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


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.