Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison

Table 4

Least-squares mean change from baseline to Week 24 (Visit 12) in the safety measures.

Measure; total score	Double-blind Treatment Phase					𝑃 value^a
	Pomaglumetad methionil (𝑁=511)		Aripiprazole (𝑁=161)		LS mean difference between pomaglumetad methionil and aripiprazole (SE)
	Baseline mean (SD)	Δ to Week 24 (Visit 12) LS mean (SE)	Baseline mean (SD)	Δ to Week 24 (Visit 12) LS mean (SE)
Weight (kg)	89.80 (22.04)	−2.8 (0.4)	90.18 (22.80)	0.4 (0.6)	−3.2 (0.7)	<0.001*
BMI (kg/m^2)	30.35 (7.32)	−1.0 (0.1)	30.72 (7.63)	0.2 (0.2)	−1.1 (0.2)	<0.001*
Waist circumference (cm)	100.9 (16.8)	−2.3 (0.3)	101.8 (18.0)	0.4 (0.6)	−2.7 (0.6)	<0.001*
EPS
BAS	0.1 (0.5)	0.00 (0.03)	0.1 (0.4)	−0.04 (0.04)	0.04 (0.04)	0.353
SAS	0.5 (1.7)	−0.17 (0.06)	0.4 (1.2)	−0.20 (0.08)	0.03 (0.09)	0.698
AIMS	0.3 (1.2)	−0.11 (0.05)	0.3 (1.1)	−0.10 (0.07)	−0.01 (0.07)	0.924

^∗𝑃<0.001.
^a𝑃 values are from type III tests of LS mean differences between treatments at each visit from MMRM.
Δ: change from baseline; LS mean: least-squares means; AIMS: Abnormal Involuntary Movement Scale; BAS: Barnes Akathisia Scale; cm: centimeter; EPS: extrapyramidal symptoms; kg: kilogram; kg/m²: kilogram per square meter; MMRM: mixed-effects model with repeated measures; 𝑁: number of patients; SAS: Simpson-Angus Scale; SD: standard deviations; SE: standard error.