A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.

NCT06899217 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CIN-102-124
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 85

Brief Summary

The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help to decrease nausea severity associated with idiopathic gastroparesis severity in adult subjects. The main questions it aims to answer are:

• To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with idiopathic gastroparesis compared to a placebo
• To evaluate the safety of CIN-102 when given to patients with idiopathic gastroparesis compared to a placebo Participants will go through the following schedule:
• Pre-screening (1 visit)
• Screening \& Lead-In (1-2 visits)
• 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.
• Lead-In Period (1 visit)
• 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:
• 15 mg CIN-102, taken orally BID for 12 weeks
• 10 mg CIN-102, taken orally BID for 12 weeks
• Placebo for CIN-102, taken orally BID for 12 weeks

Conditions

Idiopathic Gastroparesis

Keywords

Gastroparesis; Idiopathic Gastroparesis; Vomiting; Early satiety; Bloating; Epigastric pain; Abdominal pain; Delayed gastric emptying; Dopamine receptor antagonist; Nausea; Post-prandial fullness; Stomach pain; Gastric statis; Dysmotility; Gastric motility

Outcome Measures

Primary Outcomes (1)

• The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.

  The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea 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 (19)

• The effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline

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

• The percentage of subjects who are identified as responders, defined as archiving an average ≥1 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores

  Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period

• The percentage of subjects who are identified as responders, defined as archiving an average ≥0.5 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores

  Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period

• The percentage of subjects who are identified as responders, defined as achieving an average ≥30% reduction from baseline for each of following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores

  Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period

• The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores.

  Over the 12-week Treatment Period

Study Arms (3)

CIN-102: 15mg

EXPERIMENTAL

15 mg CIN-102, taken orally BID for 12 weeks

Drug: CIN-102 Dose 15mg

CIN-102: 10mg

EXPERIMENTAL

10 mg CIN-102, taken orally BID for 12 weeks

Drug: CIN-102 Dose 10mg

Placebo for CIN-102

PLACEBO COMPARATOR

Placebo for CIN-102, taken orally BID for 12 weeks

Drug: Placebo

Interventions

CIN-102 Dose 15mg DRUG

Twice daily for 12 weeks

CIN-102: 15mg

Placebo DRUG

Twice daily for 12 weeks

Placebo for CIN-102

CIN-102 Dose 10mg DRUG

Twice daily for 12 weeks

CIN-102: 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 current diagnosis of gastroparesis defined by the following:
• Persistent gastrointestinal (GI) 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) at Visit 2.
• Body mass index between 17 and 49 kg/m2, inclusive;
• If receiving treatment with a Food and Drug Administration (FDA)-approved and marketed glucagon-like peptide-1 receptor agonist (GLP-1RA) for weight loss or reduce risk of major adverse cardiovascular events, and/or, receiving any other agent(s) taken for weight loss, subjects may be considered for the study if ALL of the following criteria are satisfied:
• Is not taking the agent(s) for the management of diabetes or blood glucose;
• Has been on a stable dose of the agent(s) for at least 3 months before Screening and is expected to maintain the same dose throughout the study, including during GEBT;
• Is tolerating the agent(s) well, according to the Investigator's judgment;
• In the opinion of the Investigator, the study-qualifying signs/symptoms of gastroparesis are NOT solely due to the the agent(s); and
• Symptoms of gastroparesis were present before starting the agent(s).
• \-------------------------------------------------------------------------

You may not qualify if:

