a study to evaluate the efficacy and safety of cin-102 (deudomperidone) in adults with diabetic gastroparesis

Conditions: Diabetic Gastroparesis

Summary: 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


Eligibility criteria:
key 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. key exclusion criteria: * has known cause of gastroparesis other than diabetes (eg, idiopathic gastroparesis and/or gastroparesis attributed to surgery, viral illness, cancer, scleroderma, or other neurologic disorder); * has been hospitalized within 3 months prior to visit 1 for diabetic gastroparesis and/or diabetic ketoacidosis and/or malnutrition; * history or evidence of clinically significant arrhythmia; * history of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy, fundoplication, gastrectomy, vagotomy, or bariatric surgery; * currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression; * pyloric injection of botulinum toxin within 6 months of screening; * positive test for drugs of abuse; * has a known allergy to eggs or spirulina; * females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

Keywords: gastroparesis diabetic gastroparesis gastrointestinal disease delayed gastric emptying digestive system diseases nausea vomiting stomach dopamine receptor antagonist