A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis

Phase 2 Completed 161 enrolled Neurogastrx, Inc.

RandomizedParallel-groupQuadruple-blindOther

Summary

The purpose of this study is to assess the safety and efficacy of various dose levels of NG101 compared with placebo in adult participants with gastroparesis during 12 weeks of treatment.

Timeline

Start: 2020-08-01
Primary completion: 2023-02-25
Completion: 2023-02-25

Publications

Loesch J, Hamza E, Pasricha PJ, Nee J, Cline M, MacDougall J, Simons M, Brown JT, Garg S, Hoscheit M, Gabbard S, De Colle C, Lembo A. A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Metopimazine Mesylate (NG101) in Participants With Gastroparesis. Am J Gastroenterol. 2026 Feb 1;121(2):534-544. doi: 10.14309/ajg.0000000000003534. Epub 2025 May 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	metopimazine	Gene therapy (AAV / viral vector)	5 mg	Oral
Subject	metopimazine	Gene therapy (AAV / viral vector)	10 mg	Oral
Subject	metopimazine	Gene therapy (AAV / viral vector)	20 mg	Oral

A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis

Summary

Timeline

Publications

Drugs

Indications