• Has a known primary cause of gastroparesis (eg, diabetes, surgery; acute, ongoing, or active viral illness; cancer, medications, musculoskeletal or connective tissue disorders \[eg, scleroderma, systemic lupus erythematosus\], or other neurologic disorder \[eg, Parkinson's disease\], postural orthostatic tachycardia syndrome (POTS), etc.\]);
• Has been hospitalized for gastroparesis or malnutrition within 3 months prior to Screening;
• Has a known or suspected GI mechanical obstruction (eg, peptic stricture) as documented by upper GI endoscopy, upper GI radiographic series, plain film abdomen X-ray, or computed tomography (CT) in the past 2 years prior to Randomization;
• Has a history of pyloric injection of botulinum toxin within 6 months of Screening or planned injection(s) during the study;
• Has any history of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy (G-POEM) procedure;
• Has a history of gastric surgery;
• Has a history of or current diagnosis of intestinal malabsorption, recurrent or chronic pancreatitis, or other pancreatic exocrine disease;
• Has a history of severe and refractory constipation;
• Has a history or evidence of clinically significant arrhythmia;
• Currently receiving parenteral feeding or presence of a nasogastric or other gastric enteral tube (e.g. percutaneous endoscopic gastrostomy \[PEG\] or percutaneous endoscopic jejunostomy \[PEJ\] tube) for feeding or decompression; Note: patients receiving enteral feeding via a jejunostomy tube may be included if, in the opinion of the Investigator, the patient is also taking substantial oral solid intake and are not primarily dependent on enteral nutrition
• Has a substance use disorder or a positive alcohol or positive drug screen.

Sponsors & Collaborators

• CinDome Pharma, Inc.: lead

Study Sites (85)

Gastro Health - Birmingham

Birmingham, Alabama, 35235, United States

Location

G & L Research, LLC

Foley, Alabama, 36535, United States

Location

The Center for Clinical Trials

Saraland, Alabama, 36571, United States

Location

Del Sol Research Management, LLC

Tucson, Arizona, 85715, United States

Location

Applied Research Center of Arkansas, Inc

Little Rock, Arkansas, 72205, United States

Location

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

Hope Clinical Research LLC

Canoga Park, California, 91303, United States

Location

Erick H. Alayo Medical Corporation

Chula Vista, California, 91910, United States

Location

Flourish Research - Los Angeles (Covina)

Covina, California, 91723, United States

Location

Gastro Care Institute

Lancaster, California, 93534, United States

Location

Downtown L.A. Research Center, Inc.

Los Angeles, California, 90017, United States

Location

Acclaim Clinical Research

San Diego, California, 92120, United States

Location

Focus Clinical Research - West Hills

West Hills, California, 91307, United States

Location

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Gastroenterology (RMG)

Lakewood, Colorado, 80228, United States

Location

Paradigm Research - Wheatridge

Wheat Ridge, Colorado, 80033, United States

Location

Connecticut Clinical Research Institute, LLC

Bristol, Connecticut, 06010, United States

Location

American Family Research Group

Cape Coral, Florida, 33909, United States

Location

USA and International Research Inc.

Doral, Florida, 33126, United States

Location

Unique Clinical Trials

Doral, Florida, 33172, United States

Location

Advanced Medical Research Group

Hollywood, Florida, 33021, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

ENCORE Borland Groover Clinical Research

Jacksonville, Florida, 32256, United States

Location

Allied Biomedical Research Institute, Inc.

Miami, Florida, 33155, United States

Location

Advanced Research Institute Inc

New Port Richey, Florida, 34653, United States

Location

Sensible Healthcare, LLC

Ocoee, Florida, 34761, United States

Location

GCP Research

St. Petersburg, Florida, 33705, United States

Location

Summit Clinical Research, LLC

Athens, Georgia, 30607, United States

Location

DelRicht Clinical Research - Atlanta

Atlanta, Georgia, 30329, United States

Location

Gastrointestinal Specialists of Georgia PC

Marietta, Georgia, 30060, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

GI Alliance - Gurnee

Gurnee, Illinois, 60031, United States

Location

Carle Clinic - Urbana Main

Urbana, Illinois, 61801, United States

Location

Integrated Clinical Trial Services, Inc

West Des Moines, Iowa, 50265, United States

Location

Kansas Medical Clinic, P.A.

