Clinical trial NCT05832151: A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetic Gastroparesis
Keywords: Gastroparesis
Diabetic gastroparesis
Gastrointestinal disease
Delayed gastric emptying
Digestive system diseases
Nausea
Vomiting
Stomach
Dopamine receptor antagonist
Lead sponsor: CinDome Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-27
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: 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
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Over the 12-week Treatment Period
measure: Incidence of treatment emergent Serious Adverse Events (SAEs)
timeFrame: Over the 12-week Treatment Period
measure: Incidence of TEAEs leading to premature discontinuation of study drug
timeFrame: Over the 12-week Treatment Period
measure: Incidence of treatment-emergent marked laboratory abnormalities.
timeFrame: Over the 12-week Treatment Period
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Change in the PGIS with each dose of CIN-102
timeFrame: From baseline to Week 12
measure: Change in the PGIC with each dose of CIN-102
timeFrame: From baseline to Week 12
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
state: Alabama
city: Foley
country: United States
facility: G & L Research, LLC
state: Alabama
city: Huntsville
country: United States
facility: Clinical Research Associates, LLC
state: Alabama
city: Peoria
country: United States
facility: Phoenix Medical Research Institute, LLC
state: Arizona
city: Phoenix
country: United States
facility: Onyx Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc.
state: Arkansas
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology - North Little Rock
state: Arkansas
city: Bell Gardens
country: United States
facility: Alliance Research Institute - Bell Gardens
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research LLC
state: California
city: Canoga Park
country: United States
facility: Alliance Research Institute, LLC
state: California
city: Chula Vista
country: United States
facility: Erick H. Alayo Medical Corporation
state: California
city: Chula Vista
country: United States
facility: GW Research Inc.
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials, LLC
state: California
city: Corona
country: United States
facility: New Hope Research Development
state: California
city: Costa Mesa
country: United States
facility: Aurora Care Clinic
state: California
city: Garden Grove
country: United States
facility: Paragon Rx Clinical
state: California
city: Garden Grove
country: United States
facility: Valley View Wellness and Medical Center - VVCRD
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute Inc.
state: California
city: Los Angeles
country: United States
facility: Angel City Research
state: California
city: Mission Hills
country: United States
facility: Facey Medical Research
state: California
city: Thousand Oaks
country: United States
facility: Millennium Clinical Trials
state: California
city: Clearwater
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Doral
country: United States
facility: USA and International Research Inc.
state: Florida
city: Hollywood
country: United States
facility: Advanced Medical Research Group
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Maitland
country: United States
facility: ClinCloud LLC
state: Florida
city: Miami
country: United States
facility: A+ Research Inc
state: Florida
city: Miami
country: United States
facility: International Research Associates LLC - Breton
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute Inc
state: Florida
city: Orange City
country: United States
facility: Gastroenterology of Greater Orlando
state: Florida
city: Viera
country: United States
facility: Tandem Clinical Research - Viera
state: Florida
city: Athens
country: United States
facility: Summit Clinical Research, LLC
state: Georgia
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology P.C.
state: Georgia
city: Evansville
country: United States
facility: Medisphere Medical Research Center
state: Indiana
city: Fort Wayne
country: United States
facility: Lutheran Medical Group
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center (KUMC)
state: Kansas
city: Overland Park
country: United States
facility: DelRicht Clinical Research - Overland Park
state: Kansas
city: Topeka
country: United States
facility: Kansas Medical Clinic, P.A.
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research - Wichita West
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Louisville
country: United States
facility: DelRicht Clinical Research - Louisville
state: Kentucky
city: Bastrop
country: United States
facility: Delta Research Partners
state: Louisiana
city: Houma
country: United States
facility: Tandem Clinical Research GI - Houma
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Metairie
country: United States
facility: Tandem Clinical Research GI - Metairie
state: Louisiana
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Flint
country: United States
facility: Aa Mrc, Llc
state: Michigan
city: Troy
country: United States
facility: Clinical Research Institute of Michigan, LLC - Troy
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Weldon Spring
country: United States
facility: St. Charles Clinical Research
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research, Inc.
state: Montana
city: Las Vegas
country: United States
facility: American Institute of Medical Research
state: Nevada
city: Las Vegas
country: United States
facility: Digestive Disease Specialists
state: Nevada
city: Englewood
country: United States
facility: Allied Health Clinical Research Organization, LLC (AHCRO) - Englewood
state: New Jersey
city: Freehold
country: United States
facility: Allied Health Clinical Research Organization, LLC (AHCRO) - Freehold
state: New Jersey
city: Jackson
country: United States
facility: Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson
state: New Jersey
city: Brooklyn
country: United States
facility: NY Scientific
state: New York
city: Brooklyn
country: United States
facility: Smart Medical Research
state: New York
city: East Syracuse
country: United States
facility: Velocity Clinical Research - Syracuse
state: New York
city: New York
country: United States
facility: Tandem Clinical Research GI- New York
state: New York
city: Richmond Hill
country: United States
facility: A1 Clinical Network
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health - Center for Digestive Health
state: North Carolina
city: Denver
country: United States
facility: Research Carolina Elite, LLC
state: North Carolina
city: Fayetteville
country: United States
facility: Coastal Research Institute, LLC
state: North Carolina
city: Fayetteville
country: United States
facility: Cross Creek Medical, PA
state: North Carolina
city: Greensboro
country: United States
facility: Triad Clinical Trials LLC
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Raleigh
country: United States
facility: Carolina's GI Research
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Remington Davis, Inc.
state: Ohio
city: Mason
country: United States
facility: DelRicht Clinical Research - Cincinnati
state: Ohio
city: Westlake
country: United States
facility: Northshore Gastroenterology Research, LLC
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research
state: Oklahoma
city: Medford
country: United States
facility: Velocity Clinical Research
state: Oregon
city: Harrisburg
country: United States
facility: Susquehanna Research Group, LLC
state: Pennsylvania
city: Chattanooga
country: United States
facility: Galen Medical Group - Downtown Gastroenterology Location
state: Tennessee
city: Chattanooga
country: United States
facility: WR ClinSearch
state: Tennessee
city: Henderson
country: United States
facility: DelRicht Clinical Research - Nashville
state: Tennessee
city: Arlington
country: United States
facility: North Hills Medical Research Inc. (North Hills Familiy Medicine)
state: Texas
city: Dallas
country: United States
facility: Zenos Clinical Research
state: Texas
city: El Paso
country: United States
facility: Texas Gastro Research, LLC
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Houston
country: United States
facility: Amir A Hassan, MD, PA
state: Texas
city: Houston
country: United States
facility: Care and Cure Clinic
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions Inc.
state: Texas
city: Lewisville
country: United States
facility: Epic Clinical Research
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: McAllen
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: McKinney
country: United States
facility: DelRicht Clinical Research - McKinney
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Research of San Antonio
state: Texas
city: Spring
country: United States
facility: A1 Clinical Network
state: Texas
city: Bountiful
country: United States
facility: HP Clinical Research (Val R. Hansen)
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research - Salt Lake City
state: Utah
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
Study officials:
References: