Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The study includes 52 weeks, double-blind treatment period. Clinic visits will occur at
Randomization and every four weeks from Week 4 through Week 52 and through End of Study
period. The study includes a post-dosing study visit that will occur 4 weeks after the last
dose of study drug. This visit represents the End-of-Study Visit (Week 56 Visit). Three
hundred thirty-seven subjects will be enrolled into five treatment arms and there will be an
equal distribution of males and females in each treatment arm. Subjects will be stratified by
gender, fibrosis stage, and diabetes status.
Phase
Phase 2
Funding Agency/Sponsor
Industry
Disease
Non-Alcoholic Steatohepatitis (NASH)
Enrollment Eligibility
Inclusion Criteria:
1. Provide a personally signed and dated informed consent document indicating that the
subject (or a legally acceptable representative) has been informed of all pertinent
aspects of the study and is willing and able to participate;
2. Have a histologically-confirmed diagnosis of NASH on a liver biopsy performed during
screening or within 6 months before screening; for this study, confirmation requires:
1. NASH Clinical Research Network (CRN) fibrosis stage 1 to stage 3 and
2. NASH activity score (NAS) of ≥4 with at least a score of 1 in each of the
following NAS components: ballooning degeneration (score = 0-2), lobular
inflammation (score = 0-3) and steatosis (score = 0-3); (c) F1 subjects must have
at least one of these risk factors: type 2 diabetes, body mass index of ≥ 30 mg/
m2, and/ or alanine aminotransferase > 1.5 x ULN
3. Have a screening MRI-PDFF with ≥ 8% liver fat fraction;
4. Male and females be 18 to 75 years of age, inclusive, at screening;
Exclusion Criteria:
1. Are unwilling to undergo the required liver biopsy procedures or have any condition
that would prevent obtaining a liver biopsy as part of this clinical protocol
2. Have evidence of current or history of excessive alcohol consumption of more than 20 g
per day for women and 30 g per day for men, on average, within 6 months before the
qualifying liver biopsy and up to randomization, or are unable to provide a reliable
estimate of alcohol consumption during this period;
3. Treatment with medications for the purpose of weight loss within 6 months prior to
qualifying liver biopsy, unless approved after consultation with the medical monitor.
These include drugs approved for weight loss (e.g. orlistat, bupropion/naltrexone,
phentermine-topiramate, phentermine, lorcaserin), as well as drugs used off-label,
herbal preparations and dietary supplements marketed for control of body weight or
appetite;
4. TSH outside central laboratory reference range;
5. Free T4 outside central laboratory reference range;
6. Cardiac troponin I (cTnI) and creatine kinase MB isoenzyme (CK-MB) > Upper Limit of
Normal (ULN) at screening;
7. Serum albumin < 3.5 g/dL;
8. International normalized ratio (INR) > 1.3;
9. Total bilirubin > 1.2 X ULN (except in presence of Gilbert synd
10. Strong or moderate inhibitors or inducers of CYP3A4 are prohibited during the study
period
11. Drugs that may affect liver fat content or are associated with nonalcoholic fatty
liver disease (NAFLD) are prohibited during the 3 month period prior to the baseline
liver biopsy and up to the end of treatment