Overview
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 (5 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 1
- Drug- CIN-102 Dose 2
- Drug- Placebo
Eligibility
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:
- 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 45 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:
- 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.
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);
- 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.