A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients

Phase 3 Terminated 678 enrolled Denovo Biopharma LLC

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether weight gain will be significantly less in LY2140023 than aripiprazole in patients with schizophrenia.

Timeline

Start: 2011-04
Primary completion: 2012-10
Completion: 2012-10

Outcome

Met primary endpoint

Stopped: “The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.”

registry LEAST_SQUARES_MEAN LY2140023-DB: -2.8 (Standard Error 0.4) kilograms (kg) NCT01328093 ↗

registry analysis (unspecified test); LY2140023-DB vs Aripiprazole-DB; p <0.001; LS Mean Differences -3.2 NCT01328093 ↗

Publications

Adams DH, Zhang L, Millen BA, Kinon BJ, Gomez JC. Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison. Schizophr Res Treatment. 2014;2014:758212. doi: 10.1155/2014/758212. Epub 2014 Mar 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Aripiprazole	Other / unclassified	15 mg	Oral
Subject	LY2140023	Unknown	40 mg	Oral