Nonalcoholic Steatohepatitis
Conditions
Keywords
NASH, Liver disease
Brief summary
The purpose of this study is to evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis.
Detailed description
Patients will be administered solithromycin for 13 weeks with regular safety visits and liver biopsies at baseline and after treatment.
Interventions
DRUGsolithromycin
Sponsors
Melinta Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histologic evidence of NASH based on liver biopsy obtained within 180 days * NAS\> or = 5 * Able to swallow capsules intact
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate effects on hepatic histology in patients with NASH | 13 weeks | Using the Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Steatosis on liver biopsy | 13 weeks | Graded from 0 to 3 |
| Changes in hepatocellular ballooning score on liver biopsy | 13 weeks | Graded from 0 to 2 |
| Changes in inflammation on liver biopsy | 13 weeks | Graded from 0 to 3 |
Countries
United States
Outcome results
None listed