Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
- Registration Number
- NCT02510599
- Lead Sponsor
- Melinta Therapeutics, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Solithromycin solithromycin Solithromycin 200 mg PO QD for 1 week, followed by 200 mg PO TIW for 12 weeks
- Primary Outcome Measures
Name Time Method To evaluate effects on hepatic histology in patients with NASH 13 weeks Using the Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS)
- Secondary Outcome Measures
Name Time Method Changes in inflammation 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 Steatosis on liver biopsy 13 weeks Graded from 0 to 3
Trial Locations
- Locations (1)
Case Western University Hospitals
🇺🇸Cleveland, Ohio, United States