A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help reduce the symptoms associated with diabetic gastroparesis in adult patients. The main questions it aims to answer are: To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with diabetic gastroparesis compared to a placebo To evaluate the safety and tolerability of CIN-102 when given to patients with diabetic gastroparesis compared to a placebo Participants will go through the following schedule: Screening period (1-2 visits) Lead-in period (1 visit) 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 12-week treatment period (5 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: Drug- CIN-102 Dose 1 Drug- CIN-102 Dose 2 Drug- Placebo

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

Conditions
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Diabetic Gastroparesis

Intervention / Treatment
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* Drug: CIN-102 Dose 1
* Drug: CIN-102 Dose 2
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Is a male or female ≥18 years of age; Has a diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association criteria; Has a current diagnosis of diabetic gastroparesis defined by the following: Gastrointestinal symptoms felt to be consistent with gastroparesis within 6 months prior to Screening; AND Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT), scintigraphy, or manometry. Body mass index (BMI) between 18 and 45 kg/m2, inclusive; Glycosylated hemoglobin (HbA1c) level <10% at Screening; Willing to washout from ongoing treatment for gastroparesis. Key Exclusion Criteria: Has known cause of gastroparesis other than diabetes (eg, idiopathic gastroparesis and/or gastroparesis attributed to surgery, viral illness, cancer, scleroderma, or other neurologic disorder); History or evidence of clinically significant arrhythmia; History of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy, fundoplication, gastrectomy, vagotomy, or bariatric surgery; Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression; Pyloric injection of botulinum toxin within 6 months of Screening; Positive test for drugs of abuse; Has a known allergy to eggs or spirulina; Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CIN-102 Dose 1<br>Dose 1 twice daily for 12 weeks | Drug: CIN-102 Dose 1<br>* 2 capsules twice daily for 12 weeks<br>|
| Experimental: CIN-102 Dose 2<br>Dose 2 twice daily for 12 weeks | Drug: CIN-102 Dose 2<br>* 2 capsules twice daily for 12 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo twice daily for 12 weeks | Drug: Placebo<br>* 2 capsules twice daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline based on the composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores | The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea Subscale scores and the Vomiting subscale scores will be averaged into a single value that ranges 0-4 (0 for no symptom and 4 for very severe) | Over the last 2 weeks of the 12-week Treatment Period as compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of clinically significant changes, in the Investigator's opinion, in laboratory parameters, physical examination findings, 12-lead ECG parameters, weight measurement. |  | Over the 12-week Treatment Period | 
| Incidence of treatment-emergent adverse events (TEAEs) |  | Over the 12-week Treatment Period | 
| Incidence of treatment emergent Serious Adverse Events (SAEs) |  | Over the 12-week Treatment Period | 
| Incidence of TEAEs leading to premature discontinuation of study drug |  | Over the 12-week Treatment Period | 
| Incidence of treatment-emergent marked laboratory abnormalities. |  | Over the 12-week Treatment Period | 
| Estimates based on a composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores using Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) as an anchor Sub-Scale | Justification for obtaining estimates using both PGIS and PGIC is provide accumulated evidence to help interpret a clinically meaningful within-patient score change as outcome anchors. | Over the last 2 weeks for the 12-week Treatment Period | 
| Percentage of subjects with a history of a lack of response or who could not tolerate metoclopramide therapy or other prokinetics, who demonstrate a >30% reduction on a composite score | Composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores | Over the last 2 weeks of the 12-week Treatment Period as compared to baseline | 
| Percentage of subjects who are identified as responders, defined as an average ≥0.5 reduction from baseline on their ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores |  | Over the last 2 weeks of the 12-week Treatment Period | 
| Percentage of subjects achieving a ≥30% reduction from baseline on a composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores |  | Over the last 2 weeks of the 12-week Treatment Period | 
| Percentage of subjects achieving a ≥30% reduction from baseline on the average ANMS GCSI-DD Vomiting Sub-Scale Score |  | Over the last 2 weeks of the 12-week Treatment Period | 
| Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline | Based on the average ANMS GCSI-DD Nausea Sub-Scale Score | Over the last 2 weeks of the 12-week Treatment Period as compared to baseline | 
| Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline | Based on the average ANMS GCSI-DD Vomiting Sub-Scale Score | Over the last 2 weeks of the 12-week Treatment Period as compared to baseline | 
| Percentage of subjects achieving a ≥30% reduction from baseline on the average ANMS GCSI-DD Nausea Sub-Scale Score |  | Over the last 2 weeks of the 12-week Treatment Period | 
| Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms | Based on the average ANMS GCSI-DD Total Score | Over the last 2 weeks of the 12-week Treatment Period as compared to baseline | 
| Percentage of subjects achieving a ≥30% reduction on the average ANMS GCSI-DD Total Score |  | Over the last 2 weeks of the 12-week Treatment Period as compared to baseline | 
| Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms based on the ANMS GCSI-DD Early Satiety Sub-Scale Score | Average ANMS GCSI-DD Early Satiety Sub-Scale Score | Over the last 2 weeks of the 12-week Treatment Period as compared to baseline | 
| Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms | Based on the average ANMS GCSI-DD Postprandial Fullness Sub-Scale Score | Over the last 2 weeks of the 12-week Treatment Period as compared to baseline | 
| Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms | Based on the average ANMS GCSI-DD Upper Abdominal Pain Sub-Scale Score | Over the last 2 weeks of the 12-week Treatment Period as compared to baseline | 
| Percentage of symptom-free days in the ANMS GCSI-DD Total Score, a composite of the Nausea and Vomiting Scores, Nausea Score, Vomiting Score, Early Satiety Score, Postprandial Fullness Score, and Upper Abdominal Pain Score with each dose of CIN-102 | Symptomatic days defined as >mild (ANMS GCSI-DD scores >2) | Over the last 2 weeks of the 12-week Treatment Period | 
| All endpoints that are evaluated over the last 2 weeks of the 12-week Treatment period will also be evaluated over the last 6 weeks of the 12-week Treatment period. |  | Over the last 6 weeks of the 12-week Treatment Period | 
| Change in the PGIS with each dose of CIN-102 |  | From baseline to Week 12 | 
| Change in the PGIC with each dose of CIN-102 |  | From baseline to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroparesis, Diabetic gastroparesis, Gastrointestinal disease, Delayed gastric emptying, Digestive system diseases, Nausea, Vomiting, Stomach, Dopamine receptor antagonist