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

Diabetic Gastroparesis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05832151
• Other study ID #: CIN-102-123
• Status: Recruiting
• Phase: Phase 2
• Start date: March 27, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: April 2024
• Source: CinDome Pharma, Inc.
• Contact: Rachael Farley
• Phone: +1.513.579.9911
• Email: R.Farley[@]Medpace.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 30, 2024
• Est. primary completion date: October 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 45 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. 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;

2. Is tolerating the GLP-1RA well based on Investigator's judgment;

3. None of the study-qualifying signs/symptoms of gastroparesis are solely attributable to the use of GLP-1RA; and

4. 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);
• 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.

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis

Intervention

Drug:
• CIN-102 Dose 1
2 capsules twice daily for 12 weeks
• CIN-102 Dose 2
2 capsules twice daily for 12 weeks
• Placebo
2 capsules twice daily for 12 weeks

Locations

Country	Name	City	State
United States	North Hills Medical Research Inc. (North Hills Familiy Medicine)	Arlington	Texas
United States	Summit Clinical Research, LLC	Athens	Georgia
United States	Delta Research Partners	Bastrop	Louisiana
United States	HP Clinical Research (Val R. Hansen)	Bountiful	Utah
United States	NY Scientific	Brooklyn	New York
United States	Smart Medical Research	Brooklyn	New York
United States	Alliance Research Institute, LLC	Canoga Park	California
United States	Hope Clinical Research LLC	Canoga Park	California
United States	Voyage Medical Services, PLLC- Canton, Mighica	Canton	Michigan
United States	Atrium Health - Center for Digestive Health	Charlotte	North Carolina
United States	OnSite Clinical Solutions, LLC	Charlotte	North Carolina
United States	Galen Medical Group - Downtown Gastroenterology Location	Chattanooga	Tennessee
United States	WR ClinSearch	Chattanooga	Tennessee
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Erick H. Alayo Medical Corporation	Chula Vista	California
United States	GW Research Inc.	Chula Vista	California
United States	Innovative Research of West Florida	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Remington Davis, Inc.	Columbus	Ohio
United States	Kindred Medical Institute for Clinical Trials, LLC	Corona	California
United States	New Hope Research Development	Corona	California
United States	Aurora Care Clinic	Costa Mesa	California
United States	Zenos Clinical Research	Dallas	Texas
United States	Atlanta Center for Gastroenterology P.C.	Decatur	Georgia
United States	Research Carolina Elite, LLC	Denver	North Carolina
United States	USA and International Research Inc.	Doral	Florida
United States	Digestive Health Specialists of the Southeast	Dothan	Alabama
United States	Velocity Clinical Research - Syracuse	East Syracuse	New York
United States	Texas Gastro Research, LLC	El Paso	Texas
United States	Allied Health Clinical Research Organization, LLC (AHCRO) - Englewood	Englewood	New Jersey
United States	Medisphere Medical Research Center	Evansville	Indiana
United States	Coastal Research Institute, LLC	Fayetteville	North Carolina
United States	Aa Mrc, Llc	Flint	Michigan
United States	G & L Research, LLC	Foley	Alabama
United States	Lutheran Medical Group	Fort Wayne	Indiana
United States	Allied Health Clinical Research Organization, LLC (AHCRO) - Freehold	Freehold	New Jersey
United States	Paragon Rx Clinical	Garden Grove	California
United States	Valley View Wellness and Medical Center - VVCRD	Garden Grove	California
United States	Triad Clinical Trials LLC	Greensboro	North Carolina
United States	Susquehanna Research Group, LLC	Harrisburg	Pennsylvania
United States	Peters Medical Research	High Point	North Carolina
United States	Advanced Medical Research Group	Hollywood	Florida
United States	Tandem Clinical Research GI - Houma	Houma	Louisiana
United States	Amir A Hassan, MD, PA	Houston	Texas
United States	Care and Cure Clinic	Houston	Texas
United States	Houston Methodist Research Institute	Houston	Texas
United States	Pioneer Research Solutions Inc.	Houston	Texas
United States	Clinical Research Associates, LLC	Huntsville	Alabama
