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ACTIVE NOT RECRUITING

NCT06899217

PHASE2

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

Sponsor: CinDome Pharma, Inc.

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

416

Start Date

2025-01-29

Completion Date

2026-05-01

Last Updated

2026-02-23

Healthy Volunteers

Conditions

Idiopathic Gastroparesis

Interventions

DRUG

CIN-102 Dose 15mg

Twice daily for 12 weeks

DRUG

Placebo

Twice daily for 12 weeks

DRUG

CIN-102 Dose 10mg

Twice daily for 12 weeks

Key Inclusion Criteria: * Is a male or female ≥18 years of age; * 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). \------------------------------------------------------------------------- Key Exclusion Criteria: * 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 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.

Locations (85)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (85)