Sequence generation {16a}
NASH, T2DM
DISEASE
In the 1366.0021 trial, patients will be randomised 1:1:1 via a validated system (Interactive Response Technology [IRT]) to receive placebo, moderate or high dose BI 685509, stratified by the use of NSBBs or carvedilol. In the 1366.0029 trial, patients will be assigned to their treatment group using IRT based on underlying disease aetiology (HBV, HCV or NASH), and all patients will receive high dose BI 685509. In addition, a subgroup of patients with NASH and T2DM will be randomised 1:1 via IRT to receive BI 685509 alone or in combination with empagliflozin. The randomisation list for each group will be generated using IRT that uses a pseudorandom number generator so that the assignment of treatment will be reproducible and non-predictable.