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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.

The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help to decrease nausea severity associated with idiopathic gastroparesis severity in adult subjects.

The main questions it aims to answer are:

• To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with idiopathic gastroparesis compared to a placebo
• To evaluate the safety of CIN-102 when given to patients with idiopathic gastroparesis compared to a placebo

Participants will go through the following schedule:

• Pre-screening (1 visit)

• Screening & Lead-In (1-2 visits)

  • 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.
• Lead-In Period (1 visit)

• 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:

• 15 mg CIN-102, taken orally BID for 12 weeks
• 10 mg CIN-102, taken orally BID for 12 weeks
• Placebo for CIN-102, taken orally BID for 12 weeks

Study Overview

• Status: Active, not recruiting
• Conditions: Idiopathic Gastroparesis
• Intervention / Treatment: Drug: CIN-102 Dose 15mg; Drug: CIN-102 Dose 10mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key 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).

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     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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CIN-102: 15mg; 15 mg CIN-102, taken orally BID for 12 weeks	Drug: CIN-102 Dose 15mg; Twice daily for 12 weeks
Experimental: CIN-102: 10mg; 10 mg CIN-102, taken orally BID for 12 weeks	Drug: CIN-102 Dose 10mg; Twice daily for 12 weeks
Placebo Comparator: Placebo for CIN-102; Placebo for CIN-102, taken orally BID for 12 weeks	Drug: Placebo; Twice daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline
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	Over the 12-week Treatment Period
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	Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline
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	Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period
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	Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period
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	Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period
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])	Over the 12-week Treatment Period
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	Over the 12-week Treatment Period
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	Over the 12-week Treatment Period
The Patient Global Impression of Change (PGIC) value	• The absolute change in PGIC over the 12-week Treatment Period	Over the 12-week Treatment Period
The Patient Global Impression of Severity (PGIS) value	• The absolute change from baseline to Week 12 in PGIS	From baseline to Week 12
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	Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline
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	Over the last 6 weeks of the 12-week Treatment Period
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	Over the final 6 weeks of the 12-week Treatment Period
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])	Over the final 6 weeks of the 12-week Treatment Period
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	Over the final 6 weeks of the 12-week Treatment Period
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	Over the final 6 weeks of the 12-week Treatment Period
The Patient Global Impression of Change (PGIC) value	• The absolute change in PGIC over the 12-week Treatment Period	Over the final 6 weeks of the 12-week Treatment Period
The Patient Global Impression of Severity (PGIS) value	• The absolute change from baseline to Week 12 in PGIS	Over the final 6 weeks of the 12-week Treatment Period

Collaborators and Investigators

• Sponsor: CinDome Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: March 21, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Nausea; Vomiting; Gastroparesis; Abdominal pain; Bloating; Gastric motility; Early satiety; Delayed gastric emptying; Stomach pain; Idiopathic Gastroparesis; Dysmotility; Epigastric pain; Dopamine receptor antagonist; Post-prandial fullness; Gastric statis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Abdominal Pain; Nausea; Vomiting; Gastroparesis; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: CIN-102-124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No