Diabetic Gastroparesis
Conditions
Keywords
Gastroparesis, Diabetic gastroparesis, Gastrointestinal disease, Delayed gastric emptying, Digestive system diseases, Nausea, Vomiting, Stomach, Dopamine receptor antagonist
Brief summary
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 (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: * Drug- CIN-102 Dose 15 mg or 10 mg * Drug- Placebo
Interventions
DRUGCIN-102 Dose 15mg or 10mg
2 capsules twice daily for 12 weeks
DRUGPlacebo
2 capsules twice daily for 12 weeks
Sponsors
CinDome Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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: 1. Persistent gastrointestinal 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), scintigraphy, or manometry. * Body mass index (BMI) between 18 and 49 kg/m2, inclusive; * Glycosylated hemoglobin (HbA1c) level \<10% at Screening; * If receiving treatment with GLP-1RA, may be considered for the study if all of the following criteria are satisfied: 1. The GLP-1 RA has been prescribed for the management of diabetes and not specifically for weight loss/weight management; 2. Has been on a stable dose of GLP-1RA for a minimum of 3 months before Screening and is anticipated to sustain the same dose during GEBT and throughout the study; 3. Is tolerating the GLP-1RA well based on Investigator's judgment; 4. None of the study-qualifying signs/symptoms of gastroparesis are solely attributable to the use of GLP-1RA; and 5. The symptoms of gastroparesis preceded the initiation of GLP-1RA therapy. * 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); * Has been hospitalized within 3 months prior to Visit 1 for diabetic gastroparesis and/or diabetic ketoacidosis and/or malnutrition; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of CIN-102 to significantly decrease gastroparesis-related symptoms as compared to baseline based on the composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores | Over the last 2 weeks of the 12-week Treatment Period as compared to baseline | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Percentage of responders who demonstrate an average ≥0.5 reduction from baseline on the ANMS GCSI-DD Nausea Sub-Scale and Vomiting 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 Scores | Over the last 2 weeks of the 12-week Treatment Period | — |
| The percentage of symptom-free days in the ANMS GCSI-DD Total Score, a composite of the Nausea Sub-Scale and Vomiting Scores, and Sub-Scale Scores | Over the last 2 weeks of the 12-week Treatment Period | Symptomatic days defined as \>mild (ANMS GCSI-DD scores \>2) |
| The percentage of responders among subjects receiving GLP-1RA who demonstrate an average ≥0.5 reduction from baseline on the ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores | Over the last 2 weeks of 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 from baseline on a composite score | Over the last 2 weeks of the 12-week Treatment Period as compared to baseline | Composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores |
| The percentage of subjects receiving GLP-1RA who achieve a ≥30% reduction from baseline on the ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores | 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 | Over the last 2 weeks of the 12-week Treatment Period as compared to baseline | Based on the average ANMS GCSI-DD Total and Sub-Scale Scores |
| The change in the composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores among subjects receiving glucagon-like peptide-1 receptor agonist (GLP-1RA) | Over the 12-week Treatment Period as compared to baseline | — |
| The change in the ANMS GSCI-DD Total Score and a composite of gastroparesis-related symptoms among subjects receiving GLP-1RA; | over the last 2 weeks of the 12-week Treatment Period, as compared to baseline | — |
| 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 | — |
| The relationship between ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores and Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) over the 12-week Treatment Period; | Over the 12-week Treatment Period | — |
Countries
United States
Outcome results
None listed