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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetic Gastroparesis
• Intervention / Treatment: Drug: Placebo; Drug: CIN-102 Dose 15mg or 10mg

• Study Type: Interventional
• Enrollment (Actual): 382
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Digestive Health Specialists Of The Southeast
    • Foley, Alabama, United States, 36535
      • G & L Research, LLC
    • Huntsville, Alabama, United States, 35801
      • Clinical Research Associates, LLC
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Phoenix Medical Research Institute, LLC
    • Phoenix, Arizona, United States, 85381
      • Onyx Clinical Research
    • 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, 72212
      • Applied Research Center of Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Gastroenterology - North Little Rock
  • California
    • Bell Gardens, California, United States, 90201
      • Alliance Research Institute - Bell Gardens
    • Canoga Park, California, United States, 91303
      • Hope clinical Research LLC
    • Canoga Park, California, United States, 91304
      • Alliance Research Institute, LLC
    • Chula Vista, California, United States, 91910
      • GW Research Inc.
    • Chula Vista, California, United States, 91910
      • Erick H. Alayo Medical Corporation
    • Corona, California, United States, 92879
      • Kindred Medical Institute for Clinical Trials, LLC
    • Corona, California, United States, 92882
      • New Hope Research Development
    • Costa Mesa, California, United States, 92627
      • Aurora Care Clinic
    • Garden Grove, California, United States, 92840
      • Paragon RX Clinical
    • Garden Grove, California, United States, 92845
      • Valley View Wellness and Medical Center - VVCRD
    • Lomita, California, United States, 09717
      • Torrance Clinical Research Institute Inc.
    • Los Angeles, California, United States, 90010
      • Angel City Research
    • Mission Hills, California, United States, 11333
      • Facey Medical Research
    • Thousand Oaks, California, United States, 91360
      • Millennium Clinical Trials
  • Florida
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West Florida
    • 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
    • Maitland, Florida, United States, 32751
      • ClinCloud LLC
    • Miami, Florida, United States, 33144
      • A+ Research Inc
    • Miami, Florida, United States, 33183
      • International Research Associates LLC - Breton
    • New Port Richey, Florida, United States, 34653
      • Advanced Research Institute Inc
    • Orange City, Florida, United States, 32763
      • Gastroenterology of Greater Orlando
    • Viera, Florida, United States, 32940
      • Tandem Clinical Research - Viera
  • Georgia
    • Athens, Georgia, United States, 30607
      • Summit Clinical Research, LLC
    • Decatur, Georgia, United States, 30033
      • Atlanta Center For Gastroenterology P.C.
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Medisphere Medical Research Center
    • Fort Wayne, Indiana, United States, 46804
      • Lutheran Medical Group
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center (KUMC)
    • Overland Park, Kansas, United States, 66209
      • DelRicht Clinical Research - Overland Park
    • Topeka, Kansas, United States, 66606
      • Kansas Medical Clinic, P.A.
    • Wichita, Kansas, United States, 67205
      • Alliance for Multispecialty Research - Wichita West
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
    • Louisville, Kentucky, United States, 40205
      • DelRicht Clinical Research - Louisville
  • Louisiana
    • Bastrop, Louisiana, United States, 71201
      • Delta Research Partners
    • Houma, Louisiana, United States, 70363
      • Tandem Clinical Research GI - Houma
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
    • Metairie, Louisiana, United States, 70006
      • Tandem Clinical Research GI - Metairie
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
    • Flint, Michigan, United States, 48504
      • Aa Mrc, Llc
    • Troy, Michigan, United States, 48098
      • Clinical Research Institute of Michigan, LLC - Troy
    • Wyoming, Michigan, United States, 49519
      • Gastroenterology Associates of Western Michigan
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Kansas City Research Institute
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Weldon Spring, Missouri, United States, 63304
      • St. Charles Clinical Research
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research, Inc.
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Digestive Disease Specialists
    • Las Vegas, Nevada, United States, 89123
      • American Institute of Medical Research
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Allied Health Clinical Research Organization, LLC (AHCRO) - Englewood
    • Freehold, New Jersey, United States, 07728
      • Allied Health Clinical Research Organization, LLC (AHCRO) - Freehold
    • Jackson, New Jersey, United States, 08527
      • Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson
  • New York
    • Brooklyn, New York, United States, 11235
      • NY Scientific
    • Brooklyn, New York, United States, 11372
      • Smart Medical Research
    • East Syracuse, New York, United States, 13057
      • Velocity Clinical Research - Syracuse
    • New York, New York, United States, 10033
      • Tandem Clinical Research GI- New York
    • Richmond Hill, New York, United States, 11418
      • A1 Clinical Network
  • North Carolina
    • Charlotte, North Carolina, United States, 28144
      • Onsite Clinical Solutions, LLC
    • Charlotte, North Carolina, United States, 28204
      • Atrium Health - Center for Digestive Health
    • Denver, North Carolina, United States, 28037
      • Research Carolina Elite, LLC
    • Fayetteville, North Carolina, United States, 28304
      • Coastal Research Institute, LLC
    • Fayetteville, North Carolina, United States, 28304
      • Cross Creek Medical, PA
    • Greensboro, North Carolina, United States, 27410
      • Triad Clinical Trials LLC
    • High Point, North Carolina, United States, 27260
      • Peters Medical Research
    • Raleigh, North Carolina, United States, 27612
      • Carolina's GI Research
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43215
      • Remington Davis, Inc.
    • Mason, Ohio, United States, 45040
      • DelRicht Clinical Research - Cincinnati
    • Westlake, Ohio, United States, 44145
      • NorthShore Gastroenterology Research, LLC
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17110
      • Susquehanna Research Group, LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37343
      • Galen Medical Group - Downtown Gastroenterology Location
    • Chattanooga, Tennessee, United States, 37421
      • WR ClinSearch
    • Henderson, Tennessee, United States, 37075
      • DelRicht Clinical Research - Nashville
  • Texas
    • Arlington, Texas, United States, 76012
      • North Hills Medical Research Inc. (North Hills Familiy Medicine)
    • Dallas, Texas, United States, 75230
      • Zenos Clinical Research
    • El Paso, Texas, United States, 10908
      • Texas Gastro Research, LLC
    • Houston, Texas, United States, 77030
      • Houston Methodist Research Institute
    • Houston, Texas, United States, 77099
      • Pioneer Research Solutions Inc.
    • Houston, Texas, United States, 77089
      • Amir A Hassan, MD, PA
    • Houston, Texas, United States, 77090
      • Care and Cure Clinic
    • Lewisville, Texas, United States, 75057
      • Epic Clinical Research
    • Lubbock, Texas, United States, 79905
      • Texas Tech University Health Sciences Center
    • McAllen, Texas, United States, 78503
      • Biopharma Informatic, LLC
    • McKinney, Texas, United States, 75070
      • DelRicht Clinical Research - McKinney
    • San Antonio, Texas, United States, 78229
      • Gastroenterology Research of San Antonio
    • Spring, Texas, United States, 77386
      • A1 Clinical Network
  • Utah
    • Bountiful, Utah, United States, 84010
      • HP Clinical Research (Val R. Hansen)
    • West Jordan, Utah, United States, 84065
      • Velocity Clinical Research - Salt Lake City
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research

