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Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US

NCT05211284•Zydus Therapeutics Inc.

View on ClinicalTrials.gov

Summary

Saroglitazar Magnesium 4 mg for NAFLD in People Living with HIV in the US

Detailed Description

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Saroglitazar Magnesium for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in People Living with Human Immunodeficiency Virus (HIV) in the US The four participants enrolled on version 3.0 protocol were terminated as the primary endpoint was revised from biopsy to an imaging-based approach in the subsequent protocol version 4.0. These changes were done due to recruiting challenges pertaining to biopsy. However, no participants were enrolled in the revised protocol (version 4.0) as, by then the decision to terminate the study was taken by the Sponsor considering the modifications in the internal R\&D focus and a revised commercialization strategy. The version 3.0 protocol is dated 02/Jun/2022.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adults (≥18 years of age) with documented HIV.
•2. Documented diagnosis of NAFLD established by imaging (ultrasound, CT scan or MRI) or liver biopsy within 6 months before screening, based on American Association for the Study of Liver Disease \[AASLD\] criteria
•3. Hepatic fat fraction ≥8% by MRI-PDFF
•4. ALT level ≥31 U/L in men and ≥19 U/L in women at Visit 1 and 2
•5. HIV-1 RNA \<200 copies/mL for ≥6 months on ART (must have screening HIV-1 RNA value and one clinical care value within 6 months prior to screening and up to the randomization that meets the criteria).
•6. Stable ART regimen for ≥3 months prior to screening and stable up to the randomization and no active plans to change ART while on study.
•7. Willingness to participate in the study.

Exclusion Criteria

•1. History of significant alcohol consumption (defined as \>2 drinks/day on average for men, \>1 drinks/day on average for women) for at least 3 consecutive months (12 consecutive weeks) within 5 year before screening (Note 1: 1 drink =12 ounces of beer, 8-9 ounces of malt liquor, 4 ounces of wine or 1 ounce of spirits/hard liquor. Note 2: Use sex assigned at birth for alcohol consumption limits).
•2. History of other acute or chronic liver disease, including, but not limited to autoimmune, primary biliary cholangitis, Wilson's disease, alpha 1 antitrypsin deficiency, hemochromatosis, hepatitis B virus (HBV), and ongoing or recent (within the past 3 years) hepatitis C RNA positivity. (Exceptions: a. Participants with previously treated hepatitis C infection are eligible for consideration if their sustained virologic response was achieved more than 3 years prior to screening. The proportion of such participants in this trial will not exceed 25% of the study cohort. b. Participants with prior acute HBV infection that is resolved but currently do not have hepatitis B surface antigen (HBsAg) or detectable HBV DNA are eligible).
•3. History of liver transplant.
•4. Liver biopsy or radiologic imaging consistent with the clinical presence of cirrhosis or portal hypertension at screening.
•5. Participants whose Visit 2 ALT, AST, or alkaline phosphatase (ALP) values exceed their Visit 1 values by more than 50%.
•Note: These participants will be required to have a third value measured at-least one week after V2, to assess for a trend. If the third value shows a continued increase ≥10% compared to the Visit 2 values, the participant is considered ineligible for randomization.
•6. Ongoing use of steatogenic medications or supra-physiologic hormonal therapies (Exception: transgender women on stable (≥3 month) feminizing hormonal therapy not excluded), within 3 months prior to screening until time of randomization or anticipated use of medications that cause significant changes in weight during the study period (Refer Appendix 7 of protocol for 'List of Steatogenic Medications Or Supra-Physiologic Hormonal Therapies Or Medications That Cause Significant Weight Change').
•7. Uncontrolled T2DM, defined as HbA1c \>9.5% at screening.
•8. Any of the following laboratory values at screening:
•1. ALT or AST \>250 U/L
+31 more criteria

Locations (8)

Zydus US004

Birmingham, Alabama, United States

Zydus US005

La Jolla, California, United States

Zydus US006

San Francisco, California, United States

Zydus US002

Indianapolis, Indiana, United States

Zydus US003

Baltimore, Maryland, United States

Zydus US001

Durham, North Carolina, United States

Zydus US007

Houston, Texas, United States

Zydus US008

Richmond, Virginia, United States

Key Dates

Start Date

December 8, 2022

Primary Completion Date

October 2, 2023

Completion Date

October 2, 2023

Last Updated

September 2, 2025

Enrollment

ACTUAL participants

Conditions

Nonalcoholic Fatty Liver Disease

Interventions

Saroglitazar Magnesium 4 mg

DRUG

Placebo

DRUG

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ACTIVE_NOT_RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US

Inclusion Criteria

Exclusion Criteria

iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss

Phase 2b Study of GSK4532990 in Adults With NASH

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