A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis

Last updated: February 27, 2025
Sponsor: CinDome Pharma, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetic Gastroparesis

Gastroparesis

Treatment

CIN-102 Dose 1

CIN-102 Dose 1 or 2

Placebo

Clinical Study ID

NCT05832151
CIN-102-123
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 DiabetesAssociation criteria;

  • Has a current diagnosis of diabetic gastroparesis defined by the following:

  1. Persistent gastrointestinal symptoms that in the opinion of the Investigatorare consistent with gastroparesis within 6 months prior to Screening; AND

  2. Documented delayed gastric emptying as determined by gastric emptying breathtest (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 thefollowing criteria are satisfied:

  1. The GLP-1 RA has been prescribed for the management of diabetes and notspecifically for weight loss/weight management;

  2. Has been on a stable dose of GLP-1RA for a minimum of 3 months before Screeningand is anticipated to sustain the same dose during GEBT and throughout thestudy;

  3. Is tolerating the GLP-1RA well based on Investigator's judgment;

  4. None of the study-qualifying signs/symptoms of gastroparesis are solelyattributable 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.

Exclusion

Key Exclusion Criteria:

  • Has known cause of gastroparesis other than diabetes (eg, idiopathic gastroparesisand/or gastroparesis attributed to surgery, viral illness, cancer, scleroderma, orother neurologic disorder);

  • Has been hospitalized within 3 months prior to Visit 1 for diabetic gastroparesisand/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 enteraltube 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 orbreastfeed during the study.

Study Design

Total Participants: 288
Treatment Group(s): 5
Primary Treatment: CIN-102 Dose 1
Phase: 2
Study Start date:
March 27, 2023
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama 36305
    United States

    Completed

  • G & L Research, LLC

    Foley, Alabama 36535
    United States

    Active - Recruiting

  • Clinical Research Associates, LLC

    Huntsville, Alabama 35801
    United States

    Active - Recruiting

  • Phoenix Medical Research Institute, LLC

    Peoria, Arizona 85381
    United States

    Completed

  • Onyx Clinical Research

    Phoenix, Arizona 85381
    United States

    Active - Recruiting

  • Voyage Medical

    Tempe, Arizona 85282
    United States

    Site Not Available

  • Adobe Clinical Research, LLC

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • Del Sol Research Management, LLC

    Tucson, Arizona 85715
    United States

    Active - Recruiting

  • Applied Research Center of Arkansas

    Little Rock, Arkansas 72212
    United States

    Active - Recruiting

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas 72211
    United States

    Completed

  • Arkansas Gastroenterology - North Little Rock

    North Little Rock, Arkansas 72117
    United States

    Completed

  • Alliance Research Institute - Bell Gardens

    Bell Gardens, California 90201
    United States

    Active - Recruiting

  • Alliance Research Institute, LLC

    Canoga Park, California 91304
    United States

    Active - Recruiting

  • Hope Clinical Research LLC

    Canoga Park, California 91303
    United States

    Active - Recruiting

  • Erick H. Alayo Medical Corporation

    Chula Vista, California 91910
    United States

    Active - Recruiting

  • GW Research Inc.

    Chula Vista, California 91910
    United States

    Completed

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California 92879
    United States

    Active - Recruiting

  • New Hope Research Development

    Corona, California 92882
    United States

    Active - Recruiting

  • Aurora Care Clinic

    Costa Mesa, California 92627
    United States

    Active - Recruiting

  • Paragon Rx Clinical

    Garden Grove, California 92840
    United States

    Active - Recruiting

  • Valley View Wellness and Medical Center - VVCRD

    Garden Grove, California 92845
    United States

    Active - Recruiting

  • Torrance Clinical Research Institute Inc.

    Lomita, California 09717
    United States

    Active - Recruiting

  • Angel City Research

    Los Angeles, California 90010
    United States

    Active - Recruiting

  • Facey Medical Research

    Mission Hills, California 11333
    United States

    Completed

  • Precision Research Institute, LLC

    San Diego, California 92114
    United States

    Site Not Available

  • Millennium Clinical Trials

    Thousand Oaks, California 91360
    United States

    Active - Recruiting

  • Innovative Research of West Florida

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • USA and International Research Inc.

    Doral, Florida 33126
    United States

    Active - Recruiting

  • Advanced Medical Research Group

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Nature Coast Clinical Research

    Inverness, Florida 34452
    United States

    Active - Recruiting

  • ClinCloud LLC

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • A+ Research Inc

    Miami, Florida 33144
    United States

    Active - Recruiting

  • International Research Associates LLC - Breton

    Miami, Florida 33183
    United States

    Active - Recruiting

  • Advanced Research Institute Inc

    New Port Richey, Florida 34653
    United States

    Active - Recruiting

  • Gastroenterology of Greater Orlando

    Orange City, Florida 32763
    United States

    Completed

  • Tandem Clinical Research - Viera

    Viera, Florida 32940
    United States

    Active - Recruiting

  • Summit Clinical Research, LLC

    Athens, Georgia 30607
    United States

    Completed

  • Atlanta Center for Gastroenterology P.C.

    Decatur, Georgia 30033
    United States

    Completed

  • Medisphere Medical Research Center

    Evansville, Indiana 47714
    United States

    Completed

  • Lutheran Medical Group

    Fort Wayne, Indiana 46804
    United States

    Completed

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Kansas Medical Clinic, P.A.