Topeka, Kansas, 66606, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Delta Research Partners of West Monroe, LLC

Monroe, Louisiana, 71201, United States

Location

NOLA Research Works

New Orleans, Louisiana, 70125, United States

Location

Portland Gastroenterology Associates

Portland, Maine, 04101, United States

Location

Capital Digestive Care - Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Sanmora Bespoke: Parkway Medical Association

Glen Burnie, Maryland, 21061, United States

Location

Gastro Health - Framingham

Framingham, Massachusetts, 01702, United States

Location

Aa Mrc, Llc

Flint, Michigan, 48504, United States

Location

Huron Gastroenterology

Ypsilanti, Michigan, 48197, United States

Location

Gastrointestinal Associates and Endoscopy Center, PA - Flowood

Flowood, Mississippi, 39232, United States

Location

KAD Clinical Research, LLC

St Louis, Missouri, 63123, United States

Location

St. Charles Clinical Research

Weldon Spring, Missouri, 63304, United States

Location

Quality Clinical Research, Inc

Omaha, Nebraska, 68114, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Digestive Disease Specialists

Las Vegas, Nevada, 89128, United States

Location

Advanced Research Institute - Reno

Reno, Nevada, 89511, United States

Location

Southwest Gastroenterology Associates

Albuquerque, New Mexico, 87109, United States

Location

NY Scientific

Brooklyn, New York, 11235, United States

Location

Westchester Putnam Gastro

Carmel, New York, 10512, United States

Location

Atrium Health - Center for Gastroenterology and Hepatology MMP

Charlotte, North Carolina, 28204, United States

Location

Cross Creek Medical Clinic, PA

Fayetteville, North Carolina, 28304, United States

Location

Carolina Digestive Diseases & Endoscopy Center

Greenville, North Carolina, 27834, United States

Location

Peters Medical Research

High Point, North Carolina, 27260, United States

Location

Hometown Urgent Care and Research (Cincinnati)

Cincinnati, Ohio, 45150, United States

Location

Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health - Columbus

Columbus, Ohio, 43228, United States

Location

Hometown Urgent Care and Research - Huber Heights

Huber Heights, Ohio, 45424, United States

Location

Gastro Intestinal Research Institute of Northern Ohio, LLC

Westlake, Ohio, 44145, United States

Location

Options Health Research

Tulsa, Oklahoma, 74104, United States

Location

Advanced Research Institute - Portland

Portland, Oregon, 97223, United States

Location

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, 17110, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Frontier Clinical Research, LLC - Smithfield

Smithfield, Pennsylvania, 15478, United States

Location

PPCP Division of Gastroenterology

Summerville, South Carolina, 29486, United States

Location

Galen Medical Group

Hixson, Tennessee, 37343, United States

Location

Digestive Health - UT Health Austin

Austin, Texas, 78712, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

EPIC Medical Research

DeSoto, Texas, 75115, United States

Location

Amir A Hassan, MD, PA

Houston, Texas, 77089, United States

Location

Pioneer Research Solutions Inc.

Houston, Texas, 77099, United States

Location

Epic Clinical Research

Lewisville, Texas, 75057, United States

Location

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

North Richland Hills, Texas, 76180, United States

Location

Bandera Family HealthCare Research, LLC (BFHC)

San Antonio, Texas, 78249, United States

Location

GI Alliance - Texas Digestive Disease Consultants - San Marcos

San Marcos, Texas, 78666, United States

Location

Texas Digestive Specialists

Texas City, Texas, 78550, United States

Location

Advanced Research Institute - Ogden

Ogden, Utah, 84405, United States

Location

Advanced Research Institute - Sandy

Sandy City, Utah, 84092, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Capital Digestive Center

Norfolk, Virginia, 23502, United States

Location

Advocate Aurora Health Research Institute

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Gastroparesis; Vomiting; Abdominal Pain; Nausea

Condition Hierarchy (Ancestors)

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

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: February 14, 2025
• First Posted: March 27, 2025
• Study Start: January 29, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (85)