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

Last updated: July 10, 2026
Sponsor: CinDome Pharma, Inc.
Overall Status: Completed

Phase

2

Condition

Colic

Ulcerative Colitis (Pediatric)

Dysmenorrhea (Painful Periods)

Treatment

CIN-102 Dose 15mg

Placebo

CIN-102 Dose 10mg

Clinical Study ID

NCT06899217
CIN-102-124
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 theInvestigator, are consistent with gastroparesis within 6 months prior toScreening; and

  2. Documented delayed gastric emptying as determined by gastric emptying breathtest (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 andmarketed glucagon-like peptide-1 receptor agonist (GLP-1RA) for weight loss orreduce risk of major adverse cardiovascular events, and/or, receiving any otheragent(s) taken for weight loss, subjects may be considered for the study if ALL ofthe 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 beforeScreening 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 ofgastroparesis are NOT solely due to the the agent(s); and

  5. Symptoms of gastroparesis were present before starting the agent(s).


Exclusion

Key Exclusion Criteria:

  • Has a known primary cause of gastroparesis (eg, diabetes, surgery; acute, ongoing,or active viral illness; cancer, medications, musculoskeletal or connective tissuedisorders [eg, scleroderma, systemic lupus erythematosus], or other neurologicdisorder [eg, Parkinson's disease], postural orthostatic tachycardia syndrome (POTS), etc.]);

  • Has a current diagnosis of Type 1 or Type 2 diabetes, according to the AmericanDiabetes Association. Pre-diabetes is not exclusionary;

  • Has been hospitalized for gastroparesis or malnutrition within 3 months prior toScreening;

  • Has a known or suspected GI mechanical obstruction (eg, peptic stricture) asdocumented by upper GI endoscopy, upper GI radiographic series, plain film abdomenX-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 Screeningor planned injection(s) during the study;

  • Has any history of pyloroplasty, pyloromyotomy, or gastric peroral endoscopicmyotomy (G-POEM) procedure;

  • Has a history of gastric surgery;

  • Has a history of or current diagnosis of intestinal malabsorption, recurrent orchronic 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 gastricenteral tube (e.g. percutaneous endoscopic gastrostomy [PEG] or percutaneousendoscopic jejunostomy [PEJ] tube) for feeding or decompression; Note: patientsreceiving enteral feeding via a jejunostomy tube may be included if, in the opinionof the Investigator, the patient is also taking substantial oral solid intake andare not primarily dependent on enteral nutrition

  • Has a substance use disorder or a positive alcohol or positive drug screen.

Study Design

Total Participants: 416
Treatment Group(s): 3
Primary Treatment: CIN-102 Dose 15mg
Phase: 2
Study Start date:
January 29, 2025
Estimated Completion Date:
May 07, 2026

Connect with a study center

  • Gastro Health - Birmingham

    Birmingham, Alabama 35235
    United States

    Site Not Available

  • G & L Research, LLC

    Foley, Alabama 36535
    United States

    Site Not Available

  • The Center for Clinical Trials

    Saraland, Alabama 36571
    United States

    Site Not Available

  • Del Sol Research Management, LLC

    Tucson, Arizona 85715
    United States

    Site Not Available

  • Applied Research Center of Arkansas, Inc

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Applied Research Center of Arkansas, Inc

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Site Not Available

  • Hope Clinical Research LLC

    Canoga Park, California 91303
    United States

    Site Not Available

  • Erick H. Alayo Medical Corporation

    Chula Vista, California 91910
    United States

    Site Not Available

  • Flourish Research - Los Angeles (Covina)

    Covina, California 91723
    United States

    Site Not Available

  • Gastro Care Institute

    Lancaster, California 93534
    United States

    Site Not Available

  • Downtown L.A. Research Center, Inc.

    Los Angeles, California 90017
    United States

    Site Not Available

  • Acclaim Clinical Research

    San Diego, California 92120
    United States

    Site Not Available

  • Focus Clinical Research - West Hills

    West Hills, California 91307
    United States

    Site Not Available

  • University of Colorado Anschutz

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Rocky Mountain Gastroenterology (RMG)

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Paradigm Research - Wheatridge

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • Connecticut Clinical Research Institute, LLC

    Bristol, Connecticut 06010
    United States

    Site Not Available

  • American Family Research Group

    Cape Coral, Florida 33909
    United States

    Site Not Available

  • USA and International Research Inc.

    Doral, Florida 33126
    United States

    Site Not Available

  • Unique Clinical Trials

    Doral, Florida 33172
    United States

    Site Not Available

  • Advanced Medical Research Group

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Nature Coast Clinical Research

    Inverness, Florida 34452
    United States

    Site Not Available

  • ENCORE Borland Groover Clinical Research

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Allied Biomedical Research Institute, Inc.

