Incidence, frequency, and duration of vomiting assessed using the MASCC Antiemesis Tool - Modified Index of Nausea and Vomiting (M-INVR)
Time frame · Baseline to Week 76
Vomiting is assessed weekly using the MASCC Antiemesis Tool - Modified Index of Nausea and Vomiting (M-INVR), a validated patient-reported outcome measure.
The vomiting subscale score is calculated as the sum of relevant vomiting items, with scores ranging from 0 to 16, where higher scores indicate greater incidence, frequency, and duration of vomiting (worse outcome).
Change in body weight
Time frame · Baseline to Week 76
Absolute and percentage change in body weight from baseline.
Proportion of participants remaining on active study medication
Time frame · Week 76
Number of participants continuing to receive active study medication at the end of the trial.
Change in glycated hemoglobin (HbA1c)
Time frame · Baseline to Week 76
Change in HbA1c from baseline.
Change in lean body mass assessed by dual-energy X-ray absorptiometry (DEXA)
Time frame · Baseline to Week 76
Change in total lean body mass measured by dual-energy X-ray absorptiometry (DEXA).
Change in visceral adiposity assessed by dual-energy X-ray absorptiometry (DEXA)
Time frame · Baseline to Week 76
Change in visceral adipose tissue measured by dual-energy X-ray absorptiometry (DEXA).
Change in fat body mass assessed by dual-energy X-ray absorptiometry (DEXA)
Time frame · Baseline to Week 76
Change in total fat body mass measured by dual-energy X-ray absorptiometry (DEXA).
Change in Alanine Aminotransferase (ALT)
Time frame · Baseline to Week 76
Change from baseline in serum alanine aminotransferase (ALT) levels in U/L, measured using standard laboratory methods.
Change in Aspartate Aminotransferase (AST)
Time frame · Baseline to Week 76
Change from baseline in serum aspartate aminotransferase (AST) levels in U/L, measured using standard laboratory methods.
Change in Gamma-Glutamyl Transferase (GGT)
Time frame · Baseline to Week 76
Change from baseline in serum gamma-glutamyl transferase (GGT) levels in U/L, measured using standard laboratory methods.