A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.
NCT ID: NCT06899217
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
400 participants
INTERVENTIONAL
2025-01-29
2026-06-23
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CIN-102: 15mg
15 mg CIN-102, taken orally BID for 12 weeks
CIN-102 Dose 15mg
Twice daily for 12 weeks
CIN-102: 10mg
10 mg CIN-102, taken orally BID for 12 weeks
CIN-102 Dose 10mg
Twice daily for 12 weeks
Placebo for CIN-102
Placebo for CIN-102, taken orally BID for 12 weeks
Placebo
Twice daily for 12 weeks
Interventions
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CIN-102 Dose 15mg
Twice daily for 12 weeks
Placebo
Twice daily for 12 weeks
CIN-102 Dose 10mg
Twice daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Has a current diagnosis of gastroparesis defined by the following:
1. Persistent gastrointestinal (GI) 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) 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:
1. Is not taking the agent(s) for the management of diabetes or blood glucose;
2. 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;
3. Is tolerating the agent(s) well, according to the Investigator's judgment;
4. In the opinion of the Investigator, the study-qualifying signs/symptoms of gastroparesis are NOT solely due to the the agent(s); and
5. Symptoms of gastroparesis were present before starting the agent(s).
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Exclusion Criteria
* Has a current diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association. Pre-diabetes is not exclusionary;
* 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.
18 Years
ALL
No
Sponsors
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CinDome Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Gastro Health - Birmingham
Birmingham, Alabama, United States
G & L Research, LLC
Foley, Alabama, United States
The Center for Clinical Trials
Saraland, Alabama, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
Applied Research Center of Arkansas, Inc
Little Rock, Arkansas, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Hope Clinical Research LLC
Canoga Park, California, United States
Erick H. Alayo Medical Corporation
Chula Vista, California, United States
Flourish Research - Los Angeles (Covina)
Covina, California, United States
Gastro Care Institute
Lancaster, California, United States
Downtown L.A. Research Center, Inc.
Los Angeles, California, United States
Acclaim Clinical Research
San Diego, California, United States
Focus Clinical Research - West Hills
West Hills, California, United States
University of Colorado Anschutz
Aurora, Colorado, United States
Rocky Mountain Gastroenterology (RMG)
Lakewood, Colorado, United States
Paradigm Research - Wheatridge
Wheat Ridge, Colorado, United States
Connecticut Clinical Research Institute, LLC
Bristol, Connecticut, United States
American Family Research Group
Cape Coral, Florida, United States
USA and International Research Inc.
Doral, Florida, United States
Unique Clinical Trials
Doral, Florida, United States
Advanced Medical Research Group
Hollywood, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
ENCORE Borland Groover Clinical Research
Jacksonville, Florida, United States
Allied Biomedical Research Institute, Inc.
Miami, Florida, United States
Advanced Research Institute Inc
New Port Richey, Florida, United States
Sensible Healthcare, LLC
Ocoee, Florida, United States
GCP Research
St. Petersburg, Florida, United States
Summit Clinical Research, LLC
Athens, Georgia, United States
DelRicht Clinical Research - Atlanta
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
GI Alliance - Gurnee
Gurnee, Illinois, United States
Carle Clinic - Urbana Main
Urbana, Illinois, United States
Integrated Clinical Trial Services, Inc
West Des Moines, Iowa, United States
Kansas Medical Clinic, P.A.
Topeka, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Delta Research Partners of West Monroe, LLC
Monroe, Louisiana, United States
NOLA Research Works
New Orleans, Louisiana, United States
Portland Gastroenterology Associates
Portland, Maine, United States
Capital Digestive Care - Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Sanmora Bespoke: Parkway Medical Association
Glen Burnie, Maryland, United States
Gastro Health - Framingham
Framingham, Massachusetts, United States
Aa Mrc, Llc
Flint, Michigan, United States
Huron Gastroenterology
Ypsilanti, Michigan, United States
Gastrointestinal Associates and Endoscopy Center, PA - Flowood
Flowood, Mississippi, United States
KAD Clinical Research, LLC
St Louis, Missouri, United States
St. Charles Clinical Research
Weldon Spring, Missouri, United States
Quality Clinical Research, Inc
Omaha, Nebraska, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Digestive Disease Specialists
Las Vegas, Nevada, United States
Advanced Research Institute - Reno
Reno, Nevada, United States
Southwest Gastroenterology Associates
Albuquerque, New Mexico, United States
NY Scientific
Brooklyn, New York, United States
Westchester Putnam Gastro
Carmel, New York, United States
Atrium Health - Center for Gastroenterology and Hepatology MMP
Charlotte, North Carolina, United States
Cross Creek Medical Clinic, PA
Fayetteville, North Carolina, United States
Carolina Digestive Diseases & Endoscopy Center
Greenville, North Carolina, United States
Peters Medical Research
High Point, North Carolina, United States
Hometown Urgent Care and Research (Cincinnati)
Cincinnati, Ohio, United States
Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health - Columbus
Columbus, Ohio, United States
Hometown Urgent Care and Research - Huber Heights
Huber Heights, Ohio, United States
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake, Ohio, United States
Options Health Research
Tulsa, Oklahoma, United States
Advanced Research Institute - Portland
Portland, Oregon, United States
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Frontier Clinical Research, LLC - Smithfield
Smithfield, Pennsylvania, United States
PPCP Division of Gastroenterology
Summerville, South Carolina, United States
Galen Medical Group
Hixson, Tennessee, United States
Digestive Health - UT Health Austin
Austin, Texas, United States
Zenos Clinical Research
Dallas, Texas, United States
EPIC Medical Research
DeSoto, Texas, United States
Amir A Hassan, MD, PA
Houston, Texas, United States
Pioneer Research Solutions Inc.
Houston, Texas, United States
Epic Clinical Research
Lewisville, Texas, United States
North Hills Medical Research Inc. (North Hills Family Medicine)
North Richland Hills, Texas, United States
Bandera Family HealthCare Research, LLC (BFHC)
San Antonio, Texas, United States
GI Alliance - Texas Digestive Disease Consultants - San Marcos
San Marcos, Texas, United States
Texas Digestive Specialists
Texas City, Texas, United States
Advanced Research Institute - Ogden
Ogden, Utah, United States
Advanced Research Institute - Sandy
Sandy City, Utah, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Capital Digestive Center
Norfolk, Virginia, United States
Advocate Aurora Health Research Institute
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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CIN-102-124
Identifier Type: -
Identifier Source: org_study_id
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