Phase
Condition
Hypertriglyceridemia
Diabetes And Hypertension
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, metformin, or a sodium-glucosecotransporter-2 (SGLT-2) inhibitor, as monotherapy or in combination, per approvedlocal 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, or non-proliferative diabetic retinopathy that requires acute treatment
Have evidence of clinically significant autonomic neuropathy (symptoms may includeresting tachycardia, orthostatic hypotension, 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 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 or procedure for obesity, except for liposuctionor abdominoplasty if performed >1 year prior to screening. Participants with ahistory of devices, such as LAP-BAND® or intragastric balloon, are permitted, ifdevices were removed >1 year prior to screening.
History of clinically significant or active gastric emptying abnormality (e.g.,severe gastroparesis or gastric outlet obstruction, intestinal obstruction), orchronic use of medications that directly affect GI motility
History of chronic pancreatitis or acute pancreatitis or have signs and symptoms ofacute pancreatitis at screening
Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) ordiagnosed monogenetic or syndromic forms of obesity
History or diagnosis of significant active or unstable major depressive disorder orany history/diagnosis of other severe psychiatric conditions (e.g., schizophrenia;bipolar disorder; other serious mood disorder or anxiety disorder, or hyperactivitydisorder) within the last year before screening
History of any hematologic conditions that may interfere with HbA1c measurement (e.g., hemolytic anemias, sickle cell disease, other hemoglobinopathies)
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 asrequired per protocol
Study Design
Connect with a study center
Centro Medico Viamonte SRL
Buenos Aires, Provincia De Buenos 1120
ArgentinaSite Not Available
Centro Medico Viamonte SRL
Buenos Aires 3435910, Provincia de Buenos 1120
ArgentinaActive - Recruiting
Aggarwal and Associates
Brampton, Ontario L6T 0G1
CanadaActive - Recruiting
Centricity Research Brampton Endocrinology
Brampton, Ontario L6S 0C6
CanadaSite Not Available
Centricity Research Oshawa Multispecialty
Oshawa, Ontario L1J 2K9
CanadaSite Not Available
LMC Clinical Research Inc
Toronto, Ontario M4G 3E8
CanadaSite Not Available
Aggarwal and Associates
Brampton 5907364, Ontario 6093943 L6T 0G1
CanadaActive - Recruiting
Centricity Research Brampton Endocrinology
Brampton 5907364, Ontario 6093943 L6S 0C6
CanadaActive - Recruiting
Centricity Research Oshawa Multispecialty
Oshawa 6094578, Ontario 6093943 L1J 2K9
CanadaActive - Recruiting
LMC Clinical Research Inc
Toronto 6167865, Ontario 6093943 M4G 3E8
CanadaActive - Recruiting
CEMDEC S.A. de C.V.
Cuauhtemoc, 06100
MexicoSite Not Available
CEMDEC S.A. de C.V.
Cuauhtémoc 3827409, 06100
MexicoActive - Recruiting
Instituto de Diabetes Obesidad y Nutricion, SC
Cuernavaca, 62250
MexicoSite Not Available
Instituto de Diabetes Obesidad y Nutricion, SC
Cuernavaca 3529947, 62250
MexicoActive - Recruiting
SINACOR
Culiacan, 80230
MexicoSite Not Available
SINACOR
Culiacán 4012176, 80230
MexicoActive - Recruiting
Medical Care and Research S.A de C.V
Merida, 97070
MexicoSite Not Available
Centro De Investigacion En Artritis Y Osteopososis
Mexicali, 21200
MexicoSite Not Available
Centro De Investigacion En Artritis Y Osteopososis
Mexicali 3996069, 21200
MexicoActive - Recruiting
Clinicos Asociados Bocm, S.C.
Mexico City, 03300
MexicoSite Not Available
Clinicos Asociados Bocm, S.C.
