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Saroglitazar Magnesium 4 mg for NAFLD in People Living with HIV in the US
Full 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
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Inclusion criteria
Exclusion criteria
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 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:
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 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 prior to screening.
History of severe illness or any other conditions that require systematic treatment/or hospitalization, until participant either completes therapy or is clinically stable on therapy as per the opinion of the investigator, for at least 7 days prior to screening (such as poorly controlled psychiatric disease, active gastrointestinal conditions that might interfere with drug absorption, etc.).
Use of thiazolidinediones or Telmisartan within 3 months prior to screening or until time of randomization.
Use of unstable doses of SGLT2 inhibitors (e.g. canagliflozin, empagliflozin, dapagliflozin, etc.), glucose-dependent insulinotropic polypeptide (GIP) and/or GLP-1 agonists (e.g. semaglutide, exenatide, liraglutide, lixisenatide, tirzepatide etc.) within 6 months prior to screening until time of randomization.
Use of pentoxifylline, ursodeoxycholic acid, antioxidants such as vitamin E (>200 IU/day), glutathione, orlistat, betaine, or non-prescribed complementary alternative medications within 6 months prior to screening 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 DPP-4 inhibitors in the last 3 months prior to screening until time of randomization.
Unstable doses of lipid lowering agents such as statins (e.g. simvastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin, etc.) or fibrates (clofibrate, Fenofibrate) in the last 3 months prior to screening until time of randomization.
Participant with weight change >5% within 6 months prior to screening 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.
History of COVID-19 infection in the last 30 days prior to screening.
Pregnancy-related exclusions, include:
Primary purpose
Allocation
Interventional model
Masking
4 participants in 2 patient groups, including a placebo group
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Central trial contact
Deven V Parmar; Farheen Shaikh
Data sourced from clinicaltrials.gov
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