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

NCT05211284 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: SARO.20.001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Nonalcoholic Fatty Liver Disease

Keywords

Saroglitazar Magnesium; Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Hepatic Fat Content Measured by MRI Proton Density Fat Fraction (MRI PDFF)

  Change from baseline in hepatic fat content

  Week 24/EOT

Secondary Outcomes (15)

• To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Reduction of Hepatic Fat Content as Measured by MRI PDFF.

  Week 24/EOT

• To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in FibroScan®/VCTE .

  Week 24/EOT

• To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in FibroScan®/VCTE

  Week 24/EOT

• To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in FibroScan®/Vibration-controlled Transient Elastography (VCTE).

  Week 24/EOT

• To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis

  Week 24/EOT

Other Outcomes (1)

• Number of Participants Experiencing Adverse Events After Consuming Saroglitazar Magnesium Compared to Placebo

  From baseline to Week 28

Study Arms (2)

Saroglitazar Magnesium 4 mg

EXPERIMENTAL

Saroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks)

Drug: Saroglitazar Magnesium 4 mg

Placebo Arm

PLACEBO COMPARATOR

Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks).

Drug: Placebo

Interventions

Saroglitazar Magnesium 4 mg DRUG

Subjects randomized to Saroglitazar Magnesium 4 mg arm will receive Saroglitazar Magnesium 4 mg treatment until the duration of treatment (24 weeks).

Saroglitazar Magnesium 4 mg

Placebo DRUG

Subjects randomized to Placebo arm will receive Placebo treatment until the duration of treatment (24 weeks).

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years of age) with documented HIV.
• 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
• Hepatic fat fraction ≥8% by MRI-PDFF
• ALT level ≥31 U/L in men and ≥19 U/L in women at Visit 1 and 2
• 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).
• 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.
• Willingness to participate in the study.

You may not qualify if:

• 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).
• 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).
• History of liver transplant.
• Liver biopsy or radiologic imaging consistent with the clinical presence of cirrhosis or portal hypertension at screening.
• 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.
• 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').
• Uncontrolled T2DM, defined as HbA1c \>9.5% at screening.
• Any of the following laboratory values at screening:
• ALT or AST \>250 U/L
• Total bilirubin \>1.5 mg/dL and direct bilirubin \> 0.5 mg/dL (unless due to Gilbert's disease or atazanavir use per the opinion of the site investigator)
• Platelet count \<150,000/mm3
• Estimated glomerular filtration rate (e-GFR) \<60 mL/min/1.73m2 using the chronic kidney disease-epidemiology collaboration (CKD-EPI) equation (Refer Appendix 6 of protocol for 'CKD-EPI Calculator')
• International normalized ratio (INR) \>1.3.
• Albumin \< 3.6 g/dL

Sponsors & Collaborators

• Zydus Therapeutics Inc.: lead

Study Sites (8)

Zydus US004

Birmingham, Alabama, 35294-2050, United States

Location

Zydus US005

La Jolla, California, 92037, United States

Location

Zydus US006

San Francisco, California, 94143, United States

Location

Zydus US002

Indianapolis, Indiana, 46202, United States

Location

Zydus US003

Baltimore, Maryland, 21287, United States

Location

Zydus US001

Durham, North Carolina, 27710, United States

Location

Zydus US007

Houston, Texas, 77030, United States

Location

Zydus US008

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

saroglitazar

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr Deven Parmar
• Organization: Zydus Therapeutics Inc.

dparmar@zydustherapeutics.com

7324050886

Study Officials

• Deven V Parmar

  Zydus Therapeutics Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This phase 2a study is a randomized, placebo-controlled, double-blind, parallel arm trial to evaluate the safety and efficacy of Saroglitazar Magnesium 4 mg compared with placebo in biopsy-proven NAFLD in people living with HIV (PLWH). Eligible participants will be randomized in a 1:1 ratio to receive Saroglitazar Magnesium 4 mg or placebo.

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: January 27, 2022
• Study Start: December 8, 2022
• Primary Completion: October 2, 2023
• Study Completion: October 2, 2023
• Last Updated: September 2, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-08

Locations

US (8)