Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of PALSONIFY was evaluated in adults with acromegaly in two randomized, double-blind, placebo-controlled Phase 3 studies. Study 1 was a 24-week, randomized, placebo-controlled study in 111 adults who were naive or previously treated on a somatostatin analog and biochemically uncontrolled at randomization. Participants in Study 1 had a mean age of 47 years (range: 18 to 80 years) and were randomized to PALSONIFY (n=54) or placebo (n=57)

Study 1 (NCT05192382) enrolled 111 adult participants with biochemically uncontrolled acromegaly. Participants were either treatment naïve (n=46/111) or had no treatment within the previous 4 months prior to screening (n=36/111) (‘Not Medically Treated’ group) or were previously treated on a somatostatin receptor analog and then washed out of treatment during screening (n=29/111) (‘Washout’ group). The mean age at enrollment was 47 years (range: 18 to 80 years); 53% were female; and 52% were White, 31% Asian, 3% Black or African American, 9% Other, and 5% Unknown race. The mean duration since diagnosis of acromegaly was 87 months. Prior to study participation, 95% of participants had received pituitary surgery (mean duration 78 months prior to study participation). Of the 111 participants, 86 (78%) had macroadenomas (>10 mm), 9 (8%) had microadenomas (≤10 mm), and tumor size was unknown in 16 (14%) participants. In the ‘Not Medically Treated’ group, IGF-1 levels were required to be ≥1.3×ULN at screening. In the ‘Washout’ group, IGF-1 levels were required to be ≤1.0×ULN at screening and ≥1.1×ULN with at least a 30% rise in IGF-1 after washout. Participants were randomized to receive either PALSONIFY (n=54) or placebo (n=57) for the 24-week treatment period.

Study 2 (NCT04837040) enrolled 58 participants who were previously biochemically controlled (defined as IGF-1 levels ≤1.0×ULN during screening and at randomization) on injectable depot octreotide or lanreotide somatostatin analog formulations. The mean age at enrollment was 55 years (range: 29 to 84 years); 55% were female; and 72% were White, 3% Asian, 5% Black or African American, 12% Other, and 7% Unknown race. The mean duration since diagnosis of acromegaly was 155 months. Prior to study participation, 86% of participants had received pituitary surgery (mean duration 138 months prior to study participation). Of the 58 participants, 33 (57%) had macroadenomas (>10 mm), 11 (19%) had microadenomas (≤10 mm), and tumor size was unknown in 14 (24%) participants. Participants were randomized to receive either PALSONIFY (n=30) or placebo (n=28) for the 36-week treatment period.