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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CIN-102: Dose 15mg or 10mg; CIN-102, Dose 15 mg or 10 mg, twice daily for 12 weeks	Drug: CIN-102 Dose 15mg or 10mg; 2 capsules twice daily for 12 weeks
Placebo Comparator: Placebo; Placebo for CIN-102, twice daily for 12 weeks	Drug: Placebo; 2 capsules twice daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of clinically significant changes, in the Investigator's opinion, in laboratory parameters, physical examination findings, 12-lead ECG parameters, weight measurement.		Over the 12-week Treatment Period
Incidence of treatment-emergent adverse events (TEAEs)		Over the 12-week Treatment Period
Incidence of treatment emergent Serious Adverse Events (SAEs)		Over the 12-week Treatment Period
Incidence of TEAEs leading to premature discontinuation of study drug		Over the 12-week Treatment Period
Incidence of treatment-emergent marked laboratory abnormalities.		Over the 12-week Treatment Period
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.		Over the last 6 weeks of the 12-week Treatment Period
Change in the PGIS with each dose of CIN-102		From baseline to Week 12
Change in the PGIC with each dose of CIN-102		From baseline to Week 12
Percentage of responders who demonstrate an average ≥0.5 reduction from baseline on the ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores		Over the last 2 weeks of the 12-week Treatment Period
Percentage of subjects achieving a ≥30% reduction from baseline on a composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores		Over the last 2 weeks of the 12-week Treatment Period
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	Symptomatic days defined as >mild (ANMS GCSI-DD scores >2)	Over the last 2 weeks of the 12-week Treatment Period
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;		Over the 12-week Treatment Period
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	Composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores	Over the last 2 weeks of the 12-week Treatment Period as compared to baseline
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 and Sub-Scale Scores	Over the last 2 weeks of the 12-week Treatment Period as compared to baseline
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)		Over the 12-week Treatment Period as compared to baseline
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		Over the last 2 weeks of the 12-week Treatment Period
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		Over the last 2 weeks of the 12-week Treatment Period
The change in the ANMS GSCI-DD Total Score and a composite of gastroparesis-related symptoms among subjects receiving GLP-1RA;		over the last 2 weeks of the 12-week Treatment Period, as compared to baseline

Collaborators and Investigators

• Sponsor: CinDome Pharma, Inc.

Publications and helpful links

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Actual): November 14, 2025
• Study Completion (Actual): December 12, 2025

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Nausea; Vomiting; Gastroparesis; Stomach; Gastrointestinal disease; Delayed gastric emptying; Diabetic gastroparesis; Digestive system diseases; Dopamine receptor antagonist
• Additional Relevant MeSH Terms: Neurologic Manifestations; Signs and Symptoms, Digestive; Stomach Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Nausea; Vomiting; Gastroparesis
• Other Study ID Numbers: CIN-102-123

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