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

Completed · Phase 2

Conditions studied: Nonalcoholic Steatohepatitis

In brief

The purpose of this study is to evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis.

Key facts

Study ID

NCT02510599

Run by

Melinta Therapeutics, Inc.

People needed

10

Starts

2015-12-01

Expected to finish

2017-02-28

Last updated by the study team

2017-03-21

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic evidence of NASH based on liver biopsy obtained within 180 days
• NAS> or = 5
• Able to swallow capsules intact

You may not qualify if…

• 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

Where it is running

• Case Western University Hospitals — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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