Mexico City 3530597, 03300
MexicoActive - Recruiting
Medical Care and Research S.A de C.V
Mérida 3523349, 97070
MexicoActive - Recruiting
Avant Santé Research Center
San Pedro Garza García, 66260
MexicoSite Not Available
Avant Santé Research Center
San Pedro Garza García 4005937, 66260
MexicoActive - Recruiting
FAICIC S de R.L. de C.V
Veracruz, 91900
MexicoSite Not Available
Sociedad de Metabolismo y Corazon S.C.
Veracruz, 91855
MexicoActive - Recruiting
FAICIC S de R.L. de C.V
Veracruz 3514783, 91900
MexicoActive - Recruiting
Sociedad de Metabolismo y Corazon S.C.
Veracruz 3514783, 91855
MexicoActive - Recruiting
Optimal Clinical Trials - North
Rosedale, Auckland 2193734 0632
New ZealandActive - Recruiting
Momentum Pukekohe
Auckland, 2120
New ZealandSite Not Available
New Zealand Clinical Research - Auckland
Auckland, 1010
New ZealandActive - Recruiting
Momentum Pukekohe
Auckland 2193733, 2120
New ZealandActive - Recruiting
New Zealand Clinical Research - Auckland
Auckland 2193733, 1010
New ZealandActive - Recruiting
New Zealand Clinical Research - Christchurch
Christchurch, 8011
New ZealandSite Not Available
New Zealand Clinical Research - Christchurch
Christchurch 2192362, 8011
New ZealandActive - Recruiting
Optimal Clinical Trials
Grafton, 1010
New ZealandSite Not Available
Optimal Clinical Trials
Grafton 6232401, 1010
New ZealandActive - Recruiting
Tauranga Hospital
Tauranga, 3110
New ZealandSite Not Available
Tauranga Hospital
Tauranga 2208032, 3110
New ZealandActive - Recruiting
Momentum Wellington
Wellington, 6021
New ZealandSite Not Available
Momentum Wellington
Wellington 2179537, 6021
New ZealandActive - Recruiting
ISIS Clinical Research Center
Guaynabo, 00970
Puerto RicoSite Not Available
ISIS Clinical Research Center
Guaynabo 4565119, 00970
Puerto RicoActive - Recruiting
Pinnacle Research Group, Llc; Central
Anniston, Alabama 36207
United StatesSite Not Available
Alabama Clinical Therapeutics
Birmingham, Alabama 35235
United StatesActive - Recruiting
Central Alabama Research
Birmingham, Alabama 35209-8401
United StatesSite Not Available
University of Alabama at Birmingham (UAB)
Birmingham, Alabama 35233
United StatesActive - Recruiting
Lakeview Clinical Research, LLC
Guntersville, Alabama 35976
United StatesSite Not Available
Pinnacle Research Group, Llc; Central
Anniston 4830198, Alabama 4829764 36207
United StatesActive - Recruiting
Alabama Clinical Therapeutics
Birmingham 4049979, Alabama 4829764 35235
United StatesActive - Recruiting
Central Alabama Research
Birmingham 4049979, Alabama 4829764 35209-8401
United StatesActive - Recruiting
University of Alabama at Birmingham (UAB)
Birmingham 4049979, Alabama 4829764 35233
United StatesActive - Recruiting
Lakeview Clinical Research, LLC
Guntersville 4065649, Alabama 4829764 35976
United StatesActive - Recruiting
Synexus - Clinical Research Advantage - Central Phoenix Medical Clinic LLC
Phoenix, Arizona 85020
United StatesSite Not Available
Yuma Clinical Trials
Yuma, Arizona 85364
United StatesSite Not Available
Synexus - Clinical Research Advantage - Central Phoenix Medical Clinic LLC
Phoenix 5308655, Arizona 5551752 85020
United StatesActive - Recruiting
Yuma Clinical Trials
Yuma 5322053, Arizona 5551752 85364
United StatesActive - Recruiting
AMCR Institute
Escondido, California 92025
United StatesSite Not Available
Orange Country Research Center
Lake Forest, California 92630
United StatesSite Not Available
Ark Clinical Research
Long Beach, California 90806
United StatesSite Not Available
Catalina Research Institute, LLC
