Phase
Condition
Diabetic Gastroparesis
Gastroparesis
Treatment
CIN-102 Dose 1
CIN-102 Dose 1 or 2
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 DiabetesAssociation criteria;
Has a current diagnosis of diabetic gastroparesis defined by the following:
Persistent gastrointestinal symptoms that in the opinion of the Investigatorare consistent with gastroparesis within 6 months prior to Screening; AND
Documented delayed gastric emptying as determined by gastric emptying breathtest (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 thefollowing criteria are satisfied:
The GLP-1 RA has been prescribed for the management of diabetes and notspecifically for weight loss/weight management;
Has been on a stable dose of GLP-1RA for a minimum of 3 months before Screeningand is anticipated to sustain the same dose during GEBT and throughout thestudy;
Is tolerating the GLP-1RA well based on Investigator's judgment;
None of the study-qualifying signs/symptoms of gastroparesis are solelyattributable to the use of GLP-1RA; and
The symptoms of gastroparesis preceded the initiation of GLP-1RA therapy.
- Willing to washout from ongoing treatment for gastroparesis.
Exclusion
Key Exclusion Criteria:
Has known cause of gastroparesis other than diabetes (eg, idiopathic gastroparesisand/or gastroparesis attributed to surgery, viral illness, cancer, scleroderma, orother neurologic disorder);
Has been hospitalized within 3 months prior to Visit 1 for diabetic gastroparesisand/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 enteraltube 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 orbreastfeed during the study.
Study Design
Connect with a study center
Digestive Health Specialists of the Southeast
Dothan, Alabama 36305
United StatesCompleted
G & L Research, LLC
Foley, Alabama 36535
United StatesActive - Recruiting
Clinical Research Associates, LLC
Huntsville, Alabama 35801
United StatesActive - Recruiting
Phoenix Medical Research Institute, LLC
Peoria, Arizona 85381
United StatesCompleted
Onyx Clinical Research
Phoenix, Arizona 85381
United StatesActive - Recruiting
Voyage Medical
Tempe, Arizona 85282
United StatesSite Not Available
Adobe Clinical Research, LLC
Tucson, Arizona 85712
United StatesActive - Recruiting
Del Sol Research Management, LLC
Tucson, Arizona 85715
United StatesActive - Recruiting
Applied Research Center of Arkansas
Little Rock, Arkansas 72212
United StatesActive - Recruiting
Preferred Research Partners, Inc.
Little Rock, Arkansas 72211
United StatesCompleted
Arkansas Gastroenterology - North Little Rock
North Little Rock, Arkansas 72117
United StatesCompleted
Alliance Research Institute - Bell Gardens
Bell Gardens, California 90201
United StatesActive - Recruiting
Alliance Research Institute, LLC
Canoga Park, California 91304
United StatesActive - Recruiting
Hope Clinical Research LLC
Canoga Park, California 91303
United StatesActive - Recruiting
Erick H. Alayo Medical Corporation
Chula Vista, California 91910
United StatesActive - Recruiting
GW Research Inc.
Chula Vista, California 91910
United StatesCompleted
Kindred Medical Institute for Clinical Trials, LLC
Corona, California 92879
United StatesActive - Recruiting
New Hope Research Development
Corona, California 92882
United StatesActive - Recruiting
Aurora Care Clinic
Costa Mesa, California 92627
United StatesActive - Recruiting
Paragon Rx Clinical
Garden Grove, California 92840
United StatesActive - Recruiting
Valley View Wellness and Medical Center - VVCRD
Garden Grove, California 92845
United StatesActive - Recruiting
Torrance Clinical Research Institute Inc.
Lomita, California 09717
United StatesActive - Recruiting
Angel City Research
Los Angeles, California 90010
United StatesActive - Recruiting
Facey Medical Research
Mission Hills, California 11333
United StatesCompleted
Precision Research Institute, LLC
San Diego, California 92114
United StatesSite Not Available
Millennium Clinical Trials
Thousand Oaks, California 91360
United StatesActive - Recruiting
Innovative Research of West Florida
Clearwater, Florida 33756
United StatesActive - Recruiting
USA and International Research Inc.
Doral, Florida 33126
United StatesActive - Recruiting
Advanced Medical Research Group
Hollywood, Florida 33021
United StatesActive - Recruiting
Nature Coast Clinical Research
Inverness, Florida 34452
United StatesActive - Recruiting
ClinCloud LLC
Maitland, Florida 32751
United StatesActive - Recruiting
A+ Research Inc
Miami, Florida 33144
United StatesActive - Recruiting
International Research Associates LLC - Breton
Miami, Florida 33183
United StatesActive - Recruiting
Advanced Research Institute Inc
New Port Richey, Florida 34653
United StatesActive - Recruiting
Gastroenterology of Greater Orlando
Orange City, Florida 32763
United StatesCompleted
Tandem Clinical Research - Viera
Viera, Florida 32940
United StatesActive - Recruiting
Summit Clinical Research, LLC
Athens, Georgia 30607
United StatesCompleted
Atlanta Center for Gastroenterology P.C.
Decatur, Georgia 30033
United StatesCompleted
Medisphere Medical Research Center
Evansville, Indiana 47714
United StatesCompleted
Lutheran Medical Group
Fort Wayne, Indiana 46804
United StatesCompleted
University of Kansas Medical Center (KUMC)
Kansas City, Kansas 66160
United StatesActive - Recruiting
Kansas Medical Clinic, P.A.
