| Trial ID: | L0325 |
| Source ID: | NCT05011305
|
| Associated Drug: |
Saroglitazar Magnesium
|
| Title: |
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis
|
| Acronym: |
NASH
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis|Fibrosis
|
| Interventions: |
Drug: Saroglitazar Magnesium 2 mg|Drug: Saroglitazar Magnesium 4 mg|Drug: Placebo
|
| Outcome Measures: |
Resolution of steatohepatitis with no worsening of fibrosis|Improvement in liver fibrosis with no increase in NAS for ballooning, inflammation or steatosis|2 points improvement in NAS|Improvement in steatosis, ballooning, inflammation and fibrosis from liver biopsy|Decrease in SAF score on liver biopsy|Histological score changes in steatosis, ballooning, inflammation, and fibrosis|Change in liver enzyme parameters including (ALT, AST, ALP, GGT, total bilirubin, albumin)|Change in non-invasive markers of steatosis|Change in n lipid parameters including (TG, LDLC, TC, HDL-C, non-HDL-C, VLDL-C|Change in body weight (any change from baseline)|Change in insulin resistance marker, HOMA-IR|Change in inflammatory markers including (CK-18 [M30], IL-6, CRP)|Change in glucose homeostasis markers including (HbA1c, FPG)|Change from baseline in non-invasive markers of fibrosis
|
| Sponsor/Collaborators: |
Zydus Therapeutics Inc.
|
| Gender: |
All
|
| Age: |
18 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
240
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
August 18, 2021
|
| Completion Date: |
December 2023
|
| Results First Posted: |
--
|
| Last Update Posted: |
August 19, 2021
|
| Locations: |
Zydus US014, Los Angeles, California, United States|Zydus US012, Panorama City, California, United States|Zydus US003, Lakeland, Florida, United States|Zydus US004, Winter Park, Florida, United States|Zydus US011, Hermitage, Tennessee, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT05011305
|
