A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified July 2025 by CinDome Pharma, Inc.
Sponsor
CinDome Pharma, Inc.
Information Provided by (Responsible Party)
CinDome Pharma, Inc.
Clinicaltrials.gov Identifier
NCT05832151
Other Study ID Numbers:
CIN-102-123
First Submitted
March 15, 2023
First Posted
April 26, 2023
Last Update Posted
December 16, 2025
Last Verified
July 2025

ClinicalTrials.gov processed this data on December 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Diabetic Gastroparesis
Drug: CIN-102 Dose 15mg or 10mgDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment382 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Diabetic Gastroparesis
Study Start DateMarch 26, 2023
Actual Primary Completion DateNovember 13, 2025
Actual Study Completion DateDecember 11, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
CIN-102: Dose 15mg or 10mg
CIN-102, Dose 15 mg or 10 mg, twice daily for 12 weeks
Drug: CIN-102 Dose 15mg or 10mg
2 capsules twice daily for 12 weeks
Placebo
Placebo for CIN-102, twice daily for 12 weeks
Drug: Placebo
2 capsules twice daily for 12 weeks

Outcome Measures

Primary Outcome Measures
  1. 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
    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
  1. Incidence of clinically significant changes, in the Investigator's opinion, in laboratory parameters, physical examination findings, 12-lead ECG parameters, weight measurement.
  2. Incidence of treatment-emergent adverse events (TEAEs)
  3. Incidence of treatment emergent Serious Adverse Events (SAEs)
  4. Incidence of TEAEs leading to premature discontinuation of study drug
  5. Incidence of treatment-emergent marked laboratory abnormalities.
  6. Percentage of responders who demonstrate an average ≥0.5 reduction from baseline on the ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores
  7. Percentage of subjects achieving a ≥30% reduction from baseline on a composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores
  8. 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
    Symptomatic days defined as \>mild (ANMS GCSI-DD scores \>2)
  9. 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;
  10. 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
    Composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores
  11. Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline
    Based on the average ANMS GCSI-DD Total and Sub-Scale Scores
  12. 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)
  13. 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
  14. 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
  15. The change in the ANMS GSCI-DD Total Score and a composite of gastroparesis-related symptoms among subjects receiving GLP-1RA;
  16. 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.
  17. Change in the PGIS with each dose of CIN-102
  18. Change in the PGIC with each dose of CIN-102

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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. Key
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.

