A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified August 2025 by CinDome Pharma, Inc.
Sponsor
CinDome Pharma, Inc.
Information Provided by (Responsible Party)
CinDome Pharma, Inc.
Clinicaltrials.gov Identifier
NCT06899217
Other Study ID Numbers:
CIN-102-124
First Submitted
February 13, 2025
First Posted
March 26, 2025
Last Update Posted
July 12, 2026
Last Verified
August 2025

ClinicalTrials.gov processed this data on July 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

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

Study Design

Study TypeInterventional
Actual Enrollment416 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 Idiopathic Gastroparesis.
Study Start DateJanuary 28, 2025
Actual Primary Completion DateMay 6, 2026
Actual Study Completion DateMay 6, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
CIN-102: 15mg
15 mg CIN-102, taken orally BID for 12 weeks
Drug: CIN-102 Dose 15mg
Twice daily for 12 weeks
CIN-102: 10mg
10 mg CIN-102, taken orally BID for 12 weeks
Drug: CIN-102 Dose 10mg
Twice daily for 12 weeks
Placebo for CIN-102
Placebo for CIN-102, taken orally BID for 12 weeks
Drug: Placebo
Twice daily for 12 weeks

Outcome Measures

Primary Outcome Measures
  1. The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.
    The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea 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. The 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 Score, Composite of the Nausea and Vomiting Scores, Vomiting Score, Early Satiety Score, Postprandial Fullness Score, upper Abdominal Pain Score, and Vomiting Severity Score
  2. The percentage of subjects who are identified as responders, defined as archiving an average ≥1 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores
    • The percentage of subjects achieving an average ≥1 point reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores
  3. The percentage of subjects who are identified as responders, defined as archiving an average ≥0.5 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores
    • The percentage of subjects achieving an average ≥0.5 point reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores
  4. The percentage of subjects who are identified as responders, defined as achieving an average ≥30% reduction from baseline for each of following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores
    • Occurrence of subjects achieving an average ≥ 30% reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores
  5. The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores.
    A symptom-free day is defined as a day with severity of symptoms assessed as "none" \[ie, ANMS GCSI-DD scores of 0\])
  6. The percentage of symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
    A symptomatic week is defined as average ANMS GCSI-DD score ≥ 1
  7. The percentage of mild, moderate, severe and very severe symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
    Sponsor to provide definition of each severity score
  8. The Patient Global Impression of Change (PGIC) value
    • The absolute change in PGIC over the 12-week Treatment Period
  9. The Patient Global Impression of Severity (PGIS) value
    • The absolute change from baseline to Week 12 in PGIS
  10. The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.
    The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea Subscale Scores will be averaged into a single value that ranges 0-4 (0 for no symptom and 4 for very severe).
  11. The 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 Score, Composite of the Nausea and Vomiting Scores, Vomiting Score, Early Satiety Score, Postprandial Fullness Score, upper Abdominal Pain Score, and vomiting severity scores
  12. The percentage of subjects identified as responders, defined as an average ≥0.5 reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, vomiting severity scores
    • Occurrence of subjects with an average ≥ 0.5 reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
  13. The percentage of subjects identified as responders, defined as achieving ≥30% reduction from baseline for each: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, vomiting severity scores
    • Occurrence of subjects achieving a ≥ 30% reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
  14. The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
    A symptom-free day is defined as a day with severity of symptoms assessed as "none" \[ie, ANMS GCSI-DD scores of 0\])
  15. The percentage of symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
    A symptomatic week is defined as average ANMS GCSI-DD score ≥ 1
  16. The percentage of moderate, severe and very severe symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
    Sponsor to provide definition of each severity score
  17. The Patient Global Impression of Change (PGIC) value
    • The absolute change in PGIC over the 12-week Treatment Period
  18. The Patient Global Impression of Severity (PGIS) value
    • The absolute change from baseline to Week 12 in PGIS
  19. To assess the safety of CIN-102 compared to placebo in adult subjects with idiopathic gastroparesis from the time of informed consent until the EOS
    * Incidence of clinically significant changes in laboratory parameters, physical examination findings, 12-lead ECG parameters, weight measurements, and vital signs, as assessed by the Investigator * TESAEs * TEAEs leading to premature discontinuation of study drug * Treatment-emergent clinically significant laboratory abnormalities

