Phase
Condition
Diabetes And Hypertension
Obesity
Diabetes Mellitus, Type 2
Treatment
CT-388
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, 18 to 75 years of age
Body mass index (BMI) ≥25.0 kg/m^2
Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) according to the World HealthOrganization classification or other locally applicable standards
Have an HbA1c ≥7% and ≤10.5%
Management of T2DM with diet and exercise alone or diet and exercise and treatmentwith metformin or a sodium-glucose cotransporter-2 (SGLT-2) inhibitor as monotherapyor in combination, per approved local label
At least one self-reported unsuccessful diet/exercise effort to lose body weight
Exclusion
Exclusion Criteria:
Have Type 1 Diabetes Mellitus (T1DM), history of ketosis or hyperosmolar state/coma,or any other types of diabetes except T2DM
Have had 1 or more episodes of Level 3 hypoglycemia or have had hypoglycemiaunawareness within 3 months prior to screening
Have history or presence of proliferative diabetic retinopathy, diabetic macularedema, non-proliferative diabetic retinopathy that requires acute treatment
Have presence of active neuropathy (including resting tachycardia, orthostatichypotension, or diabetic diarrhea)
Had treatment with any oral antihyperglycemic medications, with the exception ofmetformin or SGLT-2 inhibitors, within 3 months prior to screening or plannedconcurrent treatment with these medications during the study
Had treatment with injectable antihyperglycemic medication, with the exception ofshort-term insulin, within 6 months prior to screening or planned concurrenttreatment with these medications during the study
Self-reported body weight change of >5 kg within 3 months before screening
Any unbalanced/extreme diets, such as very low calorie, low carbohydrate, very highprotein, ketogenic, or intermittent diets, within 3 months of the screening visit,or plan to be on such diets during the study
Current or recent participation in an organized weight reduction program
Current or recent use of any treatment that promotes weight loss or glucosemetabolism
Current or recent use of treatment that may cause weight gain
Prior or planned surgical treatment for obesity
Clinically significant or active gastric emptying abnormality, malabsorption, orchronic use of medications that directly affect GI motility
History of chronic pancreatitis or acute pancreatitis within 6 months beforescreening
Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) ordiagnosed monogenetic or syndromic forms of obesity
History of major depressive disorder within 2 years of screening
Family or personal history of medullary thyroid carcinoma
Women who are pregnant, breastfeeding, or intend to become pregnant, or are ofchildbearing potential and not using a highly effective contraceptive method
Study Design
Connect with a study center
Pinnacle Research Group, Llc; Central
Anniston, Alabama 36207
United StatesActive - Recruiting
University of Alabama at Birmingham (UAB)
Birmingham, Alabama 35233
United StatesActive - Recruiting
Lakeview Clinical Research, LLC
Guntersville, Alabama 35976
United StatesActive - Recruiting
AMCR Institute
Escondido, California 92025
United StatesActive - Recruiting
Catalina Research Institute, LLC
Montclair, California 91763
United StatesActive - Recruiting
Asclepes Research Centers
Sherman Oaks, California 91403
United StatesActive - Recruiting
Encompass Clinical Research
Spring Valley, California 91978
United StatesActive - Recruiting
Excel Medical Clinical Trials, LLC
Boca Raton, Florida 33434
United StatesActive - Recruiting
ASCLEPES Research Centers
Lutz, Florida 33549
United StatesActive - Recruiting
K2 Medical Research, LLC
Maitland, Florida 32751
United StatesActive - Recruiting
K2 Medical Research, LLC - Maitland
Maitland, Florida 32751
United StatesActive - Recruiting
K2 Medical Research, LLC - Orlando
Maitland, Florida 32751
United StatesActive - Recruiting
K2 Medical Research, LLC
Orlando, Florida 32751
United StatesSite Not Available
K2 Medical Research, LLC - South Orlando
Orlando, Florida 32806
United StatesActive - Recruiting
K2 Medical Research Tampa
Tampa, Florida 33607
United StatesActive - Recruiting
K2 Summit Research
The Villages, Florida 32159
United StatesActive - Recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia 30291
United StatesActive - Recruiting
Accellacare of Duly Health and Care
Lombard, Illinois 60148
United StatesActive - Recruiting
McFarland Clinic
Ames, Iowa 50010
United StatesActive - Recruiting
Cotton O'Neil Clinical Research Center
Topeka, Kansas 66606
United StatesActive - Recruiting
NOLA Cares, LLC
Metairie, Louisiana 70006
United StatesActive - Recruiting
Centennial Medical Group
Elkridge, Maryland 21075
United StatesActive - Recruiting
NECCR PrimaCare Research LLC
Fall River, Massachusetts 02721
United StatesActive - Recruiting
Ahmed Arif Medical Research Center (AA MRC LLC)
Flint, Michigan 48504
United StatesActive - Recruiting
Olive Branch Family Medical Center; Family Medicine
Olive Branch, Mississippi 38654
United StatesActive - Recruiting
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi 39157
United StatesActive - Recruiting
Ellipsis Research Group
Brooklyn, New York 11215
United StatesActive - Recruiting
Accellacare of Cary
Cary, North Carolina 27518
United StatesActive - Recruiting
Accellacare - Hickory
Hickory, North Carolina 28601
United StatesActive - Recruiting
Accellacare of Rocky Mount
Rocky Mount, North Carolina 27804
United StatesActive - Recruiting
Accellacare of Piedmont Healthcare
Statesville, North Carolina 28625
United StatesActive - Recruiting
Accellacare of Wilmington, LLC
Wilmington, North Carolina 28401
United StatesActive - Recruiting
Accellacare Research of Winston Salem
Winston Salem, North Carolina 27103
United StatesActive - Recruiting
Diabetes and Endocrinology Associates of Stark County, Inc.
Canton, Ohio 44718
United StatesActive - Recruiting
Alliance for Multispecialty Research, LLC (AMR Norman)
Norman, Oklahoma 73069
United StatesActive - Recruiting
Accellacare Charleston
Mount Pleasant, South Carolina 29464
United StatesActive - Recruiting
Roper St. Francis Physician Partners - Primary Care
Mount Pleasant, South Carolina 29464
United StatesActive - Recruiting
Internal Medicine and Pediatrics Associates of Bristol; PMG Research of Bristol
Bristol, Tennessee 37620
United StatesActive - Recruiting
Accellacare - Knoxville
Jefferson, Tennessee 37760
United StatesActive - Recruiting
Norwood Family Medicine
Knoxville, Tennessee 37912
United StatesActive - Recruiting
Summit-Halls Family Practice
Knoxville, Tennessee 37938
United StatesActive - Recruiting
Clinical Research Associates
Nashville, Tennessee 37203
United StatesActive - Recruiting
University of Texas Southwestern Medical Center Investigation Drug Services
Dallas, Texas 75390
United StatesActive - Recruiting
Velocity Clinical Research - Dallas
Dallas, Texas 75230
United StatesActive - Recruiting
Juno Research, LLC
Houston, Texas 77040
United StatesActive - Recruiting
Consano Clinical Research
Shavano Park, Texas 78231
United StatesActive - Recruiting
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