Evaluation of Efficacy Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b Randomized Double-blind Placebo-controlled Multi-center Study in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)

Brief description of study

The purpose of the study is to examine the effectiveness of aldafermin for the treatment of cirrhosis caused by nonalcoholic steatohepatitis (NASH). The study will study how safe and effective aldafermin is as compared to a placebo (looks like aldafermin, but doesn’t contain the active ingredient). In addition, the study will also study how safe and effective rosuvastatin is for the treatment of high cholesterol when taken with aldafermin. Aldafermin is considered an investigational medicinal product. Rosuvastatin is not a medication to treat cirrhosis but may be used in this study to treat high cholesterol if needed. The use of aldafermin in combination with rosuvastatin is investigational and has not been approved by (FDA).


Clinical Study Identifier: s19-01378
ClinicalTrials.gov Identifier: NCT04210245
Principal Investigator: Viviana Figueroa Diaz.


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