| Trial ID: | L0287 |
| Source ID: | NCT02574325
|
| Associated Drug: |
ARI-3037MO
|
| Title: |
A Study to Assess ARI-3037MO on Hepatic Fat Metabolism in Patients With Dysglycemia and Evidence of Hepatic Steatosis
|
| Acronym: |
--
|
| Status: |
Unknown status
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: Placebo|Drug: ARI-3037MO
|
| Outcome Measures: |
Efficacy as measured by change in intra hepatic fat content|Efficacy as measured by change in plasma ALT levels|Efficacy as measured by change in plasma TG levels|Safety as measured by the occurrence of flushing (number of episodes) and itching (number of episodes)|Safety as measured by effect of ARI-3037MO on on glycemic control|Safety as measured by effect of ARI-3037MO on serum bilirubin, alkaline phosphatase, Prothrombin time and plasma albumin levels|Safety as measured by effect of ARI-3037MO on gastrointestinal systems; episodes of nausea, vomiting and diarrhea
|
| Sponsor/Collaborators: |
Arisaph Pharmaceuticals Inc
|
| Gender: |
All
|
| Age: |
18 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
11
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
October 2015
|
| Completion Date: |
December 2016
|
| Results First Posted: |
--
|
| Last Update Posted: |
August 8, 2016
|
| Locations: |
Gastroenterology & Hepatology CRU, St Louis University, St Louis, Missouri, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT02574325
|