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research - Wichita West

    Wichita, Kansas 67205
    United States

    Completed

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Completed

  • Delta Research Partners

    Bastrop, Louisiana 71201
    United States

    Active - Recruiting

  • Tandem Clinical Research GI - Houma

    Houma, Louisiana 70363
    United States

    Completed

  • Tandem Clinical Research

    Marrero, Louisiana 70072
    United States

    Completed

  • Tandem Clinical Research GI - Metairie

    Metairie, Louisiana 70006
    United States

    Active - Recruiting

  • Delta Research Partners

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • Voyage Medical Services, PLLC- Canton, Mighica

    Canton, Michigan 85282
    United States

    Site Not Available

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan 48047
    United States

    Active - Recruiting

  • Aa Mrc, Llc

    Flint, Michigan 48504
    United States

    Active - Recruiting

  • Clinical Research Institute of Michigan, LLC - Troy

    Troy, Michigan 48098
    United States

    Completed

  • Gastroenterology Associates of Western Michigan

    Wyoming, Michigan 49519
    United States

    Active - Recruiting

  • Kansas City Research Institute

    Kansas City, Missouri 64131
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Completed

  • St. Charles Clinical Research

    Weldon Spring, Missouri 63304
    United States

    Active - Recruiting

  • Montana Medical Research, Inc.

    Missoula, Montana 59808
    United States

    Completed

  • American Institute of Medical Research

    Las Vegas, Nevada 89123
    United States

    Active - Recruiting

  • Digestive Disease Specialists

    Las Vegas, Nevada 89128
    United States

    Completed

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

    Englewood, New Jersey 07631
    United States

    Completed

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

    Freehold, New Jersey 07728
    United States

    Completed

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

    Jackson, New Jersey 08527
    United States

    Completed

  • NY Scientific

    Brooklyn, New York 11235
    United States

    Active - Recruiting

  • Smart Medical Research

    Brooklyn, New York 11372
    United States

    Completed

  • Velocity Clinical Research - Syracuse

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • Long Island Gastrointestinal Research Group

    Great Neck, New York 11023
    United States

    Site Not Available

  • Smart Medical Research

    Jackson Heights, New York 11372
    United States

    Site Not Available

  • Tandem Clinical Research GI- New York

    New York, New York 10033
    United States

    Active - Recruiting

  • A1 Clinical Network

    Richmond Hill, New York 11418
    United States

    Completed

  • Atrium Health - Center for Digestive Health

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina 28144
    United States

    Completed

  • Research Carolina Elite, LLC

    Denver, North Carolina 28037
    United States

    Completed

  • Coastal Research Institute, LLC

    Fayetteville, North Carolina 28304
    United States

    Active - Recruiting

  • Triad Clinical Trials LLC

    Greensboro, North Carolina 27410
    United States

    Completed

  • Peters Medical Research

    High Point, North Carolina 27260
    United States

    Active - Recruiting

  • Carolina's GI Research

    Raleigh, North Carolina 27612
    United States

    Completed

  • OnSite Clinical Solutions, LLC

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Completed

  • Remington Davis, Inc.

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • Northshore Gastroenterology Research, LLC

    Westlake, Ohio 44145
    United States

    Active - Recruiting

  • Options Health Research

    Tulsa, Oklahoma 74104
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Medford, Oregon 97504
    United States

    Completed

  • Susquehanna Research Group, LLC

    Harrisburg, Pennsylvania 17110
    United States

    Active - Recruiting

  • Galen Medical Group - Downtown Gastroenterology Location

    Chattanooga, Tennessee 37343
    United States

    Active - Recruiting

  • WR ClinSearch

    Chattanooga, Tennessee 37421
    United States

    Completed

  • Galen Medical Group - Downtown Gastroenterology Location

    Hixson, Tennessee 37343
    United States

    Site Not Available

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

    Arlington, Texas 76012
    United States

    Active - Recruiting

  • Zenos Clinical Research

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Texas Gastro Research, LLC

    El Paso, Texas 10908
    United States

    Completed

  • Texas Tech University Health Sciences Center

    El Paso, Texas 79905
    United States

    Active - Recruiting

  • Amir A Hassan, MD, PA

    Houston, Texas 77089
    United States

    Active - Recruiting

  • Care and Cure Clinic

    Houston, Texas 77090
    United States

    Completed

  • Houston Methodist Research Institute

    Houston, Texas 77030
    United States

    Completed

  • Pioneer Research Solutions Inc.

    Houston, Texas 77099
    United States

    Active - Recruiting

  • Texas Tech University Health Sciences Center

    Lubbock, Texas 79905
    United States

    Active - Recruiting

  • Biopharma Informatic, LLC

    McAllen, Texas 78503
    United States

    Completed

  • Gastroenterology Research of San Antonio

    San Antonio, Texas 78229
    United States

    Completed

  • A1 Clinical Network

    Spring, Texas 77386
    United States

    Completed

  • HP Clinical Research (Val R. Hansen)

    Bountiful, Utah 84010
    United States

    Completed

  • Velocity Clinical Research - Salt Lake City

    Riverton, Utah 84065
    United States

    Site Not Available

  • Velocity Clinical Research - Salt Lake City

    West Jordan, Utah 84065
    United States

    Completed

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Active - Recruiting

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin 53215
    United States

    Completed

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