Contacts and Locations

Sponsors and CollaboratorsCinDome Pharma, Inc.
Locations
Digestive Health Specialists of the Southeast | Dothan Alabama, United States, 36305G & L Research, LLC | Foley Alabama, United States, 36535Clinical Research Associates, LLC | Huntsville Alabama, United States, 35801Phoenix Medical Research Institute, LLC | Peoria Arizona, United States, 85381Onyx Clinical Research | Phoenix Arizona, United States, 85381Del Sol Research Management, LLC | Tucson Arizona, United States, 85715Preferred Research Partners, Inc. | Little Rock Arkansas, United States, 72211Applied Research Center of Arkansas | Little Rock Arkansas, United States, 72212Arkansas Gastroenterology - North Little Rock | North Little Rock Arkansas, United States, 72117Alliance Research Institute - Bell Gardens | Bell Gardens California, United States, 90201Hope Clinical Research LLC | Canoga Park California, United States, 91303Alliance Research Institute, LLC | Canoga Park California, United States, 91304Erick H. Alayo Medical Corporation | Chula Vista California, United States, 91910GW Research Inc. | Chula Vista California, United States, 91910Kindred Medical Institute for Clinical Trials, LLC | Corona California, United States, 92879New Hope Research Development | Corona California, United States, 92882Aurora Care Clinic | Costa Mesa California, United States, 92627Paragon Rx Clinical | Garden Grove California, United States, 92840Valley View Wellness and Medical Center - VVCRD | Garden Grove California, United States, 92845Torrance Clinical Research Institute Inc. | Lomita California, United States, 09717Angel City Research | Los Angeles California, United States, 90010Facey Medical Research | Mission Hills California, United States, 11333Millennium Clinical Trials | Thousand Oaks California, United States, 91360Innovative Research of West Florida | Clearwater Florida, United States, 33756USA and International Research Inc. | Doral Florida, United States, 33126Advanced Medical Research Group | Hollywood Florida, United States, 33021Nature Coast Clinical Research | Inverness Florida, United States, 34452ClinCloud LLC | Maitland Florida, United States, 32751A+ Research Inc | Miami Florida, United States, 33144International Research Associates LLC - Breton | Miami Florida, United States, 33183Advanced Research Institute Inc | New Port Richey Florida, United States, 34653Gastroenterology of Greater Orlando | Orange City Florida, United States, 32763Tandem Clinical Research - Viera | Viera Florida, United States, 32940Summit Clinical Research, LLC | Athens Georgia, United States, 30607Atlanta Center for Gastroenterology P.C. | Decatur Georgia, United States, 30033Medisphere Medical Research Center | Evansville Indiana, United States, 47714Lutheran Medical Group | Fort Wayne Indiana, United States, 46804University of Kansas Medical Center (KUMC) | Kansas City Kansas, United States, 66160DelRicht Clinical Research - Overland Park | Overland Park Kansas, United States, 66209Kansas Medical Clinic, P.A. | Topeka Kansas, United States, 66606Alliance for Multispecialty Research - Wichita West | Wichita Kansas, United States, 67205University of Louisville | Louisville Kentucky, United States, 40202DelRicht Clinical Research - Louisville | Louisville Kentucky, United States, 40205Delta Research Partners | Bastrop Louisiana, United States, 71201Tandem Clinical Research GI - Houma | Houma Louisiana, United States, 70363Tandem Clinical Research | Marrero Louisiana, United States, 70072Tandem Clinical Research GI - Metairie | Metairie Louisiana, United States, 70006Clinical Research Institute of Michigan, LLC | Chesterfield Michigan, United States, 48047Aa Mrc, Llc | Flint Michigan, United States, 48504Clinical Research Institute of Michigan, LLC - Troy | Troy Michigan, United States, 48098Gastroenterology Associates of Western Michigan | Wyoming Michigan, United States, 49519Kansas City Research Institute | Kansas City Missouri, United States, 64131Washington University School of Medicine | St Louis Missouri, United States, 63110St. Charles Clinical Research | Weldon Spring Missouri, United States, 63304Montana Medical Research, Inc. | Missoula Montana, United States, 59808American Institute of Medical Research | Las Vegas Nevada, United States, 89123Digestive Disease Specialists | Las Vegas Nevada, United States, 89128Allied Health Clinical Research Organization, LLC (AHCRO) - Englewood | Englewood New Jersey, United States, 07631Allied Health Clinical Research Organization, LLC (AHCRO) - Freehold | Freehold New Jersey, United States, 07728Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson | Jackson New Jersey, United States, 08527NY Scientific | Brooklyn New York, United States, 11235Smart Medical Research | Brooklyn New York, United States, 11372Velocity Clinical Research - Syracuse | East Syracuse New York, United States, 13057Tandem Clinical Research GI- New York | New York New York, United States, 10033A1 Clinical Network | Richmond Hill New York, United States, 11418OnSite Clinical Solutions, LLC | Charlotte North Carolina, United States, 28144Atrium Health - Center for Digestive Health | Charlotte North Carolina, United States, 28204Research Carolina Elite, LLC | Denver North Carolina, United States, 28037Coastal Research Institute, LLC | Fayetteville North Carolina, United States, 28304Cross Creek Medical, PA | Fayetteville North Carolina, United States, 28304Triad Clinical Trials LLC | Greensboro North Carolina, United States, 27410Peters Medical Research | High Point North Carolina, United States, 27260Carolina's GI Research | Raleigh North Carolina, United States, 27612Cleveland Clinic | Cleveland Ohio, United States, 44195Remington Davis, Inc. | Columbus Ohio, United States, 43215DelRicht Clinical Research - Cincinnati | Mason Ohio, United States, 45040Northshore Gastroenterology Research, LLC | Westlake Ohio, United States, 44145Options Health Research | Tulsa Oklahoma, United States, 74104Velocity Clinical Research | Medford Oregon, United States, 97504Susquehanna Research Group, LLC | Harrisburg Pennsylvania, United States, 17110Galen Medical Group - Downtown Gastroenterology Location | Chattanooga Tennessee, United States, 37343WR ClinSearch | Chattanooga Tennessee, United States, 37421DelRicht Clinical Research - Nashville | Henderson Tennessee, United States, 37075North Hills Medical Research Inc. (North Hills Familiy Medicine) | Arlington Texas, United States, 76012Zenos Clinical Research | Dallas Texas, United States, 75230Texas Gastro Research, LLC | El Paso Texas, United States, 10908Houston Methodist Research Institute | Houston Texas, United States, 77030Amir A Hassan, MD, PA | Houston Texas, United States, 77089Care and Cure Clinic | Houston Texas, United States, 77090Pioneer Research Solutions Inc. | Houston Texas, United States, 77099Epic Clinical Research | Lewisville Texas, United States, 75057Texas Tech University Health Sciences Center | Lubbock Texas, United States, 79905Biopharma Informatic, LLC | McAllen Texas, United States, 78503DelRicht Clinical Research - McKinney | McKinney Texas, United States, 75070Gastroenterology Research of San Antonio | San Antonio Texas, United States, 78229A1 Clinical Network | Spring Texas, United States, 77386HP Clinical Research (Val R. Hansen) | Bountiful Utah, United States, 84010Velocity Clinical Research - Salt Lake City | West Jordan Utah, United States, 84065Manassas Clinical Research Center | Manassas Virginia, United States, 20110Wisconsin Center for Advanced Research | Milwaukee Wisconsin, United States, 53215