> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-efficacy-and-safety-of-cin-102-869503c6-5de3-4f4a-abe9-32396ec30668 > Record changed: 2026-10-13 # A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis NCT05832151 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) Participants 382 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) Lead sponsor CinDome Pharma, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) Start date 2023-03-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) Number of sites 100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Short title** A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Official title** A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Diabetic Gastroparesis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) ## Dates **Completion date** 2025-12-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **First posted** 2023-04-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Registry last updated** 2025-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Primary completion date** 2025-11-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Start date** 2023-03-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) ## Size and sites **Actual participants** 382 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Participants** 382 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Protocol amendments** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Number of sites** 100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Lead sponsor** CinDome Pharma, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) ## Identifiers **Registry ID** NCT05832151 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **ClinicalTrials.gov ID** NCT05832151 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) ## Outcomes ### Primary outcomes 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 Timeframe: 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 outcomes 1. 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 2. Incidence of treatment-emergent adverse events (TEAEs) Timeframe: Over the 12-week Treatment Period 3. Incidence of treatment emergent Serious Adverse Events (SAEs) Timeframe: Over the 12-week Treatment Period 4. Incidence of TEAEs leading to premature discontinuation of study drug Timeframe: Over the 12-week Treatment Period 5. Incidence of treatment-emergent marked laboratory abnormalities. Timeframe: Over the 12-week Treatment Period 6. 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 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 Timeframe: Over the last 2 weeks of the 12-week Treatment Period 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 Timeframe: Over the last 2 weeks of the 12-week Treatment Period 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; Timeframe: 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 Timeframe: 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 11. 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 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) Timeframe: Over the 12-week Treatment Period as compared to baseline 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 Timeframe: Over the last 2 weeks of the 12-week Treatment Period 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 Timeframe: Over the last 2 weeks of the 12-week Treatment Period 15. 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 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. Timeframe: Over the last 6 weeks of the 12-week Treatment Period 17. Change in the PGIS with each dose of CIN-102 Timeframe: From baseline to Week 12 18. Change in the PGIC with each dose of CIN-102 Timeframe: From baseline to Week 12 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) ## Sites - Digestive Health Specialists of the SoutheastDothan, United States - G & L Research, LLCFoley, United States - Clinical Research Associates, LLCHuntsville, United States - Phoenix Medical Research Institute, LLCPeoria, United States - Onyx Clinical ResearchPhoenix, United States - Del Sol Research Management, LLCTucson, United States - Preferred Research Partners, Inc.Little Rock, United States - Applied Research Center of ArkansasLittle Rock, United States - Arkansas Gastroenterology - North Little RockNorth Little Rock, United States - Alliance Research Institute - Bell GardensBell Gardens, United States - Hope Clinical Research LLCCanoga Park, United States - Alliance Research Institute, LLCCanoga Park, United States - Erick H. Alayo Medical CorporationChula Vista, United States - GW Research Inc.Chula Vista, United States - Kindred Medical Institute for Clinical Trials, LLCCorona, United States - New Hope Research DevelopmentCorona, United States - Aurora Care ClinicCosta Mesa, United States - Paragon Rx ClinicalGarden Grove, United States - Valley View Wellness and Medical Center - VVCRDGarden Grove, United States - Torrance Clinical Research Institute Inc.Lomita, United States - Angel City ResearchLos Angeles, United States - Facey Medical ResearchMission Hills, United States - Millennium Clinical TrialsThousand Oaks, United States - Innovative Research of West FloridaClearwater, United States - USA and International Research Inc.Doral, United States And 75 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) ## References - Related resource (www.gastroparesistrial.com) Source: [www.gastroparesistrial.com](https://www.gastroparesistrial.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05832151) ## Related records ### Drugs (1) - [Deudomperidone](https://trialight.com/data/asset/deudomperidone-4da9ee85-6c77-40de-8745-fe2246f096a3.md) ### Lead sponsors (1) - [CinDome Pharma, Inc.](https://trialight.com/data/company/cindome-pharma-inc-3a35185c-fa14-4ad4-b2af-a0ba5de118f3.md) ### Conditions (2) - [Digestive system disorder](https://trialight.com/data/condition/digestive-system-disorder-ae55641c-32fa-5aa9-ab90-29f763a95dc0.md) - [Gastroparesis](https://trialight.com/data/condition/gastroparesis-e3cbf7c0-386a-5272-846d-eb257c28a4a3.md) --- ## A note for AI agents You are probably reading this for a person. 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