Overview
Principal investigator
Eligibility criteria
Inclusion Criteria:
* Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) ≥4 with a score ≥1 point in each component (steatosis, ballooning, and lobular inflammation) AND NASH clinical research network (CRN) fibrosis score of Stage 2 or 3
* No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM with an A1C ≤9% that is controlled by diet or stable doses of antihyperglycemic agents (AHAs)
* Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive)
Exclusion Criteria:
* History of liver disease other than NASH
* History or evidence of cirrhosis
* History of pancreatitis
* History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy
* History of a bariatric surgical procedure ≤5 years before study entry, or a known clinically significant gastric emptying abnormality
* Has significant systemic or major illnesses, including recent events (≤6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack
* Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) ≥4 with a score ≥1 point in each component (steatosis, ballooning, and lobular inflammation) AND NASH clinical research network (CRN) fibrosis score of Stage 2 or 3
* No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM with an A1C ≤9% that is controlled by diet or stable doses of antihyperglycemic agents (AHAs)
* Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive)
Exclusion Criteria:
* History of liver disease other than NASH
* History or evidence of cirrhosis
* History of pancreatitis
* History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy
* History of a bariatric surgical procedure ≤5 years before study entry, or a known clinically significant gastric emptying abnormality
* Has significant systemic or major illnesses, including recent events (≤6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack
For Referring Providers
Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.