function. They'll compare these measurements before the study medication starts and after 16 weeks of treatment. This will help them see if Vonafexor has a positive effect on kidney health.

Beyond just kidney function, the study will also closely monitor several other aspects. This includes how the body processes the medication, changes in urine tests (which can indicate kidney health), and any potential side effects. This thorough approach helps researchers get a full picture of how the new medicine works and whether it's safe and potentially helpful for patients.

Key takeaways

The study explores a new medicine, Vonafexor, for kidney problems and suspected MASH.
The main goal is to see if Vonafexor improves kidney function over 16 weeks.
Researchers will also track how the medicine works in the body and look for side effects.
Participation involves regular clinic visits for blood tests, urine tests, and health checks.
The study is for adults over 18 with specific kidney and liver conditions.
You can stop participating at any time.

Who may be eligible?

To join this study, participants must be at least 18 years old. The study is open to both men and women.

Key conditions for joining are having problems with your kidneys and also having been told you might have MASH. MASH is a specific kind of liver disease.

Further checks will be carried out by the study team to make sure it's safe and appropriate for you to take part. This will involve reviewing your full medical history.

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?
Do you have kidney problems?
Has your doctor told you that you might have MASH?
Are you able to attend clinic visits regularly for about 28 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given the study medication, Vonafexor, along with other medicines like Rosuvastatin and Iohexol which are used for monitoring. You will be taking Vonafexor over 16 weeks. Throughout this period, and for a short time afterwards, you will have several visits to the clinic.

These visits will involve getting blood samples taken at specific times (before and after taking the medicine), urine samples, physical check-ups, and tests like ECGs (heart tracings). Your kidney function will be carefully monitored using special tests. After the 16 weeks of treatment, there will be follow-up visits to see how you are doing off the medication, continuing until around week 28. The total duration of your participation would be approximately 28 weeks.

Potential risks and benefits

Participating in any clinical trial involves potential benefits and risks. You might find that Vonafexor improves your kidney function or helps with your MASH, though this is not guaranteed as it's still being investigated. You will also receive careful medical monitoring throughout the study. However, like all medications, Vonafexor could have side effects, which the study team will discuss with you and monitor 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
Germany

Common questions

What is MASH?

MASH stands for metabolic dysfunction-associated steatohepatitis. It's a serious type of liver disease where too much fat builds up in the liver, leading to inflammation and liver cell damage.

What does 'impaired renal function' mean?

It means your kidneys are not working as well as they should be. The kidneys are important for filtering waste from your blood.

What is Vonafexor?

Vonafexor is the name of the new medicine being tested in this study. It's being studied to see its effects on kidney function in people with kidney problems and suspected MASH.

Is this medicine available to everyone?

No, Vonafexor is an investigational medicine, meaning it's still being tested in clinical trials. It's not yet approved for general use.

How long will I be involved in the study?

If you participate, you will take the study medication for 16 weeks, and the full study, including follow-up visits, will last for about 28 weeks in total.