Nonalcoholic Steatohepatitis (NASH) Research

Nonalcoholic Steatohepatitis (NASH) is a progressive fatty liver disease which can lead to serious health complications, including cirrhosis, liver disease, liver cancer, and death. NASH is inflammation in the liver caused by excess fat. It disrupts liver function. There are currently no approved treatments available for NASH. Therefore, clinical trials are needed to explore new treatment options.

We are conducting a research study for volunteers that will evaluate an investigational medication for Nonalcoholic Steatohepatitis (NASH).

You may be eligible if you:

• Are at least 18 years old
• Have NASH
• Do not have cirrhosis or other chronic liver diseases
• Do not have type 1 diabetes

There are additional criteria to meet to qualify for this study. Study participation is voluntary and free of charge. A stipend for time and travel will be provided. No health insurance is required to participate.

For more information call
(352) 341-2100
Or sign up below, and our friendly staff will call you!

Non-Invasively Diagnosed NASH/MASH and NAFLD/MASLD

If you have  NASH/MASH or NAFLD/MASLD, you may qualify for one of our research studies.

Qualified volunteers may receive at no cost:

• investigational medication
• study-related care from a local doctor
• possible compensation

Health insurance isn’t required to participate.
Ask your doctor or contact our clinic for more information.

Or sign up below and we will contact you!

Study Information below is from Clinicaltrials.gov

Inclusion Criteria:

Main Study Only:

• Males and non-pregnant, non-lactating females between 18 – 80 (between 19-80 in the Republic of Korea) years of age inclusive, on the day of signing informed consent

• Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes

• Suspected or confirmed diagnosis of NASH/MASH or NAFLD/MASLD or non-invasively diagnosed NASH/MASH or NAFLD/MASLD

Open-Label Rollover

• Prior participation in the placebo arm of a previous Akero Phase 2 study

Exclusion Criteria:

• Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results, including but not limited to: alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis [PBC], primary sclerosing cholangitis [PSC], autoimmune hepatitis), drug induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency

• Type 1 or unstable Type 2 diabetes

A reduced list of inclusion and exclusion criteria apply to participants in the open-label rollover extension.

Other inclusion and exclusion criteria may apply.

Non-Invasively Diagnosed NASH/MASH and NAFLD/MASLD

If you have  NASH/MASH or NAFLD/MASLD, you may qualify for one of our research studies.

Qualified volunteers may receive at no cost:

• investigational medication
• study-related care from a local doctor
• possible compensation

Health insurance isn’t required to participate.
Ask your doctor or contact our clinic for more information.

Or sign up below and we will contact you!

Study Information below is from Clinicaltrials.gov

Inclusion Criteria:

Main Study Only:

• Males and non-pregnant, non-lactating females between 18 – 80 (between 19-80 in the Republic of Korea) years of age inclusive, on the day of signing informed consent

• Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes

• Suspected or confirmed diagnosis of NASH/MASH or NAFLD/MASLD or non-invasively diagnosed NASH/MASH or NAFLD/MASLD

Open-Label Rollover

• Prior participation in the placebo arm of a previous Akero Phase 2 study

Exclusion Criteria:

• Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results, including but not limited to: alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis [PBC], primary sclerosing cholangitis [PSC], autoimmune hepatitis), drug induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency

• Type 1 or unstable Type 2 diabetes

A reduced list of inclusion and exclusion criteria apply to participants in the open-label rollover extension.

Other inclusion and exclusion criteria may apply.