Trials / Unknown
UnknownNCT04880187
Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of AXA1125 in Subjects With Non Cirrhotic, Non Alcoholic Steatohepatitis and Fibrosis (EMMPACT)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 273 (estimated)
- Sponsor
- Axcella Health, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis (NASH). as well as the safety and tolerability of AXA1125. Subjects will take one of two different doses of AXA1125 or a placebo twice daily, and a liver biopsy will be done at the beginning and end of the 48-week study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AXA1125 | AXA1125 administered BID with or without food |
| DRUG | Placebo | Matching Placebo administered BID with or without food |
Timeline
- Start date
- 2021-05-07
- Primary completion
- 2023-09-01
- Completion
- 2023-10-01
- First posted
- 2021-05-10
- Last updated
- 2022-09-08
Locations
75 sites across 7 countries: United States, Australia, Canada, France, Poland, Puerto Rico, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04880187. Inclusion in this directory is not an endorsement.