NCT06899217 - A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis. | Crick

Eligibility

Sex: ALLMin age: 18 Years

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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.

Outcomes

Primary Outcomes

The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.

The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea Subscale Scores will be averaged into a single value that ranges 0-4 (0 for no symptom and 4 for very severe).

Time frame: Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline

Secondary Outcomes

The effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline

Based on the average ANMS GCSI-DD Total Score, Composite of the Nausea and Vomiting Scores, Vomiting Score, Early Satiety Score, Postprandial Fullness Score, upper Abdominal Pain Score, and Vomiting Severity Score

Time frame: Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline

The percentage of subjects who are identified as responders, defined as archiving an average ≥1 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores

• The percentage of subjects achieving an average ≥1 point reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores

Time frame: Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period

The percentage of subjects who are identified as responders, defined as archiving an average ≥0.5 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores

• The percentage of subjects achieving an average ≥0.5 point reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores

Time frame: Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period

The percentage of subjects who are identified as responders, defined as achieving an average ≥30% reduction from baseline for each of following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores

• Occurrence of subjects achieving an average ≥ 30% reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores

Time frame: Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period

The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores.

A symptom-free day is defined as a day with severity of symptoms assessed as "none" \[ie, ANMS GCSI-DD scores of 0\])

Time frame: Over the 12-week Treatment Period

The percentage of symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores

A symptomatic week is defined as average ANMS GCSI-DD score ≥ 1

Time frame: Over the 12-week Treatment Period

The percentage of mild, moderate, severe and very severe symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores

Sponsor to provide definition of each severity score

Time frame: Over the 12-week Treatment Period

The Patient Global Impression of Change (PGIC) value

• The absolute change in PGIC over the 12-week Treatment Period

Time frame: Over the 12-week Treatment Period

The Patient Global Impression of Severity (PGIS) value

• The absolute change from baseline to Week 12 in PGIS

Time frame: From baseline to Week 12

The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.

Time frame: Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline

The effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline

Time frame: Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline

The percentage of subjects identified as responders, defined as an average ≥0.5 reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, vomiting severity scores

• Occurrence of subjects with an average ≥ 0.5 reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores

Time frame: Over the last 6 weeks of the 12-week Treatment Period

The percentage of subjects identified as responders, defined as achieving ≥30% reduction from baseline for each: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, vomiting severity scores

• Occurrence of subjects achieving a ≥ 30% reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores