Saroglitazar Magnesium 4 mg for NASH in People Living With HIV in the US
Saroglitazar Magnesium 4 mg for NASH in People Living with HIV in the US
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis (NASH) in People Living With Human Immunodeficiency Virus (HIV) in the US
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis (NASH) in People Living with Human Immunodeficiency Virus (HIV) in the US
Nonalcoholic Steatohepatitis, Saroglitazar Magnesium, Fatty Liver, Non-alcoholic Fatty Liver Disease, Saroglitazar Magnesium 4 mg
You can join if…
Open to people ages 18 years and up
- Adults (≥18 years of age) with documented HIV.
- Histologic confirmation of NASH from liver biopsy within 6 months prior to screening or planned clinical biopsy in patients with suspected NASH pending confirmation of liver biopsy criteria including a NAS ≥4 (with at least one-point each for steatosis, lobular inflammation, and ballooning).
- HIV-1 RNA <50 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 and undergo an EOT liver biopsy
You CAN'T join 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.
- Participants with prior acute HBV infection that is resolved but currently do not have hepatitis B surface antigen (HBsAg) or detectable HBV Deoxyribonucleic acid (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 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 dose [for ≥3 months] of feminizing hormonal therapy), within 3 months prior to screening or historical liver biopsy until time of randomization or anticipated use of medications that cause significant changes in weight during the study period; (Refer Appendix 7 for 'List of Medications').
- Uncontrolled type 2 diabetes mellitus, 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 for 'CKD-EPI Calculator').
- International normalized ratio (INR) >1.3.
- Albumin < 3.6 g/dL
10. Participants with child-bearing potential (pregnancy or inability or unwilling to
practice contraception for the study duration) or breast-feeding.
11. 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 6 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 mm Hg and/or diastolic blood pressure [DBP] >95 mm Hg) 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 for the 'List of Known CYP2C8 inhibitors/substrates') in the last 28 days preceding screening.
- History of severe illness or any other conditions (such as poorly controlled psychiatric disease, active gastrointestinal conditions that might interfere with drug absorption, etc.) that require systemic treatment/or hospitalization, until participant either completes therapy or is clinically stable on therapy as per the opinion of the site investigator, for at least 7 days prior to screening.
- Use of other PPAR agonists (fibrates, thiazolidinediones, telmisartan) within 6 months prior to screening or historical liver biopsy until time of randomization.
- Use of unstable doses of sodium-glucose cotransporter-2 (SGLT2) inhibitors (e.g. canagliflozin, empagliflozin, dapagliflozin, etc.) or glucagon-like peptide (GLP)-1 agonists (e.g. exenatide, liraglutide, lixisenatide, etc.) within 6 months prior to screening or historical liver biopsy until time of randomization.
- Use of pentoxifylline, ursodeoxycholic acid, antioxidants such as vitamin E (>200 IU/day), glutathione, orlistat, betaine, incretin mimetics or non-prescribed complementary alternative medications within 6 months prior to screening or historical liver biopsy until time of randomization.
- Known allergy, sensitivity or intolerance to the study medication or formulation ingredients.
- History of any known bleeding disorder or coagulopathy.
- Any condition that in the opinion of the site investigator, would compromise the participant's ability to participate in the study.
- Unstable doses of anti-diabetic agents, including sulfonylureas, biguanides or dipeptidyl peptidase-4 (DPP-4) inhibitors in the last 3 months prior to screening or historical liver biopsy until time of randomization.
- Unstable doses of lipid-lowering agents such as statins (e.g. simvastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin, etc.) in the last 3 months prior to screening or historical liver biopsy until time of randomization.
- Participant with weight change >5% within 6 months prior to screening or historical liver biopsy until time of randomization.
- History of bariatric surgery or currently undergoing evaluation for bariatric surgery.
- Participation in another interventional clinical study and/or receipt of any other investigational medication within 3 months prior to screening or historical liver biopsy .
- History of COVID-19 infection in the last 30 days prior to screening.
- Pregnancy-related exclusions, including:
- Pregnant/lactating female (including positive pregnancy test at screening)
Fertile women participants and their male counterparts or vice versa, not using effective contraceptive methods (such as an intra-uterine contraceptive device, other mechanical contraceptive methods like use of condom and diaphragm along with spermicide, or hormonal contraceptives that inhibit ovulation) throughout the study.
(Note: Enrolled females otherwise must be surgically sterilized for at least 24 weeks before screening; postmenopausal, defined as 52 weeks with no menses without an alternative medical cause; or following sexual abstinence).
- Zydus research site 6
not yet accepting patients
San Francisco California 94143 United States
- Zydus research site 5
not yet accepting patients
La Jolla California 92037 United States
- accepting new patients at some sites,
but this study is not currently recruiting here
- Start Date
- Completion Date
- Zydus Therapeutics Inc.
- Phase 2 research study
- Study Type
- Expecting 160 study participants
- Last Updated