The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study

Summary

Study 0099 explores the efficacy and safety of multiple doses of velusetrag in the treatment of symptoms in subjects with diabetic or idiopathic gastroparesis. Three dose levels of velusetrag will be evaluated and compared to placebo for approximately 12 weeks of therapy. In addition, the study will be used to evaluate the psychometric properties of the Gastroparesis Rating Scale (GRS), a daily patient-reported outcome (PRO) measure.

Timeline

Start

2014-12

Primary completion

2017-06

Completion

2017-06

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

paper Hochberg-adjusted p = 0.0980 [not significant] reads as missed primary endpoint PMID 36624727 ↗

release “Top-line results from the study demonstrated statistically significant improvements in gastroparesis symptoms and gastric emptying in patients receiving 5 mg of velusetrag as compared to placebo.” reads as met primary endpoint theravance.com ↗

Publications

• Abell TL, Kuo B, Esfandyari T, Pfeifer ND, Grimaldi M, Renzulli C, Tacchi R, Zhou K, Barnes CN, Nguyen DD, Nguyen L, Talley NJ, McCallum R. A randomized, double-blind, placebo-controlled, phase 2b study of the efficacy and safety of velusetrag in subjects with diabetic or idiopathic gastroparesis. Neurogastroenterol Motil. 2023 Apr;35(4):e14523. doi: 10.1111/nmo.14523. Epub 2023 Jan 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Velusetrag	Small molecule	5 mg	—
Subject	Velusetrag	Small molecule	15 mg	—
Subject	Velusetrag	Small molecule	30 mg	—

Indications