The purpose of this study is to evaluate the effects of solithromycin on hepatic histology
and biomarkers in patients with nonalcoholic steatohepatitis.
Patients will be administered solithromycin for 13 weeks with regular safety visits and
liver biopsies at baseline and after treatment.
- Histologic evidence of NASH based on liver biopsy obtained within 180 days
- NAS> or = 5
- Able to swallow capsules intact
- Symptoms of acute liver disease
- Cirrhosis on liver biopsy
- Positive HIV or Hepatitis tests
- Primary Biliary Cirrhosis
- Poorly controlled diabetes with HgA1C >8.5%
- ALT >4-fold upper limit of normal
- QTcF >450 msec
- CrCl <40 mL/min