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

CinDome Pharma, Inc.382 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

382

Conditions

Diabetic Gastroparesis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (100)

Digestive Health Specialists of the Southeast

Dothan, Alabama, United States

G & L Research, LLC

Foley, Alabama, United States

Clinical Research Associates, LLC

Huntsville, Alabama, United States

Phoenix Medical Research Institute, LLC

Peoria, Arizona, United States

Onyx Clinical Research

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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

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)

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

Secondary Outcomes

Incidence of clinically significant changes, in the Investigator's opinion, in laboratory parameters, physical examination findings, 12-lead ECG parameters, weight measurement.

Time frame: Over the 12-week Treatment Period

Incidence of treatment-emergent adverse events (TEAEs)

Time frame: Over the 12-week Treatment Period

Incidence of treatment emergent Serious Adverse Events (SAEs)

Time frame: Over the 12-week Treatment Period

Incidence of TEAEs leading to premature discontinuation of study drug

Time frame: Over the 12-week Treatment Period

Incidence of treatment-emergent marked laboratory abnormalities.

Time frame: 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

Time frame: 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

Time frame: 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

Symptomatic days defined as \>mild (ANMS GCSI-DD scores \>2)

Time frame: Over the last 2 weeks of the 12-week Treatment Period

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;

Time frame: Over 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

Composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores

Time frame: 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 Total and Sub-Scale Scores

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

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)

Time frame: Over the 12-week Treatment Period as compared to baseline

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

Time frame: Over the last 2 weeks of the 12-week Treatment Period

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

Time frame: Over the last 2 weeks of the 12-week Treatment Period

The change in the ANMS GSCI-DD Total Score and a composite of gastroparesis-related symptoms among subjects receiving GLP-1RA;

Time frame: 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.

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

Change in the PGIS with each dose of CIN-102

Time frame: From baseline to Week 12

Change in the PGIC with each dose of CIN-102

Time frame: From baseline to Week 12