Study end point
NASH, fibrosis, steatohepatitis
ADVERSE EVENTS, SECONDARY, FIBROSIS, STEATOHEPATITIS
The primary objective/end point of TANDEM was to evaluate the safety and tolerability of TXR plus CVC in patients with NASH and fibrosis (stages F2/F3) by monitoring adverse events (AEs), vital signs, and laboratory values during 48 weeks of treatment as compared with TXR and CVC monotherapy. This primary objective was chosen as this was the first study to investigate combined FXR agonism with CCR2/5 antagonism in patients with NASH. The secondary end points of this study were to evaluate the proportion of patients who had at least a 1-point improvement in fibrosis stage (NASH CRN) without worsening of steatohepatitis and the proportion of patients with resolution of steatohepatitis without worsening of fibrosis, after 48 weeks of treatment. Exploratory end points included were reported