A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis
Purpose
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
Condition
- Diabetic Gastroparesis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CIN-102: Dose 15mg or 10mg |
CIN-102, Dose 15 mg or 10 mg, twice daily for 12 weeks |
|
|
Placebo Comparator Placebo |
Placebo for CIN-102, twice daily for 12 weeks |
|
Recruiting Locations
G & L Research, LLC
Foley, Alabama 36535
Foley, Alabama 36535
Clinical Research Associates, LLC
Huntsville, Alabama 35801
Huntsville, Alabama 35801
Onyx Clinical Research
Phoenix, Arizona 85381
Phoenix, Arizona 85381
Del Sol Research Management, LLC
Tucson, Arizona 85715
Tucson, Arizona 85715
Applied Research Center of Arkansas
Little Rock, Arkansas 72212
Little Rock, Arkansas 72212
Alliance Research Institute - Bell Gardens
Bell Gardens, California 90201
Bell Gardens, California 90201
Hope Clinical Research LLC
Canoga Park, California 91303
Canoga Park, California 91303
Alliance Research Institute, LLC
Canoga Park, California 91304
Canoga Park, California 91304
Erick H. Alayo Medical Corporation
Chula Vista, California 91910
Chula Vista, California 91910
Kindred Medical Institute for Clinical Trials, LLC
Corona, California 92879
Corona, California 92879
New Hope Research Development
Corona, California 92882
Corona, California 92882
Paragon Rx Clinical
Garden Grove, California 92840
Garden Grove, California 92840
Valley View Wellness and Medical Center - VVCRD
Garden Grove, California 92845
Garden Grove, California 92845
Torrance Clinical Research Institute Inc.
Lomita, California 09717
Lomita, California 09717
Angel City Research
Los Angeles, California 90010
Los Angeles, California 90010
Millennium Clinical Trials
Thousand Oaks, California 91360
Thousand Oaks, California 91360
Innovative Research of West Florida
Clearwater, Florida 33756
Clearwater, Florida 33756
USA and International Research Inc.
Doral, Florida 33126
Doral, Florida 33126
Advanced Medical Research Group
Hollywood, Florida 33021
Hollywood, Florida 33021
Nature Coast Clinical Research
Inverness, Florida 34452
Inverness, Florida 34452
International Research Associates LLC - Breton
Miami, Florida 33183
Miami, Florida 33183
Advanced Research Institute Inc
New Port Richey, Florida 34653
New Port Richey, Florida 34653
Tandem Clinical Research - Viera
Viera, Florida 32940
Viera, Florida 32940
University of Kansas Medical Center (KUMC)
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Kansas Medical Clinic, P.A.
Topeka, Kansas 66606
Topeka, Kansas 66606
Delta Research Partners
Bastrop, Louisiana 71201
Bastrop, Louisiana 71201
Tandem Clinical Research GI - Metairie
Metairie, Louisiana 70006
Metairie, Louisiana 70006
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan 48047
Chesterfield, Michigan 48047
Gastroenterology Associates of Western Michigan
Wyoming, Michigan 49519
Wyoming, Michigan 49519
Kansas City Research Institute
Kansas City, Missouri 64131
Kansas City, Missouri 64131
St. Charles Clinical Research
Weldon Spring, Missouri 63304
Weldon Spring, Missouri 63304
American Institute of Medical Research
Las Vegas, Nevada 89123
Las Vegas, Nevada 89123
Velocity Clinical Research - Syracuse
East Syracuse, New York 13057
East Syracuse, New York 13057
Tandem Clinical Research GI- New York
New York, New York 10033
New York, New York 10033
Atrium Health - Center for Digestive Health
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
Coastal Research Institute, LLC
Fayetteville, North Carolina 28304
Fayetteville, North Carolina 28304
Peters Medical Research
High Point, North Carolina 27260
High Point, North Carolina 27260
Northshore Gastroenterology Research, LLC
Westlake, Ohio 44145
Westlake, Ohio 44145
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania 17110
Harrisburg, Pennsylvania 17110
Galen Medical Group - Downtown Gastroenterology Location
Chattanooga, Tennessee 37343
Chattanooga, Tennessee 37343
North Hills Medical Research Inc. (North Hills Familiy Medicine)
Arlington, Texas 76012
Arlington, Texas 76012
Zenos Clinical Research
Dallas, Texas 75230
Dallas, Texas 75230
Pioneer Research Solutions Inc.
Houston, Texas 77099
Houston, Texas 77099
Texas Tech University Health Sciences Center
Lubbock, Texas 79905
Lubbock, Texas 79905
Manassas Clinical Research Center
Manassas, Virginia 20110
Manassas, Virginia 20110
More Details
- NCT ID
- NCT05832151
- Status
- Recruiting
- Sponsor
- CinDome Pharma, Inc.