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