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HSS Journal (2025) 8
211 A randomized controlled trial involving 100 CKD patients reported that consuming 3,666 mg EPA and DHA daily was not more effective than corn oil at reducing urine albumin levels, but the formulation did improve blood vessel function and lower triglyceride levels more than corn oil
This data provided enough confidence for the company to continue to evaluate the efficacy and safety of this drug in a Phase 3 AURORA trial (Figure 1) (ClinicalTrials.gov NCT03028740), enrolling approximately 2000 NASH patients with fibrosis (CRN stage 2 or 3)
Its proposed mechanism of action includes stimulation of glucose-dependent insulin secretion, suppression of glucagon (via GLP-1), enhanced lipid metabolism (via GIP), and increased energy expenditure (via glucagon receptor activation)
PubMed Sinha R, et al
