Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis

Melinta Therapeutics, Inc.10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nonalcoholic Steatohepatitis

Interventions

solithromycinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Case Western University Hospitals

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

To evaluate effects on hepatic histology in patients with NASH

Using the Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS)

Time frame: 13 weeks

Secondary Outcomes

Changes in Steatosis on liver biopsy

Graded from 0 to 3

Time frame: 13 weeks

Changes in hepatocellular ballooning score on liver biopsy

Graded from 0 to 2

Time frame: 13 weeks

Changes in inflammation on liver biopsy

Graded from 0 to 3

Time frame: 13 weeks

Data from ClinicalTrials.gov

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