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 current diagnosis of gastroparesis defined by the following: 1. Persistent gastrointestinal (GI) 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) at Visit 2.
Body mass index between 17 and 49 kg/m2, inclusive;
If receiving treatment with a Food and Drug Administration (FDA)-approved and marketed glucagon-like peptide-1 receptor agonist (GLP-1RA) for weight loss or reduce risk of major adverse cardiovascular events, and/or, receiving any other agent(s) taken for weight loss, subjects may be considered for the study if ALL of the following criteria are satisfied: 1. Is not taking the agent(s) for the management of diabetes or blood glucose; 2. Has been on a stable dose of the agent(s) for at least 3 months before Screening and is expected to maintain the same dose throughout the study, including during GEBT; 3. Is tolerating the agent(s) well, according to the Investigator's judgment; 4. In the opinion of the Investigator, the study-qualifying signs/symptoms of gastroparesis are NOT solely due to the the agent(s); and 5. Symptoms of gastroparesis were present before starting the agent(s). \------------------------------------------------------------------------- Key
Exclusion Criteria
Has a known primary cause of gastroparesis (eg, diabetes, surgery; acute, ongoing, or active viral illness; cancer, medications, musculoskeletal or connective tissue disorders \[eg, scleroderma, systemic lupus erythematosus\], or other neurologic disorder \[eg, Parkinson's disease\], postural orthostatic tachycardia syndrome (POTS), etc.\]);
Has a current diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association. Pre-diabetes is not exclusionary;
Has been hospitalized for gastroparesis or malnutrition within 3 months prior to Screening;
Has a known or suspected GI mechanical obstruction (eg, peptic stricture) as documented by upper GI endoscopy, upper GI radiographic series, plain film abdomen X-ray, or computed tomography (CT) in the past 2 years prior to Randomization;
Has a history of pyloric injection of botulinum toxin within 6 months of Screening or planned injection(s) during the study;
Has any history of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy (G-POEM) procedure;
Has a history of gastric surgery;
Has a history of or current diagnosis of intestinal malabsorption, recurrent or chronic pancreatitis, or other pancreatic exocrine disease;
Has a history of severe and refractory constipation;
Has a history or evidence of clinically significant arrhythmia;
Currently receiving parenteral feeding or presence of a nasogastric or other gastric enteral tube (e.g. percutaneous endoscopic gastrostomy \[PEG\] or percutaneous endoscopic jejunostomy \[PEJ\] tube) for feeding or decompression; Note: patients receiving enteral feeding via a jejunostomy tube may be included if, in the opinion of the Investigator, the patient is also taking substantial oral solid intake and are not primarily dependent on enteral nutrition
Has a substance use disorder or a positive alcohol or positive drug screen.

