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Status and phase
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About
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 (5 visits)
1 week follow-up (1 visit)
Researchers will compare the effects of the following treatments:
Enrollment
Sex
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Volunteers
Inclusion and exclusion 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:
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:
Willing to washout from ongoing treatment for gastroparesis.
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
400 participants in 3 patient groups, including a placebo group
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Central trial contact
Rachael Farley
Data sourced from clinicaltrials.gov
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