This trial is examining the effectiveness of LIK006 in obese patients with non-alcoholic steatohepatitis (NASH; fatty liver not caused by alcohol consumption).
The main outcomes to be measured will be the change in liver enzymes and liver and body fat at week 12.
The details
Nonalcoholic steatohepatitis (NASH) is liver inflammation and damage caused by a buildup of fat in the liver. It is commonly seen in overweight or obese patients. As NASH progresses it can cause liver scarring and can lead to cirrhosis or liver cancer. LIK066 is a sodium glucose transporter type 1 and type 2 (SGLT 1/2) inhibitor. It is a drug currently being developed for the treatment of type 2 diabetes. Its safety and effectiveness in patients with NASH are unknown.
The purpose of this study is to assess the effects of LIK066 on the fatty liver in patients with NASH. The main outcomes will be measured as the change in liver enzymes blood levels at week 12 following treatment.
Who are they looking for?
110 participants are being recruited. Patients must have confirmed NASH on liver biopsy (tissue sample) and ALT (liver enzyme) >50 IU/L (males) and >35 IU/L (females). In the absence of tissue samples, patients can also have high ALT levels >50 IU/L (males) and >35 IU/L (females), a body mass index (BMI) over 27 kg/m2, and a diagnosis of type 2 diabetes (T2D). Patients should not have more than 150kg (330lb) body weight.
Patients will no be included if they have other concurrent liver diseases including liver cirrhosis, heart problems or a history of significant alcohol consumption. Patients who cannot undergo MRI (imaging test), women of childbearing potential who do not wish to use birth control and patients who have used GLP-1 agonists (diabetes medications), SGLT2 inhibitors (diabetes medications), or weight loss drugs cannot participate.
How will it work
There will be three groups in the study. Groups 1 and 2 will receive LIK066 at 2 different doses orally once a day for 12 weeks. The last group will receive a placebo orally once a day for 12 weeks. Liver enzymes, body weight, and liver fat will be evaluated at the beginning of the study and after 12 weeks of treatment.
