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New pill may calm diabetic stomach troubles

NCT ID NCT05832151

Symptom relief Sponsor: CinDome Pharma, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called CIN-102 (deudomperidone) to see if it can reduce nausea, vomiting, and other stomach symptoms in adults with diabetic gastroparesis—a condition where the stomach empties too slowly. About 382 participants took either the drug or a placebo twice daily for 12 weeks. Researchers tracked symptom changes using daily diaries and safety checks. The goal was to find a new treatment option for this uncomfortable complication of diabetes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

382 people

The number who actually took part.

Started

Mar 2023

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Digestive System Diseases digestive system disorder gastroparesis Nausea Vomiting

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic gastroparesis

Contacts and locations

Locations

  • A+ Research Inc

    Miami, Florida, 33144, United States

  • A1 Clinical Network

    Richmond Hill, New York, 11418, United States

  • A1 Clinical Network

    Spring, Texas, 77386, United States

  • Aa Mrc, Llc

    Flint, Michigan, 48504, United States

  • Advanced Medical Research Group

    Hollywood, Florida, 33021, United States

  • Advanced Research Institute Inc

    New Port Richey, Florida, 34653, United States

  • Alliance Research Institute - Bell Gardens

    Bell Gardens, California, 90201, United States

  • Alliance Research Institute, LLC

    Canoga Park, California, 91304, United States

  • Alliance for Multispecialty Research - Wichita West

    Wichita, Kansas, 67205, United States

  • Allied Health Clinical Research Organization, LLC (AHCRO) - Englewood

    Englewood, New Jersey, 07631, United States

  • Allied Health Clinical Research Organization, LLC (AHCRO) - Freehold

    Freehold, New Jersey, 07728, United States

  • Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson

    Jackson, New Jersey, 08527, United States

  • American Institute of Medical Research

    Las Vegas, Nevada, 89123, United States

  • Amir A Hassan, MD, PA

    Houston, Texas, 77089, United States

  • Angel City Research

    Los Angeles, California, 90010, United States

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72212, United States

  • Arkansas Gastroenterology - North Little Rock

    North Little Rock, Arkansas, 72117, United States

  • Atlanta Center for Gastroenterology P.C.

    Decatur, Georgia, 30033, United States

  • Atrium Health - Center for Digestive Health

    Charlotte, North Carolina, 28204, United States

  • Aurora Care Clinic

    Costa Mesa, California, 92627, United States

  • Biopharma Informatic, LLC

    McAllen, Texas, 78503, United States

  • Care and Cure Clinic

    Houston, Texas, 77090, United States

  • Carolina's GI Research

    Raleigh, North Carolina, 27612, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • ClinCloud LLC

    Maitland, Florida, 32751, United States

  • Clinical Research Associates, LLC

    Huntsville, Alabama, 35801, United States

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047, United States

  • Clinical Research Institute of Michigan, LLC - Troy

    Troy, Michigan, 48098, United States

  • Coastal Research Institute, LLC

    Fayetteville, North Carolina, 28304, United States

  • Cross Creek Medical, PA

    Fayetteville, North Carolina, 28304, United States

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715, United States

  • DelRicht Clinical Research - Cincinnati

    Mason, Ohio, 45040, United States

  • DelRicht Clinical Research - Louisville

    Louisville, Kentucky, 40205, United States

  • DelRicht Clinical Research - McKinney

    McKinney, Texas, 75070, United States

  • DelRicht Clinical Research - Nashville

    Henderson, Tennessee, 37075, United States

  • DelRicht Clinical Research - Overland Park

    Overland Park, Kansas, 66209, United States

  • Delta Research Partners

    Bastrop, Louisiana, 71201, United States

  • Digestive Disease Specialists

    Las Vegas, Nevada, 89128, United States

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305, United States

  • Epic Clinical Research

    Lewisville, Texas, 75057, United States

  • Erick H. Alayo Medical Corporation

    Chula Vista, California, 91910, United States

  • Facey Medical Research

    Mission Hills, California, 11333, United States

  • G & L Research, LLC

    Foley, Alabama, 36535, United States

  • GW Research Inc.

