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

NCT05832151 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: CIN-102-123
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 100

Brief 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

Conditions

Diabetic Gastroparesis

Keywords

Gastroparesis; Diabetic gastroparesis; Gastrointestinal disease; Delayed gastric emptying; Digestive system diseases; Nausea; Vomiting; Stomach; Dopamine receptor antagonist

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (18)

• 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

Study Arms (2)

CIN-102: Dose 15mg or 10mg

EXPERIMENTAL

CIN-102, Dose 15 mg or 10 mg, twice daily for 12 weeks

Drug: CIN-102 Dose 15mg or 10mg

Placebo

PLACEBO COMPARATOR

Placebo for CIN-102, twice daily for 12 weeks

Drug: Placebo

Interventions

Placebo DRUG

2 capsules twice daily for 12 weeks

Placebo

CIN-102 Dose 15mg or 10mg DRUG

2 capsules twice daily for 12 weeks

CIN-102: Dose 15mg or 10mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CinDome Pharma, Inc.: lead

Study Sites (100)

Digestive Health Specialists of the Southeast

Dothan, Alabama, 36305, United States

Location

G & L Research, LLC

Foley, Alabama, 36535, United States

Location

Clinical Research Associates, LLC

Huntsville, Alabama, 35801, United States

Location

Phoenix Medical Research Institute, LLC

Peoria, Arizona, 85381, United States

Location

Onyx Clinical Research

Phoenix, Arizona, 85381, United States

Location

Del Sol Research Management, LLC

Tucson, Arizona, 85715, United States

Location

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

Arkansas Gastroenterology - North Little Rock

North Little Rock, Arkansas, 72117, United States

Location

Alliance Research Institute - Bell Gardens

Bell Gardens, California, 90201, United States

Location

Hope Clinical Research LLC

Canoga Park, California, 91303, United States

Location

Alliance Research Institute, LLC

Canoga Park, California, 91304, United States

Location

Erick H. Alayo Medical Corporation

Chula Vista, California, 91910, United States

Location

GW Research Inc.

Chula Vista, California, 91910, United States

Location

Kindred Medical Institute for Clinical Trials, LLC

Corona, California, 92879, United States

Location

New Hope Research Development

Corona, California, 92882, United States

Location

Aurora Care Clinic

Costa Mesa, California, 92627, United States

Location

Paragon Rx Clinical

Garden Grove, California, 92840, United States

Location

Valley View Wellness and Medical Center - VVCRD

Garden Grove, California, 92845, United States

Location

Torrance Clinical Research Institute Inc.

Lomita, California, 09717, United States

Location

Angel City Research

Los Angeles, California, 90010, United States

Location

Facey Medical Research

Mission Hills, California, 11333, United States

Location

Millennium Clinical Trials

Thousand Oaks, California, 91360, United States

Location

Innovative Research of West Florida

Clearwater, Florida, 33756, United States

Location

USA and International Research Inc.

Doral, Florida, 33126, United States

Location

Advanced Medical Research Group

Hollywood, Florida, 33021, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

ClinCloud LLC

Maitland, Florida, 32751, United States

Location

A+ Research Inc

Miami, Florida, 33144, United States

Location

International Research Associates LLC - Breton

Miami, Florida, 33183, United States

Location

Advanced Research Institute Inc

New Port Richey, Florida, 34653, United States

Location

Gastroenterology of Greater Orlando

Orange City, Florida, 32763, United States

Location

Tandem Clinical Research - Viera

Viera, Florida, 32940, United States

Location

Summit Clinical Research, LLC

Athens, Georgia, 30607, United States

Location

Atlanta Center for Gastroenterology P.C.

Decatur, Georgia, 30033, United States

Location

Medisphere Medical Research Center

Evansville, Indiana, 47714, United States

Location

Lutheran Medical Group

Fort Wayne, Indiana, 46804, United States

Location

University of Kansas Medical Center (KUMC)

Kansas City, Kansas, 66160, United States

Location

DelRicht Clinical Research - Overland Park

Overland Park, Kansas, 66209, United States

Location

Kansas Medical Clinic, P.A.

