We tested the hypothesis that long-term treatment with
pomaglumetad methionil would demonstrate significantly less
weight gain than
aripiprazole in patients with
schizophrenia. In this 24-week, multicenter, randomized, double-blind, Phase 3 study, 678
schizophrenia patients were randomized to either
pomaglumetad methionil (n = 516) or
aripiprazole (n = 162). Treatment groups were also compared on efficacy and various safety measures, including serious adverse events (SAEs), discontinuation due to adverse events (AEs), treatment-emergent adverse events (TEAEs), extrapyramidal symptoms (EPS), and suicide-related thoughts and behaviors. The
pomaglumetad methionil group showed significantly greater
weight loss at Week 24 (Visit 12) compared with the
aripiprazole group (-2.8 ± 0.4 versus 0.4 ± 0.6; P < 0.001). However, change in Positive and Negative Syndrome Scale (PANSS) total scores for
aripiprazole was significantly greater than for
pomaglumetad methionil (-15.58 ± 1.58 versus -12.03 ± 0.99; P = 0.045). The incidences of SAEs (8.2% versus 3.1%; P = 0.032) and discontinuation due to AEs (16.2% versus 8.7%; P = 0.020) were significantly higher for
pomaglumetad methionil compared with
aripiprazole. No statistically significant differences in the incidence of TEAEs, EPS, or suicidal ideation or behavior were noted between treatment groups. In conclusion, long-term treatment with
pomaglumetad methionil resulted in significantly less
weight gain than
aripiprazole. This trial is registered with ClinicalTrials.gov NCT01328093.