Study on the Effects of Vonafexor, Rosuvastatin Zinc, and Iohexol on Kidney Function in Patients with Impaired Renal Function and Suspected MASH

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Vonafexor on individuals with impaired kidney function and a condition known as Metabolic Associated Steatohepatitis (MASH). MASH is a liver disease that often occurs in people who are overweight or have diabetes. The purpose of the study is to understand how Vonafexor affects kidney function in people who have mild to moderate kidney issues and are suspected of having MASH.

Participants in the study will receive Vonafexor in the form of tablets. The study will also involve the use of a diagnostic agent called Iohexol, which is a type of contrast used to help assess kidney function. Some participants may receive a placebo instead of the active medication. The study will take place over several weeks, with regular check-ups to monitor kidney function and overall health. Participants will have their kidney function measured at different times during the study to see how it changes with the treatment.

The study aims to provide valuable information on how Vonafexor can help manage kidney function in people with suspected MASH. By participating, individuals will contribute to research that could lead to better treatments for those with similar health conditions. The study will also monitor any side effects or changes in health to ensure the safety of all participants.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, body mass index, and kidney function.

Participants must be between 18 and 75 years old, with a body mass index between 25.0 and 45.0 kg/m², and specific kidney function levels.

2 initial assessment

An initial assessment is conducted to establish baseline measurements for kidney function and other health parameters.

This includes tests to measure kidney filtration rates and other relevant health indicators.

3 medication administration

Participants receive vonafexor in tablet form, taken orally.

The dosage and frequency are determined by the study protocol and are administered over a specified period.

4 monitoring and follow-up

Regular monitoring occurs throughout the study to assess the effect of vonafexor on kidney function.

Measurements include plasma concentrations and changes in kidney filtration rates at various intervals, such as weeks 4, 8, 12, 16, 20, 24, and 28.

5 safety assessments

Safety assessments are conducted to monitor any adverse effects or changes in health status.

These assessments include laboratory tests, physical examinations, and monitoring of vital signs and heart activity.

6 final evaluation

A final evaluation is performed to determine the overall impact of the medication on kidney function and other health parameters.

This includes a comparison of baseline and post-treatment measurements.

Who Can Join the Study?

Must be a male or female.
Age must be between 18 and 75 years old, including both ages.
Must be overweight or have obesity. This means having a body mass index (BMI) between 25.0 and 45.0. BMI is a number calculated from your weight and height.
Can have type 2 diabetes, but the HbA1c level, which is a measure of blood sugar over time, must be 9.5% or lower.
Must have an eGFR between 30 and 90. eGFR is a test that checks how well your kidneys are working.
Must have signs of mild to higher liver fibrosis. This is shown by a FIBROTEST score of 0.28 or higher and/or a FIB-4 score of 1.3 or higher. These scores are tests that help understand the condition of your liver.

Who Cannot Join the Study?

Individuals with severe kidney problems cannot participate.
People with other serious health conditions that might interfere with the study are not eligible.
Participants who are pregnant or breastfeeding are excluded.
Anyone who has participated in another clinical trial recently may not join.
Individuals with a history of drug or alcohol abuse might be excluded.
People who are unable to follow the study procedures or attend scheduled visits cannot participate.
Anyone with allergies to the study medication or its ingredients is not eligible.
Participants who are taking certain medications that could interfere with the study drug are excluded.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
PROFIL Institut fuer Stoffwechselforschung GmbH	Neuss	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	22.03.2024

Trial locations

Investigated drugs:

Vonafexor is a medication being studied for its potential effects on kidney function. It is being tested in individuals who have impaired kidney function and are suspected of having MASH (Metabolic Associated Steatohepatitis). The main goal of the study is to see how vonafexor affects the kidneys, particularly in people whose kidney function is mildly to moderately reduced.

Investigated diseases:

Renal impairment

Impaired Renal Function – This condition occurs when the kidneys are not working as well as they should. It can lead to a buildup of waste products in the blood and cause symptoms like swelling, fatigue, and changes in urination. Over time, impaired renal function can progress, potentially leading to more severe kidney damage. The progression can vary depending on the underlying cause and other health factors. Monitoring kidney function is crucial to understanding how the condition is developing.

Metabolic Associated Steatohepatitis (MASH) – MASH is a liver condition characterized by inflammation and fat accumulation in the liver, often associated with metabolic disorders. It can develop in individuals with obesity, type 2 diabetes, or other metabolic syndromes. Over time, MASH can lead to liver damage and scarring. The progression of the disease can vary, with some individuals experiencing worsening liver function. Lifestyle factors, such as diet and exercise, can influence the progression of MASH.

Trial ID:

2023-509192-16-00

Protocol code:

EYP001-210

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Vonafexor, Rosuvastatin Zinc, and Iohexol on Kidney Function in Patients with Impaired Renal Function and Suspected MASH

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?