A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes

Exclusion Criteria

• •The patient has a history of chronic liver disease other than NASH eg, chronic or acute hepatitis, autoimmune, viral (A, B, C), genetic hepatitis, drug induced hepatotoxicity, Wilson's disease, alcoholic liver diseases, or any other non-NASH active liver disease.
• •The patient has active cancer or a history of a malignant disease (except basal cell carcinoma of the skin) within 5 years prior to screening or any history of bladder cancer.
• •The patient had an unstable metabolic condition (ie, with a history of weight loss or weight gain of \>5 kg within 24 weeks prior to screening)
• •The patient has a history of bariatric surgery within 5 years prior to screening.
• •The patient has received mercaptopurine or azathioprine previously within 1 year prior to screening
• •The patient has taken within 7 days prior to the first dose of study drug (or is anticipated to take during the study) anticholinergic or other drugs known to affect gastrointestinal (GI) motility, proton-pump inhibitors, or other drugs known to affect gastric acidity or use of allopurinol.
• •The patient has received oral antibiotics within the last 4 weeks prior to randomization (day 1).
• •The patient has received treatment within the last 30 days with any drugs known to induce or inhibit endogenous hepatic drug metabolism (eg, barbiturates, phenothiazines, cimetidine, carbamazepine) or anti-coagulant therapy (eg, heparin, warfarin, acenocoumarol).
• •The patient has Type 1 Diabetes Mellitus (T1DM) or poorly controlled T2DM
• •The patient has a body mass index (BMI) \<25 kg/m2.
• •The patient has a history of diabetic gastroparesis or has had gastric bypass surgery within the last 5 years.
• •The patient has a history of pancreatitis.
• •The patient has a history of persistent intestinal obstruction, bowel perforation, uncontrolled GI bleed or abdominal abscess or infection or toxic megacolon or inflammatory bowel disease (IBD)
• •The patient has a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, unstable angina, myocardial infarction, transient ischemic events, or stroke within 24-weeks prior to screening.
• •The patient is classified as Class II-IV via New York Heart Association
• •The patient has a history of drug abuse (defined as illicit drug use) or a history of excessive alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic drinks per day for women or 3 alcoholic drinks per day for men) within 1 year prior to the screening visit.
• •* Additional criteria apply, please contact the investigator for more information