| Trial ID: | L0254 |
| Source ID: | NCT05211284
|
| Associated Drug: |
Saroglitazar Magnesium
|
| Title: |
Saroglitazar Magnesium 4 mg for NASH in People Living With HIV in the US
|
| Acronym: |
SARONAPLUS
|
| Status: |
Not yet recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: Saroglitazar Magnesium 4 mg|Drug: Placebo
|
| Outcome Measures: |
To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo in improving NASH, defined as an improvement of at least 2 points (without worsening of fibrosis) in the NAFLD activity score (NAS)|To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on resolution of steatohepatitis and no worsening of liver fibrosis on the NASH Clinical Research Network (CRN) Histologic Scoring System|To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on improvement in fibrosis assessed by NASH CRN Histologic Scoring System with no worsening of steatohepatitis|To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on changes in histological scores|To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on changes in Liver Stiffness Measurement (LSM), Continuous Controlled Attenuation Parameter (CAP) and Fibroscan-AST (FAST) score, as measured by FibroScan??/VCTE|To evaluate the effects of Saroglitazar Magnesium 4 mg compared with Placebo on changes in non invasive markers of fibrosis and steatosis|To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on body weight|To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on changes in 10-year Atherosclerotic cardiovascular disease (ASCVD) risk score (ACC/AHA Guideline on the Assessment of Cardiovascular Risk, 2013)|To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on changes in health-related quality of life scores measured by SF-36 Questionnaire|To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on body mass index (BMI)|To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on hip circumference|To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on minimum waist circumference
|
| Sponsor/Collaborators: |
Zydus Therapeutics Inc.
|
| Gender: |
All
|
| Age: |
18 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
160
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
April 1, 2022
|
| Completion Date: |
March 1, 2025
|
| Results First Posted: |
--
|
| Last Update Posted: |
January 28, 2022
|
| Locations: |
--
|
| URL: |
https://ClinicalTrials.gov/show/NCT05211284
|
