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

Launched by CINDOME PHARMA, INC. · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called CIN-102 (deudomperidone) to see if it can help reduce nausea in adults with idiopathic gastroparesis, a condition that affects how the stomach empties food. The study aims to determine whether this drug is effective compared to a placebo (a treatment that has no active ingredients) and to assess its safety. Participants will take the medication twice a day for 12 weeks and will be monitored through various tests and daily diaries to track their symptoms.

To join this study, participants must be adults aged 18 or older who have been diagnosed with gastroparesis and have shown signs of delayed stomach emptying in a specific test. However, they shouldn't have other known causes for their condition, such as diabetes or recent surgeries. The trial is not yet recruiting participants, but those who do join will have regular visits over the course of the study to receive the drug and report on their experiences. This could be an important opportunity for individuals looking for new treatment options for their symptoms.

Gender

ALL

Eligibility criteria

• 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 45 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, may be considered for the study if ALL of the following criteria are satisfied:
• • 1. Has been on a stable dose of GLP-1RA for at least 3 months before Screening and is expected to maintain the same dose throughout the study, including during GEBT;
• • 2. Is tolerating the GLP-1RA well, according to the Investigator's judgment;
• • 3. In the opinion of the Investigator, the study-qualifying signs/symptoms of gastroparesis are NOT solely due to the GLP-1RA;
• • 4. Symptoms of gastroparesis were present before starting GLP-1RA therapy; and
• • 5. Is not taking the GLP-1RA for the management of diabetes or blood glucose control.
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• 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 \[eg, Parkinson's disease\]);
• • 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 enteral tube (e.g. percutaneous endoscopic gastrostomy \[PEG\] or percutaneous endoscopic jejunostomy \[PEJ\] tube) for feeding or decompression;
• • Has a substance use disorder or a positive alcohol or positive drug screen.