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Completed NCT06899217

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

Conditions: Idiopathic Gastroparesis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 416
Sponsor: CinDome Pharma, Inc.

Location: Gastro Health - Birmingham Birmingham Alabama

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

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 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06899217). StuddyBuddy aggregates publicly available trial information.