Topeka, Kansas 66606
United StatesActive - Recruiting
Alliance for Multispecialty Research - Wichita West
Wichita, Kansas 67205
United StatesCompleted
University of Louisville
Louisville, Kentucky 40202
United StatesCompleted
Delta Research Partners
Bastrop, Louisiana 71201
United StatesActive - Recruiting
Tandem Clinical Research GI - Houma
Houma, Louisiana 70363
United StatesCompleted
Tandem Clinical Research
Marrero, Louisiana 70072
United StatesCompleted
Tandem Clinical Research GI - Metairie
Metairie, Louisiana 70006
United StatesActive - Recruiting
Delta Research Partners
Monroe, Louisiana 71201
United StatesSite Not Available
Voyage Medical Services, PLLC- Canton, Mighica
Canton, Michigan 85282
United StatesSite Not Available
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan 48047
United StatesActive - Recruiting
Aa Mrc, Llc
Flint, Michigan 48504
United StatesActive - Recruiting
Clinical Research Institute of Michigan, LLC - Troy
Troy, Michigan 48098
United StatesCompleted
Gastroenterology Associates of Western Michigan
Wyoming, Michigan 49519
United StatesActive - Recruiting
Kansas City Research Institute
Kansas City, Missouri 64131
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesCompleted
St. Charles Clinical Research
Weldon Spring, Missouri 63304
United StatesActive - Recruiting
Montana Medical Research, Inc.
Missoula, Montana 59808
United StatesCompleted
American Institute of Medical Research
Las Vegas, Nevada 89123
United StatesActive - Recruiting
Digestive Disease Specialists
Las Vegas, Nevada 89128
United StatesCompleted
Allied Health Clinical Research Organization, LLC (AHCRO) - Englewood
Englewood, New Jersey 07631
United StatesCompleted
Allied Health Clinical Research Organization, LLC (AHCRO) - Freehold
Freehold, New Jersey 07728
United StatesCompleted
Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson
Jackson, New Jersey 08527
United StatesCompleted
NY Scientific
Brooklyn, New York 11235
United StatesActive - Recruiting
Smart Medical Research
Brooklyn, New York 11372
United StatesCompleted
Velocity Clinical Research - Syracuse
East Syracuse, New York 13057
United StatesActive - Recruiting
Long Island Gastrointestinal Research Group
Great Neck, New York 11023
United StatesSite Not Available
Smart Medical Research
Jackson Heights, New York 11372
United StatesSite Not Available
Tandem Clinical Research GI- New York
New York, New York 10033
United StatesActive - Recruiting
A1 Clinical Network
Richmond Hill, New York 11418
United StatesCompleted
Atrium Health - Center for Digestive Health
Charlotte, North Carolina 28204
United StatesActive - Recruiting
OnSite Clinical Solutions, LLC
Charlotte, North Carolina 28144
United StatesCompleted
Research Carolina Elite, LLC
Denver, North Carolina 28037
United StatesCompleted
Coastal Research Institute, LLC
Fayetteville, North Carolina 28304
United StatesActive - Recruiting
Triad Clinical Trials LLC
Greensboro, North Carolina 27410
United StatesCompleted
Peters Medical Research
High Point, North Carolina 27260
United StatesActive - Recruiting
Carolina's GI Research
Raleigh, North Carolina 27612
United StatesCompleted
OnSite Clinical Solutions, LLC
Salisbury, North Carolina 28144
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesCompleted
Remington Davis, Inc.
Columbus, Ohio 43215
United StatesActive - Recruiting
Northshore Gastroenterology Research, LLC
Westlake, Ohio 44145
United StatesActive - Recruiting
Options Health Research
Tulsa, Oklahoma 74104
United StatesActive - Recruiting
Velocity Clinical Research
Medford, Oregon 97504
United StatesCompleted
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania 17110
United StatesActive - Recruiting
Galen Medical Group - Downtown Gastroenterology Location
Chattanooga, Tennessee 37343
United StatesActive - Recruiting
WR ClinSearch
Chattanooga, Tennessee 37421
United StatesCompleted
Galen Medical Group - Downtown Gastroenterology Location
Hixson, Tennessee 37343
United StatesSite Not Available
North Hills Medical Research Inc. (North Hills Familiy Medicine)
Arlington, Texas 76012
United StatesActive - Recruiting
Zenos Clinical Research
Dallas, Texas 75230
United StatesActive - Recruiting
Texas Gastro Research, LLC
El Paso, Texas 10908
United StatesCompleted
Texas Tech University Health Sciences Center
El Paso, Texas 79905
United StatesActive - Recruiting
Amir A Hassan, MD, PA
Houston, Texas 77089
United StatesActive - Recruiting
Care and Cure Clinic
Houston, Texas 77090
United StatesCompleted
Houston Methodist Research Institute
Houston, Texas 77030
United StatesCompleted
Pioneer Research Solutions Inc.
Houston, Texas 77099
United StatesActive - Recruiting
Texas Tech University Health Sciences Center
Lubbock, Texas 79905
United StatesActive - Recruiting
Biopharma Informatic, LLC
McAllen, Texas 78503
United StatesCompleted
Gastroenterology Research of San Antonio
San Antonio, Texas 78229
United StatesCompleted
A1 Clinical Network
Spring, Texas 77386
United StatesCompleted
HP Clinical Research (Val R. Hansen)
Bountiful, Utah 84010
United StatesCompleted
Velocity Clinical Research - Salt Lake City
Riverton, Utah 84065
United StatesSite Not Available
Velocity Clinical Research - Salt Lake City
West Jordan, Utah 84065
United StatesCompleted
Manassas Clinical Research Center
Manassas, Virginia 20110
United StatesActive - Recruiting
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin 53215
United StatesCompleted
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