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Inhibition of 11β-Hydroxysteroid dehydrogenase-1 with AZD4017 in patients with nonalcoholic steatohepatitis or nonalcoholic fatty liver disease: A randomized, double-blind, placebo-controlled, phase II study

Diabetes, Obesity and Metabolism Jan 28, 2022

In patients with nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH), with or without type 2 diabetes (T2D), it was investigated if short-term therapy with a selective 11β-Hydroxysteroid dehydrogenase-1 (11β-HSD1) inhibitor, AZD4017, would block hepatic cortisol generation and thereby reduce hepatic fat.

  • This randomized, double-blind, placebo-controlled, phase 2 study included 93 patients with NAFLD or NASH who were randomized (1:1) to AZD4017 or placebo for 12 weeks; 85 patients completed treatment.

  • In the AZD4017 and placebo groups, mean (standard deviation [SD]) alteration in liver fat fraction (LFF) was −0.667 (5.246) and 0.139 (4.323), respectively.

  • In both the groups, mean (SD) change in LFF was significantly improved for those with NASH and T2D (−1.087 [5.374] vs 1.675 [3.318]).

  • No significant between-group differences (AZD4017 vs placebo) were observed in changes in fibrosis, weight, levels of liver enzymes or lipids, or insulin sensitivity.

  • In this study, one of the primary outcomes was not met, conversion of <sup>13</sup> C cortisone to <sup>13</sup> C cortisol in the liver was blocked by AZD4017 in all patients who received the drug.

  • Treatment with AZD4017 led to liver steatosis improvement in patients with NASH and T2D, compared with placebo.

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