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

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
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Short title: A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis
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Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Diabetic Gastroparesis
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Control arm: Placebo
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Registry reports results: No
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Listing at source: Listed
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Recruitment status: Completed
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Phase: Phase 2
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Study type: Interventional
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Completion date: 2025-12-12
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First posted: 2023-04-27
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Registry last updated: 2025-12-17
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Primary completion date: 2025-11-14
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Start date: 2023-03-27
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Actual participants: 382
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Participants: 382
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Participant count basis: Actual
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Protocol amendments: 11
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Number of sites: 100
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Data monitoring committee: Yes
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Registry sponsor category: Industry
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Lead sponsor: CinDome Pharma, Inc.
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Source registry: ClinicalTrials.gov
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Registry ID: NCT05832151
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ClinicalTrials.gov ID: NCT05832151
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Registry record: Open registry record
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Allocation: Randomised
Model: Parallel groups
Purpose: Treatment
Masking: Quadruple masking
Masked roles: Participants, Care providers, Investigators, Outcome assessors

Sources for study design

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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
Timeframe: 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)

Incidence of clinically significant changes, in the Investigator's opinion, in laboratory parameters, physical examination findings, 12-lead ECG parameters, weight measurement.
Timeframe: Over the 12-week Treatment Period
Incidence of treatment-emergent adverse events (TEAEs)
Timeframe: Over the 12-week Treatment Period
Incidence of treatment emergent Serious Adverse Events (SAEs)
Timeframe: Over the 12-week Treatment Period
Incidence of TEAEs leading to premature discontinuation of study drug
Timeframe: Over the 12-week Treatment Period
Incidence of treatment-emergent marked laboratory abnormalities.
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Over the last 2 weeks of the 12-week Treatment Period
Symptomatic days defined as \>mild (ANMS GCSI-DD scores \>2)
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;
Timeframe: 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
Timeframe: 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
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Timeframe: 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;
Timeframe: 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.
Timeframe: Over the last 6 weeks of the 12-week Treatment Period
Change in the PGIS with each dose of CIN-102
Timeframe: From baseline to Week 12
Change in the PGIC with each dose of CIN-102
Timeframe: From baseline to Week 12

Sources for outcomes

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Sex: All
Age groups: Adults, Older adults
Minimum age: 18 Years
Healthy volunteers: No

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.

Sources for eligibility

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