    Miami, Florida 33155
    United States

    Site Not Available

  • Advanced Research Institute Inc

    New Port Richey, Florida 34653
    United States

    Site Not Available

  • Sensible Healthcare, LLC

    Ocoee, Florida 34761
    United States

    Site Not Available

  • GCP Research

    St. Petersburg, Florida 33705
    United States

    Site Not Available

  • Unique Clinical Trials

    Doral 4153471, Florida 4155751 33172
    United States

    Site Not Available

  • Summit Clinical Research, LLC

    Athens, Georgia 30607
    United States

    Site Not Available

  • DelRicht Clinical Research - Atlanta

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Gastrointestinal Specialists of Georgia PC

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Treasure Valley Medical Research

    Boise, Idaho 83706
    United States

    Site Not Available

  • GI Alliance - Gurnee

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Carle Clinic - Urbana Main

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Integrated Clinical Trial Services, Inc

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • Kansas Medical Clinic, P.A.

    Topeka, Kansas 66606
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Tandem Clinical Research

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Delta Research Partners of West Monroe, LLC

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • NOLA Research Works

    New Orleans, Louisiana 70125
    United States

    Site Not Available

  • Portland Gastroenterology Associates

    Portland, Maine 04101
    United States

    Site Not Available

  • Capital Digestive Care - Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Sanmora Bespoke: Parkway Medical Association

    Glen Burnie, Maryland 21061
    United States

    Site Not Available

  • Gastro Health - Framingham

    Framingham, Massachusetts 01702
    United States

    Site Not Available

  • Aa Mrc, Llc

    Flint, Michigan 48504
    United States

    Site Not Available

  • Huron Gastroenterology

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Gastrointestinal Associates and Endoscopy Center, PA - Flowood

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • KAD Clinical Research, LLC

    St Louis, Missouri 63123
    United States

    Site Not Available

  • St. Charles Clinical Research

    Weldon Spring, Missouri 63304
    United States

    Site Not Available

  • Quality Clinical Research, Inc

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Digestive Disease Specialists

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Excel Clinical Research

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Advanced Research Institute - Reno

    Reno, Nevada 89511
    United States

    Site Not Available

  • Excel Clinical Research

    Las Vegas 5506956, Nevada 5509151 89109
    United States

    Site Not Available

  • Southwest Gastroenterology Associates

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • NY Scientific

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Westchester Putnam Gastro

    Carmel, New York 10512
    United States

    Site Not Available

  • Atrium Health - Center for Gastroenterology and Hepatology MMP

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Cross Creek Medical Clinic, PA

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • Carolina Digestive Diseases & Endoscopy Center

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Peters Medical Research

    High Point, North Carolina 27260
    United States

    Site Not Available

  • Hometown Urgent Care and Research (Cincinnati)

    Cincinnati, Ohio 45150
    United States

    Site Not Available

  • Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health - Columbus

    Columbus, Ohio 43228
    United States

    Site Not Available

  • Hometown Urgent Care and Research - Huber Heights

    Huber Heights, Ohio 45424
    United States

    Site Not Available

  • Gastro Intestinal Research Institute of Northern Ohio, LLC

    Westlake, Ohio 44145
    United States

    Site Not Available

  • Options Health Research

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Advanced Research Institute - Portland

    Portland, Oregon 97223
    United States

    Site Not Available

  • Susquehanna Research Group, LLC

    Harrisburg, Pennsylvania 17110
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Frontier Clinical Research, LLC - Smithfield

    Smithfield, Pennsylvania 15478
    United States

    Site Not Available

  • PPCP Division of Gastroenterology

    Summerville, South Carolina 29486
    United States

    Site Not Available

  • Galen Medical Group

    Hixson, Tennessee 37343
    United States

    Site Not Available

  • Digestive Health - UT Health Austin

    Austin, Texas 78712
    United States

    Site Not Available

  • Zenos Clinical Research

    Dallas, Texas 75230
    United States

    Site Not Available

  • EPIC Medical Research

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Amir A Hassan, MD, PA

    Houston, Texas 77089
    United States

    Site Not Available

  • Pioneer Research Solutions Inc.

    Houston, Texas 77099
    United States

    Site Not Available

  • Epic Clinical Research

    Lewisville, Texas 75057
    United States

    Site Not Available

  • North Hills Medical Research Inc. (North Hills Family Medicine)

    North Richland Hills, Texas 76180
    United States

    Site Not Available

  • Bandera Family HealthCare Research, LLC (BFHC)

    San Antonio, Texas 78249
    United States

    Site Not Available

  • GI Alliance - Texas Digestive Disease Consultants - San Marcos

    San Marcos, Texas 78666
    United States

    Site Not Available

  • Texas Digestive Specialists

    Texas City, Texas 78550
    United States

    Site Not Available

  • Pioneer Research Solutions Inc.

    Houston 4699066, Texas 4736286 77099
    United States

    Site Not Available

  • Advanced Research Institute - Ogden

    Ogden, Utah 84405
    United States

    Site Not Available

  • Advanced Research Institute - Sandy

    Sandy City, Utah 84092
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Site Not Available

  • Capital Digestive Center

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Advocate Aurora Health Research Institute

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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