A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis
- Conditions
- Diabetic Gastroparesis
- Interventions
- Drug: CIN-102 Dose 15mg or 10mgDrug: Placebo
- Registration Number
- NCT05832151
- Lead Sponsor
- CinDome Pharma, Inc.
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 360
-
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 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:
- The GLP-1 RA has been prescribed for the management of diabetes and not specifically for weight loss/weight management;
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CIN-102: Dose 15mg or 10mg CIN-102 Dose 15mg or 10mg CIN-102, Dose 15 mg or 10 mg, twice daily for 12 weeks Placebo Placebo Placebo for CIN-102, twice daily for 12 weeks
- Primary Outcome Measures
Name Time Method Effect of CIN-102 to significantly decrease gastroparesis-related symptoms as compared to baseline based on the composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores Over the last 2 weeks of the 12-week Treatment Period as compared to baseline The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea Subscale scores and the Vomiting subscale scores will be averaged into a single value that ranges 0-4 (0 for no symptom and 4 for very severe)
- Secondary Outcome Measures
Name Time Method Incidence of treatment emergent Serious Adverse Events (SAEs) Over the 12-week Treatment Period Incidence of treatment-emergent marked laboratory abnormalities. Over the 12-week Treatment Period Percentage of responders who demonstrate an average ≥0.5 reduction from baseline on the ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores Over the last 2 weeks of the 12-week Treatment Period Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline Over the last 2 weeks of the 12-week Treatment Period as compared to baseline Based on the average ANMS GCSI-DD Total and Sub-Scale Scores
The change in the composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores among subjects receiving glucagon-like peptide-1 receptor agonist (GLP-1RA) Over the 12-week Treatment Period as compared to baseline The percentage of responders among subjects receiving GLP-1RA who demonstrate an average ≥0.5 reduction from baseline on the ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores Over the last 2 weeks of the 12-week Treatment Period Percentage of subjects achieving a ≥30% reduction from baseline on a composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores Over the last 2 weeks of the 12-week Treatment Period Incidence of treatment-emergent adverse events (TEAEs) Over the 12-week Treatment Period Incidence of TEAEs leading to premature discontinuation of study drug Over the 12-week Treatment Period Change in the PGIC with each dose of CIN-102 From baseline to Week 12 The percentage of symptom-free days in the ANMS GCSI-DD Total Score, a composite of the Nausea Sub-Scale and Vomiting Scores, and Sub-Scale Scores Over the last 2 weeks of the 12-week Treatment Period Symptomatic days defined as \>mild (ANMS GCSI-DD scores \>2)
The relationship between ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores and Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) over the 12-week Treatment Period; Over the 12-week Treatment Period Change in the PGIS with each dose of CIN-102 From baseline to Week 12 Incidence of clinically significant changes, in the Investigator's opinion, in laboratory parameters, physical examination findings, 12-lead ECG parameters, weight measurement. Over the 12-week Treatment Period Percentage of subjects with a history of a lack of response or who could not tolerate metoclopramide therapy or other prokinetics, who demonstrate a >30% reduction from baseline on a composite score Over the last 2 weeks of the 12-week Treatment Period as compared to baseline Composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores
The change in the ANMS GSCI-DD Total Score and a composite of gastroparesis-related symptoms among subjects receiving GLP-1RA; over the last 2 weeks of the 12-week Treatment Period, as compared to baseline All endpoints that are evaluated over the last 2 weeks of the 12-week Treatment period will also be evaluated over the last 6 weeks of the 12-week Treatment period. Over the last 6 weeks of the 12-week Treatment Period The percentage of subjects receiving GLP-1RA who achieve a ≥30% reduction from baseline on the ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores Over the last 2 weeks of the 12-week Treatment Period
Trial Locations
- Locations (99)
Digestive Health Specialists of the Southeast
🇺🇸Dothan, Alabama, United States
G & L Research, LLC
🇺🇸Foley, Alabama, United States
Clinical Research Associates, LLC
🇺🇸Huntsville, Alabama, United States
Phoenix Medical Research Institute, LLC
🇺🇸Peoria, Arizona, United States
Onyx Clinical Research
🇺🇸Phoenix, Arizona, United States
Del Sol Research Management, LLC
🇺🇸Tucson, Arizona, United States
Preferred Research Partners, Inc.
🇺🇸Little Rock, Arkansas, United States
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
Arkansas Gastroenterology - North Little Rock
🇺🇸North Little Rock, Arkansas, United States
Alliance Research Institute - Bell Gardens
🇺🇸Bell Gardens, California, United States
Scroll for more (89 remaining)Digestive Health Specialists of the Southeast🇺🇸Dothan, Alabama, United States