Non-Alcoholic Steatohepatitis (NASH)

Reimbursement: Up to £2490, plus transport or reasonable travel expenses.

About This clinical research study

If you are overweight or obese with a body mass index (BMI) of 25kg/m2 or over, or if you are from an Asian ethnic background with a body mass index of 23kg/m2 or above, you may be interested in a clinical trial running at MAC Clinical Research investigating a potential treatment for Non-Alcoholic Steatohepatitis (NASH disease).

A prior diagnosis of nonalcoholic steatohepatitis is not essential as this will be tested for during the recruitment process, as below. However, if you already have NASH, or any of the following apply; Non-Alcoholic Fatty Liver Disease (NAFLD), type 2 diabetes, high blood pressure (hypertension), high cholesterol, or high triglycerides your chance of eligibility could be greatly increased.

NAFLD and NASH, also known as MAFLD and MASH (Metabolic Associated fatty liver disease / Metabolic Associated Steatohepatitis) occurs when cells in the liver, called hepatocytes, builds up fat deposits (known as steatosis). NASH is the more serious progressive form of NAFLD and occurs when injury and inflammation to the liver causes scarring (fibrosis). The severity of NASH is dependent on the level of fibrosis in the liver (stages 1 to 4) and life expectancy with fatty liver disease can shorten significantly.

Causes of non alcoholic fatty liver disease include being overweight, low physical activity and conditions such as type 2 diabetes, high blood pressure, high triglycerides and high cholesterol. Unfortunately, people do not usually experience or notice symptoms of a non-alcoholic fatty liver, which makes it difficult to diagnose NAFLD or even NASH and up to 80% of people remain undiagnosed. Because of this testing for fatty liver often does not happen for many years when scarring may already have occurred.

Treatments for NASH or fatty liver condition have two main arms: halting progress of the condition and helping to repair as much of the scarring as possible. The main treatment for both is changes to lifestyle; eating a healthy diet, increase in physical activity, and losing weight (if necessary). There are currently no medicines in Europe that specifically treat NASH or NAFLD and there is a real need for new treatments for fatty liver disease.

The purpose of this trial is to evaluate how effective and safe the investigational medicine is in the treatment of NASH. It is hoped the investigational medicine will reduce a protein found specifically in the hepatocytes of the liver and believed to be strongly associated with the development and progression of NASH. 

The trial is a placebo (a “dummy medicine” that has no active ingredient) controlled, double-blind (neither yourself or the trial doctor will know if you are receiving the investigational medicine or placebo) study. This means you may receive placebo or the investigational medicine, there is a 2 in 3 chance of receiving the investigational medicine versus placebo, which you receive is determined by chance, known as randomisation.

Reimbursement: Up to £2490, plus transport or reasonable travel expenses.

Clinics

Greater Manchester, South Staffordshire and South Yorkshire

Therapy Area

Fatty Liver Disease NASH

Gender and Age

Males and Females aged 18 - 75

A full description of the clinical trial will be given before you decide to take part, both over the phone and during an appointment at a MAC clinic. This will include you receiving the full patient information sheet (PIS).

There is no requirement of a prior diagnosis of NASH or NAFLD to register your interest, and prior to enrolment onto the trial there will be an initial recruitment period which will include a telescreen, a pre-screen chat and a pre-screen visit where potentially some health assessments may be conducted to help confirm the presence of NASH. Any tests will be provided free of charge and there is no obligation to take part in the clinical trial. However, trial participants will receive up to £2,490 for their time and commitment, travel expenses or transport will also be provided.

The duration of the trial will be up to 76 weeks with a total of up to 21 outpatient visits to a MAC clinic.

Reimbursement: Up to £2490, plus transport or reasonable travel expenses.

Key Inclusion Criteria

Key Exclusion Criteria

Other eligibility criteria will apply. Please contact MAC for more information.

If you are eligible you will receive a comprehensive health screen. Your GP will be fully informed of your participation and provided with any information relevant to your healthcare.

ABOUT CLINICAL RESEARCH STUDIES

Clinical research studies are performed as a way of bringing about progress in medicine and research. Clinical research studies make it possible to scientifically assess the properties of a drug, to demonstrate the effectiveness and safety of a treatment or a medical device, or to learn more about a disease and methods to diagnose and monitor it.

If the study is successful, it may be an important step towards developing a promising new treatment.

MAC Clinical Research is currently conducting a new clinical research study for Non-Alcoholic Steatohepatitis (NASH).

If you would like more information, please fill in the form below and we will be in touch…

Alternatively, please call our recruitment team on freephone 0800 633 5507.

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