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Do you have NonAlcoholic SteatoHepatitis (NASH) that is not responding?
About NASH
NASH stands for nonalcoholic steatohepatitis. It is the most severe form of nonalcoholic fatty liver disease (NAFLD). NAFLD is caused by an abnormal buildup of fat in the liver and is not caused by alcohol abuse. When this buildup of liver fat starts to cause inflammation and damage to the liver, it is then referred to as NASH. NASH eventually can lead to scarring of the liver, which may lead to a potentially life-threatening condition called cirrhosis. The cause of NASH is not fully understood, but it has been noted that NASH patients usually also have type 2 diabetes, insulin resistance, high blood pressure, and elevated cholesterol. There are currently no approved drugs for the treatment of NASH. Weight loss is the only therapy with reasonable scientific evidence suggesting that it is a safe, beneficial approach to potentially improve quality of life in NASH patients.
HTD1801
HTD1801, also known as berberine ursodeoxycholate, is a new drug formed between berberine (BBR) and ursodeoxycholic acid (UDCA) and is currently being developed as an oral treatment for NASH. HTD1801 is being tested as a study drug and has not been approved by the US Food and Drug Administration (FDA) or other government health authorities for the treatment of any disease.
The Centricity NASH Study
NASH is a serious, chronic liver disease with a large unmet medical need and no approved therapy. The Centricity NASH Study is being done to see how safe HTD1801 will be for subjects who have a combination of NASH and type 2 diabetes (or pre-diabetes). The study will check whether HTD1801 is effective in improving symptoms of NASH (reduction of liver inflammation or scarring, overall liver health) and also improving blood pressure, body weight, and cholesterol or triglycerides.
Up to 210 people between the ages of 18 and 75 years of age who have been diagnosed with NASH and type 2 diabetes (or pre-diabetes) will be enrolled into the study from up to 90 study sites across US, Mexico and Hong Kong. The study is randomized so subjects will be randomly (like a flip of a coin) assigned to receive either HTD1801 or placebo (sugar pill). Neither the subject nor the clinic staff will know if HTD1801 or placebo is assigned.
Subjects will complete study screening for up to 12 weeks (3 months) to see if certain requirements to participate in the study are met. Subjects who meet all screening requirements will be enrolled. The first 105 enrolled subjects will receive study drug treatment for 60 weeks (14 months). The remaining 105 enrolled subjects will receive study drug treatment for 48 weeks (11 months). Subjects will complete a follow-up visit 4 weeks (1 month) after they have completed their assigned study drug treatment. Total duration of study participation is 64 or 72 weeks (15 to 18 months).
Enrollment begins November 2022.
Eligible participants will need to meet the following requirements*:
- You are between 18 and 75 years old
- You have a confirmed diagnosis of NASH
- You have a confirmed diagnosis of type 2 diabetes (T2DM) for at least 6 months or confirmed to have pre-diabetes
* Additional criteria will apply.