Table 3.
Study efficacy endpoints.
| Primary efficacy endpoint | Timing | Study population |
|---|---|---|
| Proportion of participants who achieve ≥10% reduction from baseline in body weight | ~52 weeks of treatmenta | FAS among those who are ≥12 years of age at baseline |
| Key secondary endpoints | ||
| Mean percent change from baseline in body weight | ~52 weeks of treatmenta | FAS among those who are ≥12 years of age at baseline |
| Mean percent change in weekly average of daily hunger score | ~52 weeks of treatmenta | FAS among those who are ≥12 years of age at baseline |
| Proportion of participants who achieve ≥25% reduction in weekly average of daily hunger score | ~52 weeks of treatmenta | FAS among those who are ≥12 years of age at baseline |
| Other secondary endpoints | ||
| Mean percent change from baseline in body weight compared with placebo | Week 14 | PCS among those who are ≥12 years of age at baseline |
| Mean percent change in weekly average of daily hunger score compared with placebo | Week 14 | PCS among those who are ≥12 years of age at baseline |
FAS, full analysis set; PCS, 14-week placebo-controlled analysis set.
a
Treatment with setmelanotide. For participants randomized to the setmelanotide group, baseline is defined as the last available measurement prior to the randomization; for participants randomized to the placebo group, baseline is defined as the last available measurement prior to the first dose of open-label setmelanotide treatment.