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Diabetic GastroparesisPhase 2NCT05832151

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

A Phase 2 study testing CIN-102 Dose 15mg or 10mg in people with Diabetic Gastroparesis, run by CinDome Pharma, Inc. at 100 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Gastroparesis
What is being tested?
CIN-102 Dose 15mg or 10mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
382 participants
Where
100 sitesUnited States
Study dates
27 Mar 2023to 12 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Persistent gastrointestinal symptoms that in the opinion of the Investigator are consistent with gastroparesis within 6 months prior to Screening; AND
  • 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;
Show all 14Show fewer
  • 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:
  • The GLP-1 RA has been prescribed for the management of diabetes and not specifically for weight loss/weight management;
  • 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;
  • Is tolerating the GLP-1RA well based on Investigator's judgment;
  • None of the study-qualifying signs/symptoms of gastroparesis are solely attributable to the use of GLP-1RA; and
  • The symptoms of gastroparesis preceded the initiation of GLP-1RA therapy.
  • Willing to washout from ongoing treatment for gastroparesis.

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

100 sites in 1 country.

100 sites in 1 country

United States100 sites

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

    Arlington, Texas, 76012

  • Summit Clinical Research, LLC

    Athens, Georgia, 30607

  • Delta Research Partners

    Bastrop, Louisiana, 71201

  • Alliance Research Institute - Bell Gardens

    Bell Gardens, California, 90201

  • HP Clinical Research (Val R. Hansen)

    Bountiful, Utah, 84010

  • NY Scientific

    Brooklyn, New York, 11235

  • Smart Medical Research

    Brooklyn, New York, 11372

  • Hope Clinical Research LLC

    Canoga Park, California, 91303

  • Alliance Research Institute, LLC

    Canoga Park, California, 91304

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina, 28144

  • Atrium Health - Center for Digestive Health

    Charlotte, North Carolina, 28204

  • Galen Medical Group - Downtown Gastroenterology Location

    Chattanooga, Tennessee, 37343

  • WR ClinSearch

    Chattanooga, Tennessee, 37421

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Erick H. Alayo Medical Corporation

    Chula Vista, California, 91910

  • GW Research Inc.

    Chula Vista, California, 91910

  • Innovative Research of West Florida

    Clearwater, Florida, 33756

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Remington Davis, Inc.

    Columbus, Ohio, 43215

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879

  • New Hope Research Development

    Corona, California, 92882

  • Aurora Care Clinic

    Costa Mesa, California, 92627

  • Zenos Clinical Research

    Dallas, Texas, 75230

  • Atlanta Center for Gastroenterology P.C.

    Decatur, Georgia, 30033

  • Research Carolina Elite, LLC

    Denver, North Carolina, 28037

  • USA and International Research Inc.

    Doral, Florida, 33126

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • Velocity Clinical Research - Syracuse

    East Syracuse, New York, 13057

  • Texas Gastro Research, LLC

    El Paso, Texas, 10908

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

    Englewood, New Jersey, 07631

  • Medisphere Medical Research Center

    Evansville, Indiana, 47714

  • Coastal Research Institute, LLC

    Fayetteville, North Carolina, 28304

  • Cross Creek Medical, PA

    Fayetteville, North Carolina, 28304

  • Aa Mrc, Llc

    Flint, Michigan, 48504

  • G & L Research, LLC

    Foley, Alabama, 36535

  • Lutheran Medical Group

    Fort Wayne, Indiana, 46804

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

    Freehold, New Jersey, 07728

  • Paragon Rx Clinical

    Garden Grove, California, 92840

  • Valley View Wellness and Medical Center - VVCRD

    Garden Grove, California, 92845

  • Triad Clinical Trials LLC

    Greensboro, North Carolina, 27410

  • Susquehanna Research Group, LLC

    Harrisburg, Pennsylvania, 17110

  • DelRicht Clinical Research - Nashville

    Henderson, Tennessee, 37075

  • Peters Medical Research

    High Point, North Carolina, 27260

  • Advanced Medical Research Group

    Hollywood, Florida, 33021

  • Tandem Clinical Research GI - Houma

    Houma, Louisiana, 70363

  • Houston Methodist Research Institute

    Houston, Texas, 77030

  • Amir A Hassan, MD, PA

    Houston, Texas, 77089

  • Care and Cure Clinic

    Houston, Texas, 77090

  • Pioneer Research Solutions Inc.

    Houston, Texas, 77099

  • Clinical Research Associates, LLC

    Huntsville, Alabama, 35801

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

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

    Jackson, New Jersey, 08527

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66160

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • American Institute of Medical Research

    Las Vegas, Nevada, 89123

  • Digestive Disease Specialists

    Las Vegas, Nevada, 89128

  • Epic Clinical Research

    Lewisville, Texas, 75057

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72212

  • Torrance Clinical Research Institute Inc.

    Lomita, California, 09717

  • Angel City Research

    Los Angeles, California, 90010

  • University of Louisville

    Louisville, Kentucky, 40202

  • DelRicht Clinical Research - Louisville

    Louisville, Kentucky, 40205

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79905

  • ClinCloud LLC

    Maitland, Florida, 32751

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • DelRicht Clinical Research - Cincinnati

    Mason, Ohio, 45040

  • Biopharma Informatic, LLC

    McAllen, Texas, 78503

  • DelRicht Clinical Research - McKinney

    McKinney, Texas, 75070

  • Velocity Clinical Research

    Medford, Oregon, 97504

  • Tandem Clinical Research GI - Metairie

    Metairie, Louisiana, 70006

  • A+ Research Inc

    Miami, Florida, 33144

  • International Research Associates LLC - Breton

    Miami, Florida, 33183

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215

  • Facey Medical Research

    Mission Hills, California, 11333

  • Montana Medical Research, Inc.

