Diabetic Gastroparesis Efficacy/Safety Study of TZP-102

Phase 2 Terminated 120 enrolled Tranzyme, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given prior to meals three times a day compared to placebo (capsule that looks like active study drug but contains no active drug), administered for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.

Timeline

Start: 2012-08
Primary completion: 2013-01
Completion: 2013-02

Outcome

Missed primary endpoint

Stopped: “Insufficient efficacy in planned interim futility analysis”

paper Efficacy of TZP-102 was not demonstrated compared with placebo in diabetic gastroparesis PMID 23848826 ↗

Publications

McCallum RW, Lembo A, Esfandyari T, Bhandari BR, Ejskjaer N, Cosentino C, Helton N, Mondou E, Quinn J, Rousseau F; TZP-102 Phase 2b Study Group. Phase 2b, randomized, double-blind 12-week studies of TZP-102, a ghrelin receptor agonist for diabetic gastroparesis. Neurogastroenterol Motil. 2013 Nov;25(11):e705-17. doi: 10.1111/nmo.12184. Epub 2013 Jul 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TZP-102	Protein / enzyme biologic	10 mg	Oral