A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis

Inclusion Criteria

• •Is a male or female ≥18 years of age;
• •Has a diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association criteria;
• •Has a current diagnosis of diabetic gastroparesis defined by the following:
• •1. Persistent gastrointestinal symptoms that in the opinion of the Investigator are consistent with gastroparesis within 6 months prior to Screening; AND
• •2. Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT), scintigraphy, or manometry.
• •Body mass index (BMI) between 18 and 49 kg/m2, inclusive;
• •Glycosylated hemoglobin (HbA1c) level \<10% at Screening;
• •If receiving treatment with GLP-1RA, may be considered for the study if all of the following criteria are satisfied:
• •1. The GLP-1 RA has been prescribed for the management of diabetes and not specifically for weight loss/weight management;
• •2. Has been on a stable dose of GLP-1RA for a minimum of 3 months before Screening and is anticipated to sustain the same dose during GEBT and throughout the study;
• •3. Is tolerating the GLP-1RA well based on Investigator's judgment;
• •4. None of the study-qualifying signs/symptoms of gastroparesis are solely attributable to the use of GLP-1RA; and
• •5. The symptoms of gastroparesis preceded the initiation of GLP-1RA therapy.
• •Willing to washout from ongoing treatment for gastroparesis.