    Missoula, Montana, 59808

  • Advanced Research Institute Inc

    New Port Richey, Florida, 34653

  • Tandem Clinical Research GI- New York

    New York, New York, 10033

  • Arkansas Gastroenterology - North Little Rock

    North Little Rock, Arkansas, 72117

  • Gastroenterology of Greater Orlando

    Orange City, Florida, 32763

  • DelRicht Clinical Research - Overland Park

    Overland Park, Kansas, 66209

  • Phoenix Medical Research Institute, LLC

    Peoria, Arizona, 85381

  • Onyx Clinical Research

    Phoenix, Arizona, 85381

  • Carolina's GI Research

    Raleigh, North Carolina, 27612

  • A1 Clinical Network

    Richmond Hill, New York, 11418

  • Gastroenterology Research of San Antonio

    San Antonio, Texas, 78229

  • A1 Clinical Network

    Spring, Texas, 77386

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Millennium Clinical Trials

    Thousand Oaks, California, 91360

  • Kansas Medical Clinic, P.A.

    Topeka, Kansas, 66606

  • Clinical Research Institute of Michigan, LLC - Troy

    Troy, Michigan, 48098

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715

  • Options Health Research

    Tulsa, Oklahoma, 74104

  • Tandem Clinical Research - Viera

    Viera, Florida, 32940

  • St. Charles Clinical Research

    Weldon Spring, Missouri, 63304

  • Velocity Clinical Research - Salt Lake City

    West Jordan, Utah, 84065

  • Northshore Gastroenterology Research, LLC

    Westlake, Ohio, 44145

  • Alliance for Multispecialty Research - Wichita West

    Wichita, Kansas, 67205

  • Gastroenterology Associates of Western Michigan

    Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: 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:

Read more
  • 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
Being tested
CIN-102 Dose 15mg or 10mg, Placebo
Keywords
Gastroparesis, Diabetic gastroparesis, Gastrointestinal disease, Delayed gastric emptying, Digestive system diseases, Nausea, Vomiting, Stomach, Dopamine receptor antagonist
Medical subject headings
Gastroparesis, Gastrointestinal Diseases, Digestive System Diseases, Nausea, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CIN-102 Dose 15mg or 10mgDrug

    2 capsules twice daily for 12 weeks

  • PlaceboDrug

    2 capsules twice daily for 12 weeks

Study groups in NCT05832151
Study groupRoleWhat they receive
CIN-102: Dose 15mg or 10mgExperimentalCIN-102, Dose 15 mg or 10 mg, twice daily for 12 weeks
Receives: Drug: CIN-102 Dose 15mg or 10mg
PlaceboPlacebo comparatorPlacebo for CIN-102, twice daily for 12 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Over the last 2 weeks of the 12-week Treatment Period as compared to baseline

Secondary outcomes (18)

  1. Incidence of clinically significant changes, in the Investigator's opinion, in laboratory parameters, physical examination findings, 12-lead ECG parameters, weight measurement.

    Measured: Over the 12-week Treatment Period

  2. Incidence of treatment-emergent adverse events (TEAEs)

    Measured: Over the 12-week Treatment Period

  3. Incidence of treatment emergent Serious Adverse Events (SAEs)

    Measured: Over the 12-week Treatment Period

  4. Incidence of TEAEs leading to premature discontinuation of study drug

    Measured: Over the 12-week Treatment Period

  5. Incidence of treatment-emergent marked laboratory abnormalities.

    Measured: Over the 12-week Treatment Period

  6. Percentage of responders who demonstrate an average ≥0.5 reduction from baseline on the ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores

    Measured: Over the last 2 weeks of the 12-week Treatment Period

  7. Percentage of subjects achieving a ≥30% reduction from baseline on a composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores

    Measured: Over the last 2 weeks of the 12-week Treatment Period

  8. 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)

    Measured: Over the last 2 weeks of the 12-week Treatment Period

  9. 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;

    Measured: Over the 12-week Treatment Period

  10. 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

    Measured: Over the last 2 weeks of the 12-week Treatment Period as compared to baseline

  11. 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

    Measured: Over the last 2 weeks of the 12-week Treatment Period as compared to baseline

  12. 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)

    Measured: Over the 12-week Treatment Period as compared to baseline

  13. 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

    Measured: Over the last 2 weeks of the 12-week Treatment Period

  14. 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

    Measured: Over the last 2 weeks of the 12-week Treatment Period

  15. The change in the ANMS GSCI-DD Total Score and a composite of gastroparesis-related symptoms among subjects receiving GLP-1RA;

    Measured: over the last 2 weeks of the 12-week Treatment Period, as compared to baseline

  16. 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.

    Measured: Over the last 6 weeks of the 12-week Treatment Period

  17. Change in the PGIS with each dose of CIN-102

    Measured: From baseline to Week 12

  18. Change in the PGIC with each dose of CIN-102

    Measured: From baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2023
  2. Study start27 Mar 2023
  3. Primary completion14 Nov 2025
  4. Study completion12 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
382 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05832151
Sponsor's protocol ID
CIN-102-123
Status last verified
Nov 2026
First submitted
16 Mar 2023
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CIN-102 Dose 15mg or 10mg in people with Diabetic Gastroparesis, run by CinDome Pharma, Inc. at 100 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Over the last 2 weeks of the 12-week Treatment Period as compared to baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05832151.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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