Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis

Phase 2 Completed 201 enrolled Tranzyme, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to test the safety and effectiveness of two dosage levels (10mg and 20mg) of TZP-102 compared to placebo (capsule that looks like the study drug but contains no active drug), administered once-daily for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.

Timeline

Start: 2011-09
Primary completion: 2012-11
Completion: 2012-11

Outcome

Missed primary endpoint

paper Primary endpoint (GSDD): significant improvement in all arms, although not for TZP-102 vs placebo: 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
Subject	TZP-102	Protein / enzyme biologic	20 mg	Oral