A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Diabetic Gastroparesis
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:
Participants will go through the following schedule:
Screening period (1-2 visits)
Lead-in period (1 visit)
12-week treatment period (7 visits)
1 week follow-up (1 visit)
Researchers will compare the effects of the following treatments:
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:
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:
Willing to washout from ongoing treatment for gastroparesis.
Key Exclusion Criteria:
Englewood, New Jersey 07631, United States
Freehold, New Jersey 07728, United States
Jackson, New Jersey 08527, United States
Arlington, Texas 76012, United States