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

Inclusion criteria

• Symptoms of gastroparesis (eg, nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening
• Composite score ≥2and <5 on nausea, bloating, feeling excessively full after meals, and not able to finish a normal-sized meal items (on the GCSI-2W) at Screening
• Delayed gastric emptying by either GES (gastric emptying scintigraphy) or GEBT(gastric emptying breath test)
• Upper gastrointestinal obstruction ruled out by endoscopy or other imaging (eg, computed tomography) after the onset of gastroparesis symptoms
• Willing to abstain from prohibited medications, including but not limited to, anticholinergics, acetylcholinesterase antagonists, or promotility medications (eg, metoclopramide, domperidone, prucalopride, erythromycin) for: 24 hours prior to gastric emptying test during Screening, if applicable; 24 hours prior to start of the Baseline period; and during the Baseline Period
• GCSI-24H 7-day mean composite score ≥2.5 and <5 at Day 1

Exclusion criteria

• If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level >11%
• Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication, which has manipulated the natural anatomy of the stomach
• History of intrapyloric botulinum toxin injection within 3 months of Screening or currently has functioning implantable electric stimulator
• History of alcohol or drug abuse or dependence within the last year prior to Screening