A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis
Purpose
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
Condition
- Diabetic Gastroparesis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CIN-102: Dose 15mg or 10mg |
CIN-102, Dose 15 mg or 10 mg, twice daily for 12 weeks |
|
|
Placebo Comparator Placebo |
Placebo for CIN-102, twice daily for 12 weeks |
|
Recruiting Locations
Kansas City, Kansas 66160
More Details
- Status
- Recruiting
- Sponsor
- CinDome Pharma, Inc.