Setmelanotide for the Treatment of Acquired Hypothalamic Obesity

To the Editor: Miller et al. (July 9 issue) 1 found a placebo-adjusted difference of −19.8 percentage points in the mean body-mass index (BMI) with setmelanotide in the 120-participant cohort of the TRANSCEND trial. Two aspects of the article diverge from the regulatory record of the same trial. Food and Drug Administration (FDA) approval of setmelanotide for the treatment of acquired hypothalamic obesity on March 19, 2026, rested on data from all 142 randomly assigned participants, among whom the placebo-adjusted difference in BMI was −18.4 percentage points with setmelanotide; two deaths, rather than one, occurred with setmelanotide. 2,3 The resulting label carries . . .