Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT05832151
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2023-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 382}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2023-04-14', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': 'Over the last 2 weeks of the 12-week Treatment Period as compared to baseline', 'description': '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)'}], 'secondaryOutcomes': [{'measure': "Incidence of clinically significant changes, in the Investigator's opinion, in laboratory parameters, physical examination findings, 12-lead ECG parameters, weight measurement.", 'timeFrame': 'Over the 12-week Treatment Period'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Over the 12-week Treatment Period'}, {'measure': 'Incidence of treatment emergent Serious Adverse Events (SAEs)', 'timeFrame': 'Over the 12-week Treatment Period'}, {'measure': 'Incidence of TEAEs leading to premature discontinuation of study drug', 'timeFrame': 'Over the 12-week Treatment Period'}, {'measure': 'Incidence of treatment-emergent marked laboratory abnormalities.', 'timeFrame': 'Over the 12-week Treatment Period'}, {'measure': 'Percentage of responders who demonstrate an average ≥0.5 reduction from baseline on the ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores', 'timeFrame': 'Over the last 2 weeks of the 12-week Treatment Period'}, {'measure': 'Percentage of subjects achieving a ≥30% reduction from baseline on a composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores', 'timeFrame': 'Over the last 2 weeks of the 12-week Treatment Period'}, {'measure': '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', 'timeFrame': 'Over the last 2 weeks of the 12-week Treatment Period', 'description': 'Symptomatic days defined as \\>mild (ANMS GCSI-DD scores \\>2)'}, {'measure': '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;', 'timeFrame': 'Over the 12-week Treatment Period'}, {'measure': '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', 'timeFrame': 'Over the last 2 weeks of the 12-week Treatment Period as compared to baseline', 'description': 'Composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores'}, {'measure': 'Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline', 'timeFrame': 'Over the last 2 weeks of the 12-week Treatment Period as compared to baseline', 'description': 'Based on the average ANMS GCSI-DD Total and Sub-Scale Scores'}, {'measure': '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)', 'timeFrame': 'Over the 12-week Treatment Period as compared to baseline'}, {'measure': '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', 'timeFrame': 'Over the last 2 weeks of the 12-week Treatment Period'}, {'measure': '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', 'timeFrame': 'Over the last 2 weeks of the 12-week Treatment Period'}, {'measure': 'The change in the ANMS GSCI-DD Total Score and a composite of gastroparesis-related symptoms among subjects receiving GLP-1RA;', 'timeFrame': 'over the last 2 weeks of the 12-week Treatment Period, as compared to baseline'}, {'measure': '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.', 'timeFrame': 'Over the last 6 weeks of the 12-week Treatment Period'}, {'measure': 'Change in the PGIS with each dose of CIN-102', 'timeFrame': 'From baseline to Week 12'}, {'measure': 'Change in the PGIC with each dose of CIN-102', 'timeFrame': 'From baseline to Week 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastroparesis', 'Diabetic gastroparesis', 'Gastrointestinal disease', 'Delayed gastric emptying', 'Digestive system diseases', 'Nausea', 'Vomiting', 'Stomach', 'Dopamine receptor antagonist'], 'conditions': ['Diabetic Gastroparesis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gastroparesistrial.com/', 'label': 'Study website'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n* To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with diabetic gastroparesis compared to a placebo\n* To evaluate the safety and tolerability of CIN-102 when given to patients with diabetic gastroparesis compared to a placebo\n\nParticipants will go through the following schedule:\n\n* Screening period (1-2 visits)\n* Lead-in period (1 visit)\n\n * Will complete a Gastric Emptying Breath Test (GEBT)\n * Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation\n* 12-week treatment period (7 visits)\n\n * Study drug taken twice daily by mouth\n * Will complete daily diaries and other PROs as described in protocol\n* 1 week follow-up (1 visit)\n\nResearchers will compare the effects of the following treatments:\n\n* Drug- CIN-102 Dose 15 mg or 10 mg\n* Drug- Placebo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Is a male or female ≥18 years of age;\n* Has a diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association criteria;\n* Has a current diagnosis of diabetic gastroparesis defined by the following:\n\n 1. Persistent gastrointestinal symptoms that in the opinion of the Investigator are consistent with gastroparesis within 6 months prior to Screening; AND\n 2. Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT), scintigraphy, or manometry.\n* Body mass index (BMI) between 18 and 49 kg/m2, inclusive;\n* Glycosylated hemoglobin (HbA1c) level \\<10% at Screening;\n* If receiving treatment with GLP-1RA, may be considered for the study if all of the following criteria are satisfied:\n\n 1. The GLP-1 RA has been prescribed for the management of diabetes and not specifically for weight loss/weight management;\n 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;\n 3. Is tolerating the GLP-1RA well based on Investigator's judgment;\n 4. None of the study-qualifying signs/symptoms of gastroparesis are solely attributable to the use of GLP-1RA; and\n 5. The symptoms of gastroparesis preceded the initiation of GLP-1RA therapy.\n* Willing to washout from ongoing treatment for gastroparesis.\n\nKey Exclusion Criteria:\n\n* 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);\n* Has been hospitalized within 3 months prior to Visit 1 for diabetic gastroparesis and/or diabetic ketoacidosis and/or malnutrition;\n* History or evidence of clinically significant arrhythmia;\n* History of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy, fundoplication, gastrectomy, vagotomy, or bariatric surgery;\n* Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression;\n* Pyloric injection of botulinum toxin within 6 months of Screening;\n* Positive test for drugs of abuse;\n* Has a known allergy to eggs or spirulina;\n* Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study."}, 'identificationModule': {'nctId': 'NCT05832151', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis', 'organization': {'class': 'INDUSTRY', 'fullName': 'CinDome Pharma, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Diabetic Gastroparesis', 'orgStudyIdInfo': {'id': 'CIN-102-123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CIN-102: Dose 15mg or 10mg', 'description': 'CIN-102, Dose 15 mg or 10 mg, twice daily for 12 weeks', 'interventionNames': ['Drug: CIN-102 Dose 15mg or 10mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for CIN-102, twice daily for 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CIN-102 Dose 15mg or 10mg', 'type': 'DRUG', 'description': '2 capsules twice daily for 12 weeks', 'armGroupLabels': ['CIN-102: Dose 15mg or 10mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '2 capsules twice daily for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Digestive Health Specialists of the Southeast', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '36535', 'city': 'Foley', 'state': 'Alabama', 'country': 'United States', 'facility': 'G & L Research, LLC', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Associates, LLC', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Medical Research Institute, LLC', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85381', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Onyx Clinical Research', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Del Sol Research Management, LLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Preferred Research Partners, Inc.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72212', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Applied Research Center of Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72117', 'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Gastroenterology - North Little Rock', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'zip': '90201', 'city': 'Bell Gardens', 'state': 'California', 'country': 'United States', 'facility': 'Alliance Research Institute - Bell Gardens', 'geoPoint': {'lat': 33.96529, 'lon': -118.15146}}, {'zip': '91303', 'city': 'Canoga Park', 'state': 'California', 'country': 'United States', 'facility': 'Hope Clinical Research LLC', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'zip': '91304', 'city': 'Canoga Park', 'state': 'California', 'country': 'United States', 'facility': 'Alliance Research Institute, LLC', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Erick H. 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