Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.
Lead Sponsor:
CinDome Pharma, Inc.
Conditions:
Idiopathic Gastroparesis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Key
- 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).
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- Key
Exclusion
- 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.
Key Trial Info
Start Date :
January 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 23 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06899217
Start Date
January 29 2025
End Date
June 23 2026
Last Update
January 8 2026
Active Locations (85)
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1
Gastro Health - Birmingham
Birmingham, Alabama, United States, 35235
2
G & L Research, LLC
Foley, Alabama, United States, 36535
3
The Center for Clinical Trials
Saraland, Alabama, United States, 36571
4
Del Sol Research Management, LLC
Tucson, Arizona, United States, 85715