United States	Nature Coast Clinical Research	Inverness	Florida
United States	Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson	Jackson	New Jersey
United States	Kansas City Research Institute	Kansas City	Missouri
United States	University of Kansas Medical Center (KUMC)	Kansas City	Kansas
United States	American Institute of Medical Research	Las Vegas	Nevada
United States	Digestive Disease Specialists	Las Vegas	Nevada
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	Preferred Research Partners, Inc.	Little Rock	Arkansas
United States	Torrance Clinical Research Institute Inc.	Lomita	California
United States	Angel City Research	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Texas Tech University Health Sciences Center	Lubbock	Texas
United States	ClinCloud LLC	Maitland	Florida
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Biopharma Informatic, LLC	McAllen	Texas
United States	Velocity Clinical Research	Medford	Oregon
United States	Tandem Clinical Research GI - Metairie	Metairie	Louisiana
United States	A+ Research Inc	Miami	Florida
United States	International Research Associates LLC - Breton	Miami	Florida
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Facey Medical Research	Mission Hills	California
United States	Montana Medical Research, Inc.	Missoula	Montana
United States	Advanced Research Institute Inc	New Port Richey	Florida
United States	Tandem Clinical Research GI- New York	New York	New York
United States	Arkansas Gastroenterology - North Little Rock	North Little Rock	Arkansas
United States	Gastroenterology of Greater Orlando	Orange City	Florida
United States	Phoenix Medical Research Institute, LLC	Peoria	Arizona
United States	Onyx Clinical Research	Phoenix	Arizona
United States	Carolina's GI Research	Raleigh	North Carolina
United States	A1 Clinical Network	Richmond Hill	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Gastroenterology Research of San Antonio	San Antonio	Texas
United States	Precision Research Institute, LLC	San Diego	California
United States	A1 Clinical Network	Spring	Texas
United States	Voyage Medical	Tempe	Arizona
United States	Millennium Clinical Trials	Thousand Oaks	California
United States	Kansas Medical Clinic, P.A.	Topeka	Kansas
United States	Clinical Research Institute of Michigan, LLC - Troy	Troy	Michigan
United States	Del Sol Research Management, LLC	Tucson	Arizona
United States	Options Health Research	Tulsa	Oklahoma
United States	Tandem Clinical Research - Viera	Viera	Florida
United States	St. Charles Clinical Research	Weldon Spring	Missouri
United States	Velocity Clinical Research - Salt Lake City	West Jordan	Utah
United States	Northshore Gastroenterology Research, LLC	Westlake	Ohio
United States	Alliance for Multispecialty Research - Wichita West	Wichita	Kansas
United States	Gastroenterology Associates of Western Michigan	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
CinDome Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Over the last 2 weeks of the 12-week Treatment Period as compared to baseline
Secondary	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
Secondary	Incidence of treatment-emergent adverse events (TEAEs)		Over the 12-week Treatment Period
Secondary	Incidence of treatment emergent Serious Adverse Events (SAEs)		Over the 12-week Treatment Period
Secondary	Incidence of TEAEs leading to premature discontinuation of study drug		Over the 12-week Treatment Period
Secondary	Incidence of treatment-emergent marked laboratory abnormalities.		Over the 12-week Treatment Period
Secondary	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
Secondary	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
Secondary	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)	Over the last 2 weeks of the 12-week Treatment Period
Secondary	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
Secondary	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	Over the last 2 weeks of the 12-week Treatment Period as compared to baseline
Secondary	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	Over the last 2 weeks of the 12-week Treatment Period as compared to baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in the PGIS with each dose of CIN-102		From baseline to Week 12
Secondary	Change in the PGIC with each dose of CIN-102		From baseline to Week 12

External Links

•   Study website