Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)

Phase 2 Completed 90 enrolled Ironwood Pharmaceuticals, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objectives of this study are to evaluate the safety of IW-9179 in patients with diabetic gastroparesis (DGP) and the effect of treatment on the cardinal symptoms of DGP.

Timeline

Start: 2014-10
Primary completion: 2015-12
Completion: 2015-12

Outcome

Missed primary endpoint

release “gastroparesis. Top-line data indicate IW-9179 did not meaningfully improve these symptoms relative to placebo.” ironwoodpharma.com ↗

Publications

Ervin CM, Reasner DS, Hanlon JT, Fehnel SE. Exploring the Diabetic Gastroparesis Patient Experience: Patient Exit Interviews. Adv Ther. 2017 Dec;34(12):2680-2692. doi: 10.1007/s12325-017-0632-6. Epub 2017 Oct 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RECANACLOTIDE	Protein / enzyme biologic	—	Oral