Multicentre, randomised, double-blind, placebo-controlled, 48-week, Phase III trial to evaluate the efficacy and safety of survodutide administered subcutaneously in participants with overweight or obesity and presumed or confirmed nonalcoholic steatohepatitis (NASH)

Obesity

Relative reduction in liver fat content of at least 30% from baseline to Week 48 (yes/no) assessed by MRI-PDFF [%], Relative change (%) in body weight [kg] from baseline to Week 48

Absolute change from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%], Reduction from baseline to Week 48 in cT1 [ms] levels of ≥80 ms (yes/no), Absolute and relative change from baseline to Week 48 in ALT [U/L] levels, Absolute and relative change from baseline to Week 48 in HOMA-IR (FPI [mlU/L]·FPG [mmol/L]/22.5), Absolute and relative change from baseline to Week 48 in liver stiffness [kPa] assessed by MRE, Absolute and relative change in liver volume [mL] from baseline to Week 48 measured using MRI, Absolute and relative change from baseline to Week 48 in waist circumference [cm], Relative change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%]

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Germany, Netherlands, Spain