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

• Sponsor: CinDome Pharma, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05832151
• Collaborator: (none)
• Enrollment: 400
• Locations: 20
• Arms: 3
• Anticipated Duration (Months): 19.2
• Patients Per Site: 20
• Patients Per Site Per Month: 1

Study Details

Study Description

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 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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Gastroparesis	Drug: CIN-102 Dose 1; Drug: CIN-102 Dose 2; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 27, 2023
• Anticipated Primary Completion Date: Oct 23, 2024
• Anticipated Study Completion Date: Oct 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CIN-102 Dose 1 Dose 1 twice daily for 12 weeks	Drug: CIN-102 Dose 1; 2 capsules twice daily for 12 weeks
Experimental: CIN-102 Dose 2 Dose 2 twice daily for 12 weeks	Drug: CIN-102 Dose 2; 2 capsules twice daily for 12 weeks
Placebo Comparator: Placebo Placebo twice daily for 12 weeks	Drug: Placebo; 2 capsules twice daily for 12 weeks

Outcome Measures

Primary Outcome Measures

1. 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 [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 Outcome Measures

1. 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]

2. Incidence of treatment-emergent adverse events (TEAEs) [Over the 12-week Treatment Period]

3. Incidence of treatment emergent Serious Adverse Events (SAEs) [Over the 12-week Treatment Period]

4. Incidence of TEAEs leading to premature discontinuation of study drug [Over the 12-week Treatment Period]

5. Incidence of treatment-emergent marked laboratory abnormalities. [Over the 12-week Treatment Period]

6. 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 [Over the last 2 weeks for the 12-week Treatment Period]

   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.

7. 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 [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 Sub-Scale Scores

8. 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]

9. 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]

10. 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]

11. 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 Nausea Sub-Scale Score

12. 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 Vomiting Sub-Scale Score

13. 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]

14. Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms [Over the last 2 weeks of the 12-week Treatment Period as compared to baseline]

    Based on the average ANMS GCSI-DD Total Score

15. 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]

16. Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms based on the ANMS GCSI-DD Early Satiety Sub-Scale Score [Over the last 2 weeks of the 12-week Treatment Period as compared to baseline]

    Average ANMS GCSI-DD Early Satiety Sub-Scale Score

17. Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms [Over the last 2 weeks of the 12-week Treatment Period as compared to baseline]

    Based on the average ANMS GCSI-DD Postprandial Fullness Sub-Scale Score

18. Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms [Over the last 2 weeks of the 12-week Treatment Period as compared to baseline]

    Based on the average ANMS GCSI-DD Upper Abdominal Pain Sub-Scale Score

19. 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 [Over the last 2 weeks of the 12-week Treatment Period]

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

20. 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]

21. Change in the PGIS with each dose of CIN-102 [From baseline to Week 12]

22. Change in the PGIC with each dose of CIN-102 [From baseline to Week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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. Gastrointestinal symptoms felt to be consistent with gastroparesis within 6 months prior to Screening; AND

2. Documented delayed gastric emptying within the past 2 years or willing to complete a gastric emptying breath test.

• 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;

• Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adobe Clinical Research, LLC	Tucson	Arizona	United States	85712
2	Aurora Care Clinic	Costa Mesa	California	United States	92627
3	Innovative Research of West Florida	Clearwater	Florida	United States	33756
4	USA and International Research Inc.	Doral	Florida	United States	33126
5	Advanced Medical Research Group	Hollywood	Florida	United States	33021
6	ClinCloud LLC	Maitland	Florida	United States	32751
7	A+ Research Inc	Miami	Florida	United States	33144
8	International Research Associates LLC - Breton	Miami	Florida	United States	33183
9	Advanced Research Institute Inc	New Port Richey	Florida	United States	34653
10	Tandem Clinical Research - Viera	Viera	Florida	United States	32940
11	Tandem Clinical Research GI - Houma	Houma	Louisiana	United States	70363
12	Tandem Clinical Research GI - Metairie	Metairie	Louisiana	United States	70006
13	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan	United States	48047
14	Aa Mrc, Llc	Flint	Michigan	United States	48504
15	Gastroenterology Associates of Western Michigan	Wyoming	Michigan	United States	49519
16	American Institute of Medical Research	Las Vegas	Nevada	United States	89123
17	Long Island Gastrointestinal Research Group	Great Neck	New York	United States	11023
18	Options Health Research	Tulsa	Oklahoma	United States	74104
19	Care and Cure Clinic	Houston	Texas	United States	77090
20	Manassas Clinical Research Center	Manassas	Virginia	United States	20110

Sponsors and Collaborators

• CinDome Pharma, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CinDome Pharma, Inc.
• ClinicalTrials.gov Identifier: NCT05832151
• Other Study ID Numbers: CIN-102-123
• First Posted: Apr 27, 2023
• Last Update Posted: Apr 27, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by CinDome Pharma, Inc.: Gastroparesis; Diabetic gastroparesis; Gastrointestinal disease; Delayed gastric emptying; Digestive system diseases; Nausea; Vomiting; Stomach; Dopamine receptor antagonist
• Additional relevant MeSH terms: Gastroparesis

Study Results

No Results Posted as of Apr 27, 2023