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

Launched by CINDOME PHARMA, INC. · Apr 14, 2023

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ClinConnect Summary

This clinical trial is studying a medication called CIN-102 (deudomperidone) to see if it can help adults with diabetic gastroparesis, a condition where the stomach takes too long to empty its contents. The main focus of the trial is to find out if this medication can reduce the symptoms of gastroparesis compared to a placebo, which is a dummy treatment that contains no active ingredients. Researchers will also look at how safe CIN-102 is for patients.

To participate in this study, individuals must be at least 18 years old, have a diagnosis of Type 1 or Type 2 diabetes, and currently experience symptoms of diabetic gastroparesis. Participants will go through a screening process and then take the study drug or placebo for 12 weeks, documenting their symptoms in daily diaries. There will be several visits throughout the trial, including a follow-up week after treatment ends. If you or a loved one are interested, it’s essential to check eligibility criteria, as certain health conditions or treatments may exclude someone from participating.

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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.