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No effective medical therapy has been approved for the treatment of nonalcoholic steatohepatitis (NASH), a leading indication for liver transplantation.
In an industry-funded, phase II study, researchers tested the efficacy of NGM282 (a nontumorigenic variant of fibroblast growth factor 19 protein), randomizing 82 patients with biopsy-proven NASH to receive 3 mg or 6 mg of subcutaneous NGM282 or placebo daily for 12 weeks. Eligible patients had a nonalcoholic fatty liver disease activity score ≥4, fibrosis stage 1, 2, or 3, and liver fat content ≥8%. Randomization stratified patients by diabetic status. Response was defined as a reduction in liver fat content of ≥5% from baseline to week 12, as measured by MRI-proton density fat fraction.
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