A Multicenter, Phase II Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis

Inclusion Criteria:

- Symptoms of gastroparesis (e.g., nausea, early satiety, fullness, bloating, upper
abdominal pain, retching or vomiting) for at least 3 months prior to Screening

- Body Mass Index (BMI) between 18 and 35 kg/m2, inclusive

- Gastroparesis Cardinal Symptom Index (GCSI-2W) composite score ≥2 and ≤4 at Screening

- Delayed gastric emptying, defined as a gastric emptying half-time (GE t1/2) > 160
minutes as determined by [13C]-octanoate breath test, at Screening

- Upper gastrointestinal (UGI) obstruction ruled out by endoscopy or other imaging
reasonably proximal to the diagnosis of gastroparesis

Exclusion Criteria:

- Acute severe gastroenteritis within 2 weeks prior to Screening

- History of gastric outlet obstruction

- Prior history of gastric surgery, including but not limited to gastrectomy, gastric
bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication

- Recurrent vomiting, defined as vomiting more than 2 days per week

- Hospitalization for treatment of gastroparesis or complications of diabetes within 4
weeks prior to Screening

- Presence of thyroid dysfunction not controlled by treatment. Subjects with abnormal
thyroid stimulating hormone (TSH), hypothyroidism, or hyperthyroidism at Screening

- If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level >10% or a
glucose > 250 mg/dL at Screening