    Chula Vista, California, 91910, United States

  • Galen Medical Group - Downtown Gastroenterology Location

    Chattanooga, Tennessee, 37343, United States

  • Gastroenterology Associates of Western Michigan

    Wyoming, Michigan, 49519, United States

  • Gastroenterology Research of San Antonio

    San Antonio, Texas, 78229, United States

  • Gastroenterology of Greater Orlando

    Orange City, Florida, 32763, United States

  • HP Clinical Research (Val R. Hansen)

    Bountiful, Utah, 84010, United States

  • Hope Clinical Research LLC

    Canoga Park, California, 91303, United States

  • Houston Methodist Research Institute

    Houston, Texas, 77030, United States

  • Innovative Research of West Florida

    Clearwater, Florida, 33756, United States

  • International Research Associates LLC - Breton

    Miami, Florida, 33183, United States

  • Kansas City Research Institute

    Kansas City, Missouri, 64131, United States

  • Kansas Medical Clinic, P.A.

    Topeka, Kansas, 66606, United States

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879, United States

  • Lutheran Medical Group

    Fort Wayne, Indiana, 46804, United States

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • Medisphere Medical Research Center

    Evansville, Indiana, 47714, United States

  • Millennium Clinical Trials

    Thousand Oaks, California, 91360, United States

  • Montana Medical Research, Inc.

    Missoula, Montana, 59808, United States

  • NY Scientific

    Brooklyn, New York, 11235, United States

  • Nature Coast Clinical Research

    Inverness, Florida, 34452, United States

  • New Hope Research Development

    Corona, California, 92882, United States

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

    Arlington, Texas, 76012, United States

  • Northshore Gastroenterology Research, LLC

    Westlake, Ohio, 44145, United States

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina, 28144, United States

  • Onyx Clinical Research

    Phoenix, Arizona, 85381, United States

  • Options Health Research

    Tulsa, Oklahoma, 74104, United States

  • Paragon Rx Clinical

    Garden Grove, California, 92840, United States

  • Peters Medical Research

    High Point, North Carolina, 27260, United States

  • Phoenix Medical Research Institute, LLC

    Peoria, Arizona, 85381, United States

  • Pioneer Research Solutions Inc.

    Houston, Texas, 77099, United States

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211, United States

  • Remington Davis, Inc.

    Columbus, Ohio, 43215, United States

  • Research Carolina Elite, LLC

    Denver, North Carolina, 28037, United States

  • Smart Medical Research

    Brooklyn, New York, 11372, United States

  • St. Charles Clinical Research

    Weldon Spring, Missouri, 63304, United States

  • Summit Clinical Research, LLC

    Athens, Georgia, 30607, United States

  • Susquehanna Research Group, LLC

    Harrisburg, Pennsylvania, 17110, United States

  • Tandem Clinical Research

    Marrero, Louisiana, 70072, United States

  • Tandem Clinical Research - Viera

    Viera, Florida, 32940, United States

  • Tandem Clinical Research GI - Houma

    Houma, Louisiana, 70363, United States

  • Tandem Clinical Research GI - Metairie

    Metairie, Louisiana, 70006, United States

  • Tandem Clinical Research GI- New York

    New York, New York, 10033, United States

  • Texas Gastro Research, LLC

    El Paso, Texas, 10908, United States

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79905, United States

  • Torrance Clinical Research Institute Inc.

    Lomita, California, 09717, United States

  • Triad Clinical Trials LLC

    Greensboro, North Carolina, 27410, United States

  • USA and International Research Inc.

    Doral, Florida, 33126, United States

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66160, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • Valley View Wellness and Medical Center - VVCRD

    Garden Grove, California, 92845, United States

  • Velocity Clinical Research

    Medford, Oregon, 97504, United States

  • Velocity Clinical Research - Salt Lake City

    West Jordan, Utah, 84065, United States

  • Velocity Clinical Research - Syracuse

    East Syracuse, New York, 13057, United States

  • WR ClinSearch

    Chattanooga, Tennessee, 37421, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215, United States

  • Zenos Clinical Research

    Dallas, Texas, 75230, United States

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