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

March 20, 2017 updated by: Melinta Therapeutics, Inc.

An Open Label, Proof of Principle Study to Evaluate the Efficacy and Safety of Solithromycin for the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be administered solithromycin for 13 weeks with regular safety visits and liver biopsies at baseline and after treatment.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solithromycin
Solithromycin 200 mg PO QD for 1 week, followed by 200 mg PO TIW for 12 weeks
Drug: solithromycin
Other Names:
  • CEM-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate effects on hepatic histology in patients with NASH
Time Frame: 13 weeks
Using the Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS)
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Steatosis on liver biopsy
Time Frame: 13 weeks
Graded from 0 to 3
13 weeks
Changes in hepatocellular ballooning score on liver biopsy
Time Frame: 13 weeks
Graded from 0 to 2
13 weeks
Changes in inflammation on liver biopsy
Time Frame: 13 weeks
Graded from 0 to 3
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melinta Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

January 27, 2017

Study Completion (Actual)

February 28, 2017

Study Registration Dates

First Submitted

July 1, 2015

First Submitted That Met QC Criteria

July 28, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE01-205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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