Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis (EVIDENCES VI)
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|ClinicalTrials.gov Identifier: NCT03863574|
Recruitment Status : Completed
First Posted : March 5, 2019
Last Update Posted : December 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non Alcoholic Steatohepatitis||Drug: Saroglitazar Magnesium 2mg Drug: Saroglitazar Magnesium 4mg Drug: Placebos||Phase 2|
Patients clinically suspected of NASH will be invited for a screening programme for inclusion in the study. Patients will be screened according to the inclusion and exclusion criteria. Clinical evaluation will be conducted for baseline characteristics and anthropometry measurements such as body weight and height.
After clinical evaluations, all baseline safety and efficacy parameters will be recorded as per Visit Schedule. All laboratory collections will be performed following overnight fasting (at least 8 hrs).
Following confirmation of all clinical and laboratory inclusion and exclusion criteria, patients will continue into the screening period. During the screening period liver biopsy will be performed. However, if a biopsy was performed within 6 months the slides and biopsy material, or block, must be made available for baseline documentation. Such Patients, whose historical biopsy report is available, should not use medication suspected of having an effect on NASH from the 3 months prior to the screening.
Liver biopsy will be performed to confirm the diagnosis of NASH and record a baseline NAFLD Activity Score. The histological evidence of NASH is defined as NAS ≥ 4 with a minimum score of 1 for all of its three components [steatosis, hepatocyte ballooning and lobular inflammation].
Following confirmation of inclusion/exclusion criteria and upon histological confirmation of NASH by liver biopsy, patients will be enrolled into the study.
Eligible patients will be randomly assigned to receive Saroglitazar Magnesium 2 mg or 4 mg or placebo in a 2:2:1 ratio for 24 weeks.
Upon completion of 24 weeks of treatment, liver biopsy will be performed and the NAFLD Activity Score recorded.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium 2 mg and 4 mg in Patients With Non-alcoholic Steatohepatitis|
|Actual Study Start Date :||June 12, 2019|
|Actual Primary Completion Date :||July 2, 2020|
|Actual Study Completion Date :||October 30, 2020|
Experimental: Saroglitazar Magnesium 2 mg
Saroglitazar Magnesium 2 mg tablet orally once daily in the morning before breakfast for 24 weeks.
Drug: Saroglitazar Magnesium 2mg
Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily for 24 weeks.
Experimental: Saroglitazar Magnesium 4 mg
Saroglitazar Magnesium 4 mg tablet orally once daily in the morning before breakfast for 24 weeks.
Drug: Saroglitazar Magnesium 4mg
Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily for 24 weeks.
Placebo Comparator: Placebo
Placebo tablet orally once daily in the morning before breakfast for 24 weeks.
Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks.
- NAS Score (NAFLD Activity Score) [ Time Frame: Baseline to Week 24 ]The primary endpoint is to assess the changes in NAFLD Activity Score (NAS) at week 24 from baseline and with no worsening of fibrosis in NASH patients.
- To evaluate the percentage of responders in the treatment groups. [ Time Frame: Baseline to Week 24 ]Responder is defined as a decrease from baseline of at least 2 points spread across at least 2 of the NAS components [steatosis, hepatocyte ballooning, and lobular inflammation] with no worsening of fibrosis.
- Percentage of responders defined by the disappearance of steatohepatitis. [ Time Frame: Baseline to Week 24 ]Percentage of responders defined by the disappearance of steatohepatitis.
- Changes in the stage of steatosis, lobular inflammation and ballooning. [ Time Frame: Baseline to Week 24 ]Changes in the stage of steatosis, lobular inflammation and ballooning by evaluating the NAS Score (NAFLD Activity Score)
- Changes in the stage of fibrosis. [ Time Frame: Baseline to Week 24 ]Changes in the stage of fibrosis by evaluating the Fibrosis stages
- Changes in the liver function tests. [ Time Frame: Baseline to Week 24 ]Liver function tests include ALT, AST, ALP, direct bilirubin, GGT, total proteins and albumin.
- Changes in the lipid profile. [ Time Frame: Baseline to Week 24 ]Evaluation of Lipid profile parameters
- Changes in the glycemic control and insulin resistance. [ Time Frame: Baseline to Week 24 ]Evaluation of glycemic control and insulin resistance.
- To assess incidence of Adverse Events of Saroglitazar Magnesium 2 mg and 4 mg in patients with non-alcoholic steatohepatitis. [ Time Frame: Baseline to Week 24 ]Safety will be assessed during the study period through the reporting of AEs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863574
|United States, Mississippi|
|Southern Therapy and Advanced Research (STAR) LLC|
|Jackson, Mississippi, United States, 39216|
|United States, Tennessee|
|Germantown, Tennessee, United States, 38138|
|Digestive Health Research|
|Hermitage, Tennessee, United States, 37076|
|United States, Texas|
|American Research Corporation|
|San Antonio, Texas, United States, 78215|
|Clinical Trials of Texas, Inc.|
|San Antonio, Texas, United States, 78229|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Study Director:||Deven V Parmar, MD,FACP,FCP||Zydus Discovery DMCC|