Different Doses of Naronapride Vs. Placebo in Gastroparesis

Inclusion Criteria:

• Men and women between ≥18 and ≤75 years of age,

• Body Mass Index (BMI) ≥16 and <35 kg/m2 ,

• History of idiopathic or diabetic gastroparesis cardinal symptoms (e.g., nausea,vomiting, early satiety, postprandial fullness, bloating or upper abdominal pain)for ≥3 months,

• Evidence of delayed gastric emptying by 13C-spirulina gastric emptying breath test (GEBT) for solids with gastric emptying T1/2 ≥ 85.33 minutes (≥ 90th percentile ofnormative data) during the screening phase,

• Average weekly total symptom score of the ANMS GCSI-DD ≥2.0 based on the dailysymptom scores recorded for at least 5 of 7 consecutive days in the week prior toBaseline,

• Participants with a type I or type II diabetes mellitus diagnosis must have acontrolled diabetes mellitus defined as HbA1c ≤11% under stable antidiabeticmedication,

• Exclusion of any mechanical and/or anatomical obstructions, stenosis, structuraldiseases, or gastric ulcers by upper gastrointestinal endoscopy during screeningphase (previous endoscopic results within 12 months are acceptable, if no relevantchanges in patient's disease status occurred since that time),

• No evidence of intestinal stenosis as determined by an imaging technique (i.e.,either abdominal sonography, Magnetic resonance imaging [MRI] or imaging by computedtomography [CT] during screening phase (previous MRI/CT imaging or sonographyresults within 12 months are acceptable, if no relevant changes occurred inpatient's disease status since that time),

Exclusion Criteria:

• History of major gastrointestinal surgery such as gastric bypass, anti-refluxsurgery, gastric per oral endoscopic myotomy (G-POEM), gastrointestinal malignancy,colectomy,

• Intrapyloric botulinum toxin injection within 12 months,

• Gastric stimulator implant,

• Known secondary causes of gastroparesis including but not limited to Parkinson'sDisease, cancer, or connective tissue diseases,