A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis
Key facts
- Where
- Arlington, Athens, Bastrop, Bell Gardens, Bountiful, Brooklyn, Canoga Park, Charlotte, Chattanooga, Chesterfield, Chula Vista, Clearwater, Cleveland, Columbus, Corona, Costa Mesa, Dallas, Decatur, Denver, Doral, Dothan, East Syracuse, El Paso, Englewood, Evansville, Fayetteville, Flint, Foley, Fort Wayne, Freehold, Garden Grove, Greensboro, Harrisburg, Henderson, High Point, Hollywood, Houma, Houston, Huntsville, Inverness, Jackson, Kansas City, Las Vegas, Lewisville, Little Rock, Lomita, Los Angeles, Louisville, Lubbock, Maitland, Manassas, Marrero, Mason, McAllen, McKinney, Medford, Metairie, Miami, Milwaukee, Mission Hills, Missoula, New Port Richey, New York, North Little Rock, Orange City, Overland Park, Peoria, Phoenix, Raleigh, Richmond Hill, San Antonio, Spring, St Louis, Thousand Oaks, Topeka, Troy, Tucson, Tulsa, Viera, Weldon Spring, West Jordan, Westlake, Wichita, and Wyoming, United StatesSee the 100 sites
- Phase
- Phase 2
Where in United States
- North Hills Medical Research Inc. (North Hills Familiy Medicine)Arlington, United StatesNo longer taking part
- Summit Clinical Research, LLCAthens, United StatesNo longer taking part
- Delta Research PartnersBastrop, United StatesNo longer taking part
- Alliance Research Institute - Bell GardensBell Gardens, United StatesNo longer taking part
- HP Clinical Research (Val R. Hansen)Bountiful, United StatesNo longer taking part
- NY ScientificBrooklyn, United StatesNo longer taking part
- Smart Medical ResearchBrooklyn, United StatesNo longer taking part
- Alliance Research Institute, LLCCanoga Park, United StatesNo longer taking part
- Hope Clinical Research, LLCCanoga Park, United StatesNo longer taking part
- Atrium Health Center for Digestive HealthCharlotte, United StatesNo longer taking part
- Onsite Clinical Solutions, LLCCharlotte, United StatesNo longer taking part
- Galen Medical Group - Downtown Gastroenterology LocationChattanooga, United StatesNo longer taking part
- WR-ClinSearchChattanooga, United StatesNo longer taking part
- Clinical Research Institute of Michigan, LLCChesterfield, United StatesNo longer taking part
- Erick H. Alayo Medical CorporationChula Vista, United StatesNo longer taking part
- GW Research IncChula Vista, United StatesNo longer taking part
- Innovative Research of West FloridaClearwater, United StatesNo longer taking part
- Cleveland ClinicCleveland, United StatesNo longer taking part
- Remington Davis, Inc.Columbus, United StatesNo longer taking part
- Kindred Medical Institute for Clinical Trials, LLCCorona, United StatesNo longer taking part
- New Hope Research DevelopmentCorona, United StatesNo longer taking part
- Aurora Care ClinicCosta Mesa, United StatesNo longer taking part
- Zenos Clinical ResearchDallas, United StatesNo longer taking part
- Atlanta Center For Gastroenterology, P.C.Decatur, United StatesNo longer taking part
- Research Carolina Elite LLCDenver, United StatesNo longer taking part
- USA and International Research Inc.Doral, United StatesNo longer taking part
- Digestive Health Specialists of the SoutheastDothan, United StatesNo longer taking part
- Velocity Clinical Research, SyracuseEast Syracuse, United StatesNo longer taking part
- Texas Gastro Research, LLCEl Paso, United StatesNo longer taking part
- Allied Health Clinical Research Organization, LLC (AHCRO) - EnglewoodEnglewood, United StatesNo longer taking part
- Medisphere Medical Research CenterEvansville, United StatesNo longer taking part
- Coastal Research Institute, LLCFayetteville, United StatesNo longer taking part
- Cross Creek Medical, PAFayetteville, United StatesNo longer taking part
- Aa Mrc LlcFlint, United StatesNo longer taking part
- G & L Research LLCFoley, United StatesNo longer taking part
- Lutheran Medical GroupFort Wayne, United StatesNo longer taking part
- Allied Health Clinical Research Organization, LLC (AHCRO) - FreeholdFreehold, United StatesNo longer taking part
- Paragon Rx ClinicalGarden Grove, United StatesNo longer taking part
- Valley View Wellness and Medical Center - VVCRDGarden Grove, United StatesNo longer taking part
- Triad Clinical Trials, LLCGreensboro, United StatesNo longer taking part
- Susquehanna Research Group, LLCHarrisburg, United StatesNo longer taking part
- DelRicht Clinical Research - NashvilleHenderson, United StatesNo longer taking part
- Peters Medical ResearchHigh Point, United StatesNo longer taking part
- Advanced Medical Research GroupHollywood, United StatesNo longer taking part
- Tandem Clinical Research GI - HoumaHouma, United StatesNo longer taking part
- Amir A Hassan, MD, PAHouston, United StatesNo longer taking part
- Care and Cure ClinicHouston, United StatesNo longer taking part
- Houston Methodist Research InstituteHouston, United StatesNo longer taking part
- Pioneer Research Solutions, Inc.Houston, United StatesNo longer taking part
- Clinical Research Associates LLCHuntsville, United StatesNo longer taking part
