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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Fatty Liver Disease

In brief

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

Key facts

Study ID

NCT05211284

Run by

Zydus Therapeutics Inc.

People needed

4

Starts

2022-12-08

Expected to finish

2023-10-02

Last updated by the study team

2025-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• History of malignancy in the past 5 years and/or active neoplasm with the exception of superficial, non-melanoma, skin cancer.
• Unstable cardiovascular disease, including:
• Unstable angina, (i.e., new or worsening symptoms of coronary heart disease) and/or acute myocardial infarction within the 3 months preceding screening
• Acute coronary syndrome or coronary artery intervention within the 3 months preceding screening,
• Heart failure of New York Heart Association (NYHA) class (III-IV) or worsening congestive heart failure within the 6 months preceding screening.
• History of (within 3 months preceding screening) or current unstable cardiac dysrhythmias.
• Uncontrolled hypertension (systolic blood pressure [SBP] >155 mmHg and/or diastolic blood pressure [DBP] >95 mmHg) at screening.
• Stroke or transient ischemic attack within the 6 months preceding screening.
• Unstable pulmonary disease (based upon site investigator's evaluation) at screening.
• Use of drugs that are known CYP2C8 inhibitors/substrates (Refer Appendix 2 of protocol for the 'List of Known CYP2C8 Inhibitors/Substrates') in the last 28 days prior to screening.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.