A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Diabetic Gastroparesis
The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help reduce the symptoms associated with diabetic gastroparesis in adult patients. The main questions it aims to answer are: * To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with diabetic gastroparesis compared to a placebo * To evaluate the safety and tolerability of CIN-102 when given to patients with diabetic gastroparesis compared to a placebo Participants will go through the following schedule: * Screening period (1-2 visits) * Lead-in period (1 visit) * Will complete a Gastric Emptying Breath Test (GEBT) * Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation * 12-week treatment period (7 visits) * Study drug taken twice daily by mouth * Will complete daily diaries and other PROs as described in protocol * 1 week follow-up (1 visit) Researchers will compare the effects of the following treatments: * Drug- CIN-102 Dose 15 mg or 10 mg * Drug- Placebo
• 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:
‣ Persistent gastrointestinal symptoms that in the opinion of the Investigator are consistent with gastroparesis within 6 months prior to Screening; AND
⁃ 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:
‣ The GLP-1 RA has been prescribed for the management of diabetes and not specifically for weight loss/weight management;
⁃ 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;
⁃ Is tolerating the GLP-1RA well based on Investigator's judgment;
⁃ None of the study-qualifying signs/symptoms of gastroparesis are solely attributable to the use of GLP-1RA; and
⁃ The symptoms of gastroparesis preceded the initiation of GLP-1RA therapy.
• Willing to washout from ongoing treatment for gastroparesis.