- Nature Coast Clinical ResearchInverness, United StatesNo longer taking part
- Allied Health Clinical Research Organization, LLC (AHCRO) - JacksonJackson, United StatesNo longer taking part
- Kansas City Research InstituteKansas City, United StatesNo longer taking part
- University of Kansas Medical Center (KUMC)Kansas City, United StatesNo longer taking part
- American Institute of Medical ResearchLas Vegas, United StatesNo longer taking part
- Digestive Disease SpecialistsLas Vegas, United StatesNo longer taking part
- Epic Clinical ResearchLewisville, United StatesNo longer taking part
- Applied Research Center of ArkansasLittle Rock, United StatesNo longer taking part
- Preferred Research Partners, IncLittle Rock, United StatesNo longer taking part
- Torrance Clinical Research Institute, Inc.Lomita, United StatesNo longer taking part
- Angel City ResearchLos Angeles, United StatesNo longer taking part
- DelRicht Clinical Research - LouisvilleLouisville, United StatesNo longer taking part
- University of LouisvilleLouisville, United StatesNo longer taking part
- Texas Tech University Health Sciences CenterLubbock, United StatesNo longer taking part
- ClinCloud, LLCMaitland, United StatesNo longer taking part
- Manassas Clinical Research CenterManassas, United StatesNo longer taking part
- Tandem Clinical ResearchMarrero, United StatesNo longer taking part
- DelRicht Clinical Research - CincinnatiMason, United StatesNo longer taking part
- Biopharma Informatic, LLCMcAllen, United StatesNo longer taking part
- DelRicht Clinical Research - McKinneyMcKinney, United StatesNo longer taking part
- Velocity Clinical ResearchMedford, United StatesNo longer taking part
- Tandem Clinical Research GI - MetairieMetairie, United StatesNo longer taking part
- A+ Research, Inc.Miami, United StatesNo longer taking part
- International Research Associates LLC - BretonMiami, United StatesNo longer taking part
- Wisconsin Center for Advanced ResearchMilwaukee, United StatesNo longer taking part
- Facey Medical ResearchMission Hills, United StatesNo longer taking part
- Montana Medical Research, IncMissoula, United StatesNo longer taking part
- Advanced Research Institute, Inc.New Port Richey, United StatesNo longer taking part
- Tandem Clinical Research GI - New YorkNew York, United StatesNo longer taking part
- Arkansas Gastroenterology - North Little RockNorth Little Rock, United StatesNo longer taking part
- Gastroenterology of Greater OrlandoOrange City, United StatesNo longer taking part
- DelRicht Clinical Research - Overland ParkOverland Park, United StatesNo longer taking part
- Phoenix Medical Research Institute, LLCPeoria, United StatesNo longer taking part
- Onyx Clinical ResearchPhoenix, United StatesNo longer taking part
- Carolina's GI ResearchRaleigh, United StatesNo longer taking part
- A1 Clinical NetworkRichmond Hill, United StatesNo longer taking part
- Gastroenterology Research of San AntonioSan Antonio, United StatesNo longer taking part
- A1 Clinical NetworkSpring, United StatesNo longer taking part
- Washington University School of MedicineSt Louis, United StatesNo longer taking part
- Millennium Clinical TrialsThousand Oaks, United StatesNo longer taking part
- Kansas Medical Clinic, P.A.Topeka, United StatesNo longer taking part
- Clinical Research Institute of Michigan, LLC - TroyTroy, United StatesNo longer taking part
- Del Sol Research Management, LLCTucson, United StatesNo longer taking part
- Options Health ResearchTulsa, United StatesNo longer taking part
- Tandem Clinical Research - VieraViera, United StatesNo longer taking part
- St. Charles Clinical ResearchWeldon Spring, United StatesNo longer taking part
- Velocity Clinical Research, Salt Lake CityWest Jordan, United StatesNo longer taking part
- Northshore Gastroenterology Research, LLCWestlake, United StatesNo longer taking part
- Alliance for Multispecialty Research-Wichita WestWichita, United StatesNo longer taking part
- Gastroenterology Associates of Western MichiganWyoming, United StatesNo longer taking part
Trial details
- Who runs it
- CinDome Pharma, Inc.
- Trial code
- NCT05832151
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Diabetic Gastroparesis
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
Inclusion: 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.
Exclusion: Has been hospitalized within 3 months prior to Visit 1 for diabetic gastroparesis and/or diabetic ketoacidosis and/or malnutrition; Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression; Positive test for drugs of abuse; 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); History or evidence of clinically significant arrhythmia; History of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy, fundoplication, gastrectomy, vagotomy, or bariatric surgery; Has a known allergy to eggs or spirulina; Pyloric injection of botulinum toxin within 6 months of Screening; Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.