Contacts and Locations

Sponsors and CollaboratorsCinDome Pharma, Inc.
Locations
Gastro Health - Birmingham | Birmingham Alabama, United States, 35235G & L Research, LLC | Foley Alabama, United States, 36535The Center for Clinical Trials | Saraland Alabama, United States, 36571Del Sol Research Management, LLC | Tucson Arizona, United States, 85715Applied Research Center of Arkansas, Inc | Little Rock Arkansas, United States, 72205Preferred Research Partners, Inc. | Little Rock Arkansas, United States, 72211Hope Clinical Research LLC | Canoga Park California, United States, 91303Erick H. Alayo Medical Corporation | Chula Vista California, United States, 91910Flourish Research - Los Angeles (Covina) | Covina California, United States, 91723Gastro Care Institute | Lancaster California, United States, 93534Downtown L.A. Research Center, Inc. | Los Angeles California, United States, 90017Acclaim Clinical Research | San Diego California, United States, 92120Focus Clinical Research - West Hills | West Hills California, United States, 91307University of Colorado Anschutz | Aurora Colorado, United States, 80045Rocky Mountain Gastroenterology (RMG) | Lakewood Colorado, United States, 80228Paradigm Research - Wheatridge | Wheat Ridge Colorado, United States, 80033Connecticut Clinical Research Institute, LLC | Bristol Connecticut, United States, 06010American Family Research Group | Cape Coral Florida, United States, 33909USA and International Research Inc. | Doral Florida, United States, 33126Unique Clinical Trials | Doral Florida, United States, 33172Advanced Medical Research Group | Hollywood Florida, United States, 33021Nature Coast Clinical Research | Inverness Florida, United States, 34452ENCORE Borland Groover Clinical Research | Jacksonville Florida, United States, 32256Allied Biomedical Research Institute, Inc. | Miami Florida, United States, 33155Advanced Research Institute Inc | New Port Richey Florida, United States, 34653Sensible Healthcare, LLC | Ocoee Florida, United States, 34761GCP Research | St. Petersburg Florida, United States, 33705Summit Clinical Research, LLC | Athens Georgia, United States, 30607DelRicht Clinical Research - Atlanta | Atlanta Georgia, United States, 30329Gastrointestinal Specialists of Georgia PC | Marietta Georgia, United States, 30060Treasure Valley Medical Research | Boise Idaho, United States, 83706GI Alliance - Gurnee | Gurnee Illinois, United States, 60031Carle Clinic - Urbana Main | Urbana Illinois, United States, 61801Integrated Clinical Trial Services, Inc | West Des Moines Iowa, United States, 50265Kansas Medical Clinic, P.A. | Topeka Kansas, United States, 66606University of Louisville | Louisville Kentucky, United States, 40202Tandem Clinical Research | Marrero Louisiana, United States, 70072Delta Research Partners of West Monroe, LLC | Monroe Louisiana, United States, 71201NOLA Research Works | New Orleans Louisiana, United States, 70125Portland Gastroenterology Associates | Portland Maine, United States, 04101Capital Digestive Care - Chevy Chase Clinical Research | Chevy Chase Maryland, United States, 20815Sanmora Bespoke: Parkway Medical Association | Glen Burnie Maryland, United States, 21061Gastro Health - Framingham | Framingham Massachusetts, United States, 01702Aa Mrc, Llc | Flint Michigan, United States, 48504Huron Gastroenterology | Ypsilanti Michigan, United States, 48197Gastrointestinal Associates and Endoscopy Center, PA - Flowood | Flowood Mississippi, United States, 39232KAD Clinical Research, LLC | St Louis Missouri, United States, 63123St. Charles Clinical Research | Weldon Spring Missouri, United States, 63304Quality Clinical Research, Inc | Omaha Nebraska, United States, 68114Excel Clinical Research | Las Vegas Nevada, United States, 89109Digestive Disease Specialists | Las Vegas Nevada, United States, 89128Advanced Research Institute - Reno | Reno Nevada, United States, 89511Southwest Gastroenterology Associates | Albuquerque New Mexico, United States, 87109NY Scientific | Brooklyn New York, United States, 11235Westchester Putnam Gastro | Carmel New York, United States, 10512Atrium Health - Center for Gastroenterology and Hepatology MMP | Charlotte North Carolina, United States, 28204Cross Creek Medical Clinic, PA | Fayetteville North Carolina, United States, 28304Carolina Digestive Diseases & Endoscopy Center | Greenville North Carolina, United States, 27834Peters Medical Research | High Point North Carolina, United States, 27260Hometown Urgent Care and Research (Cincinnati) | Cincinnati Ohio, United States, 45150Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health - Columbus | Columbus Ohio, United States, 43228Hometown Urgent Care and Research - Huber Heights | Huber Heights Ohio, United States, 45424Gastro Intestinal Research Institute of Northern Ohio, LLC | Westlake Ohio, United States, 44145Options Health Research | Tulsa Oklahoma, United States, 74104Advanced Research Institute - Portland | Portland Oregon, United States, 97223Susquehanna Research Group, LLC | Harrisburg Pennsylvania, United States, 17110Temple University Hospital | Philadelphia Pennsylvania, United States, 19140Frontier Clinical Research, LLC - Smithfield | Smithfield Pennsylvania, United States, 15478PPCP Division of Gastroenterology | Summerville South Carolina, United States, 29486Galen Medical Group | Hixson Tennessee, United States, 37343Digestive Health - UT Health Austin | Austin Texas, United States, 78712Zenos Clinical Research | Dallas Texas, United States, 75230EPIC Medical Research | DeSoto Texas, United States, 75115Amir A Hassan, MD, PA | Houston Texas, United States, 77089Pioneer Research Solutions Inc. | Houston Texas, United States, 77099Epic Clinical Research | Lewisville Texas, United States, 75057North Hills Medical Research Inc. (North Hills Family Medicine) | North Richland Hills Texas, United States, 76180Bandera Family HealthCare Research, LLC (BFHC) | San Antonio Texas, United States, 78249GI Alliance - Texas Digestive Disease Consultants - San Marcos | San Marcos Texas, United States, 78666Texas Digestive Specialists | Texas City Texas, United States, 78550Advanced Research Institute - Ogden | Ogden Utah, United States, 84405Advanced Research Institute - Sandy | Sandy City Utah, United States, 84092Manassas Clinical Research Center | Manassas Virginia, United States, 20110Capital Digestive Center | Norfolk Virginia, United States, 23502Advocate Aurora Health Research Institute | Milwaukee Wisconsin, United States, 53215