Trials / Completed
CompletedNCT02510599
Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
An Open Label, Proof of Principle Study to Evaluate the Efficacy and Safety of Solithromycin for the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Melinta Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | solithromycin |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2017-01-27
- Completion
- 2017-02-28
- First posted
- 2015-07-29
- Last updated
- 2017-03-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02510599. Inclusion in this directory is not an endorsement.