Topeka, Kansas, 66606, United States

Location

Alliance for Multispecialty Research - Wichita West

Wichita, Kansas, 67205, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

DelRicht Clinical Research - Louisville

Louisville, Kentucky, 40205, United States

Location

Delta Research Partners

Bastrop, Louisiana, 71201, United States

Location

Tandem Clinical Research GI - Houma

Houma, Louisiana, 70363, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Tandem Clinical Research GI - Metairie

Metairie, Louisiana, 70006, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Aa Mrc, Llc

Flint, Michigan, 48504, United States

Location

Clinical Research Institute of Michigan, LLC - Troy

Troy, Michigan, 48098, United States

Location

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, 49519, United States

Location

Kansas City Research Institute

Kansas City, Missouri, 64131, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

St. Charles Clinical Research

Weldon Spring, Missouri, 63304, United States

Location

Montana Medical Research, Inc.

Missoula, Montana, 59808, United States

Location

American Institute of Medical Research

Las Vegas, Nevada, 89123, United States

Location

Digestive Disease Specialists

Las Vegas, Nevada, 89128, United States

Location

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

Englewood, New Jersey, 07631, United States

Location

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

Freehold, New Jersey, 07728, United States

Location

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

Jackson, New Jersey, 08527, United States

Location

NY Scientific

Brooklyn, New York, 11235, United States

Location

Smart Medical Research

Brooklyn, New York, 11372, United States

Location

Velocity Clinical Research - Syracuse

East Syracuse, New York, 13057, United States

Location

Tandem Clinical Research GI- New York

New York, New York, 10033, United States

Location

A1 Clinical Network

Richmond Hill, New York, 11418, United States

Location

OnSite Clinical Solutions, LLC

Charlotte, North Carolina, 28144, United States

Location

Atrium Health - Center for Digestive Health

Charlotte, North Carolina, 28204, United States

Location

Research Carolina Elite, LLC

Denver, North Carolina, 28037, United States

Location

Coastal Research Institute, LLC

Fayetteville, North Carolina, 28304, United States

Location

Cross Creek Medical, PA

Fayetteville, North Carolina, 28304, United States

Location

Triad Clinical Trials LLC

Greensboro, North Carolina, 27410, United States

Location

Peters Medical Research

High Point, North Carolina, 27260, United States

Location

Carolina's GI Research

Raleigh, North Carolina, 27612, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Remington Davis, Inc.

Columbus, Ohio, 43215, United States

Location

DelRicht Clinical Research - Cincinnati

Mason, Ohio, 45040, United States

Location

Northshore Gastroenterology Research, LLC

Westlake, Ohio, 44145, United States

Location

Options Health Research

Tulsa, Oklahoma, 74104, United States

Location

Velocity Clinical Research

Medford, Oregon, 97504, United States

Location

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, 17110, United States

Location

Galen Medical Group - Downtown Gastroenterology Location

Chattanooga, Tennessee, 37343, United States

Location

WR ClinSearch

Chattanooga, Tennessee, 37421, United States

Location

DelRicht Clinical Research - Nashville

Henderson, Tennessee, 37075, United States

Location

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

Arlington, Texas, 76012, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

Texas Gastro Research, LLC

El Paso, Texas, 10908, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

Amir A Hassan, MD, PA

Houston, Texas, 77089, United States

Location

Care and Cure Clinic

Houston, Texas, 77090, United States

Location

Pioneer Research Solutions Inc.

Houston, Texas, 77099, United States

Location

Epic Clinical Research

Lewisville, Texas, 75057, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79905, United States

Location

Biopharma Informatic, LLC

McAllen, Texas, 78503, United States

Location

DelRicht Clinical Research - McKinney

McKinney, Texas, 75070, United States

Location

Gastroenterology Research of San Antonio

San Antonio, Texas, 78229, United States

Location

A1 Clinical Network

Spring, Texas, 77386, United States

Location

HP Clinical Research (Val R. Hansen)

Bountiful, Utah, 84010, United States

Location

Velocity Clinical Research - Salt Lake City

West Jordan, Utah, 84065, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, 53215, United States

Location

Related Links

• Study website

MeSH Terms

Conditions

Gastroparesis; Gastrointestinal Diseases; Digestive System Diseases; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Stomach Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 27, 2023
• Study Start: March 27, 2023
• Primary Completion: November 14, 2025
• Study Completion: December 12, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (100)