NCT04303195

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

A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study, of the Safety and Efficacy of NG101 Administered Orally to Patients With Gastroparesis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Neurogastrx, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind, parallel-group , placebo-controlled, multicenter US-based study to evaluate the safety and efficacy of 3 dose levels of NG101 (Metopimazine mesylate) compared with placebo in participants with diabetic or idiopathic gastroparesis. The study will enroll approximately 140 participants. Following the Screening Period, there is a 2-week Pretreatment Period during which participants will complete an electronic daily diary. Participants eligible for the clinical study will be randomly assigned (in a 1:1:1:1 ratio) to receive either NG101 5 mg, 10 mg, or 20 mg, or matching placebo during a 12-week Treatment Period. All participants will be asked to take one capsule 30 minutes before a meal 3 times a day and 30 minutes before bedtime for a total of 4 capsules daily (QID). The total duration of the study for each participant will be approximately 20 weeks.

Conditions

• Diabetic Gastroparesis
• Idiopathic Gastroparesis

Interventions

Type	Name	Description
DRUG	NG101	Capsules
DRUG	Placebo	Capsules

Timeline

• Start date: 2020-08-01
• Primary completion: 2023-02-25
• Completion: 2023-02-25
• First posted: 2020-03-10
• Last updated: 2025-08-28
• Results posted: 2025-08-28

Locations

83 sites across 1 country: United States

Regulatory

• FDA-regulated drug study