Montclair, California 91763
United StatesSite Not Available
Asclepes Research Centers
Sherman Oaks, California 91403
United StatesSite Not Available
Encompass Clinical Research
Spring Valley, California 91978
United StatesSite Not Available
AMCR Institute
Escondido 5346827, California 5332921 92025
United StatesActive - Recruiting
Ark Clinical-Fountain Valley
Fountain Valley 5350207, California 5332921 92708
United StatesActive - Recruiting
Orange Country Research Center
Lake Forest 5364514, California 5332921 92630
United StatesActive - Recruiting
Ark Clinical Research
Long Beach 5367929, California 5332921 90806
United StatesActive - Recruiting
Catalina Research Institute, LLC
Montclair 5374232, California 5332921 91763
United StatesActive - Recruiting
Asclepes Research Centers
Sherman Oaks 5395244, California 5332921 91403
United StatesActive - Recruiting
Encompass Clinical Research
Spring Valley 5398277, California 5332921 91978
United StatesActive - Recruiting
Excel Medical Clinical Trials, LLC
Boca Raton, Florida 33434
United StatesActive - Recruiting
Flourish Research - Boca Raton
Boca Raton, Florida 33434
United StatesSite Not Available
Tampa Bay Medical Research
Clearwater, Florida 33761
United StatesSite Not Available
ASCLEPES Research Centers
Lutz, Florida 33549
United StatesSite Not Available
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 StatesSite Not Available
Flourish Research Acquisition, LLC
Miami, Florida 33138
United StatesSite Not Available
K2 Medical Research, LLC
Orlando, Florida 32751
United StatesSite Not Available
K2 Medical Research, LLC - South Orlando
Orlando, Florida 32806
United StatesSite Not Available
Aging Well Associates
Saint Petersburg, Florida 33713
United StatesSite Not Available
K2 Medical Research Tampa
Tampa, Florida 33607
United StatesSite Not Available
K2 Summit Research
The Villages, Florida 32159
United StatesSite Not Available
Flourish Research - Boca Raton
Boca Raton 4148411, Florida 4155751 33434
United StatesActive - Recruiting
Tampa Bay Medical Research
Clearwater 4151316, Florida 4155751 33761
United StatesActive - Recruiting
ASCLEPES Research Centers
Lutz 4163033, Florida 4155751 33549
United StatesSite Not Available
K2 Medical Research, LLC - Maitland
Maitland 4163220, Florida 4155751 32751
United StatesActive - Recruiting
K2 Medical Research, LLC - Orlando
Maitland 4163220, Florida 4155751 32751
United StatesActive - Recruiting
Flourish Research Acquisition, LLC
Miami 4164138, Florida 4155751 33138
United StatesActive - Recruiting
K2 Medical Research, LLC - South Orlando
Orlando 4167147, Florida 4155751 32806
United StatesActive - Recruiting
Aging Well Associates
St. Petersburg 4171563, Florida 4155751 33713
United StatesActive - Recruiting
K2 Medical Research Tampa
Tampa 4174757, Florida 4155751 33607
United StatesActive - Recruiting
K2 Summit Research
The Villages 4175179, Florida 4155751 32159
United StatesActive - Recruiting
Privia Medical Group Georgia, LLC
Fayetteville, Georgia 30214
United StatesSite Not Available
Javara Inc. /Privia Medical Group Georgia, LLC
Richmond Hill, Georgia 31324
United StatesSite Not Available
Privia Medical Group Georgia - Thomasville
Thomasville, Georgia 31792
United StatesSite Not Available
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia 30291
United StatesSite Not Available
Privia Medical Group Georgia, LLC
Fayetteville 4194474, Georgia 4197000 30214
United StatesActive - Recruiting
Javara Inc. /Privia Medical Group Georgia, LLC
Richmond Hill 4218752, Georgia 4197000 31324
United StatesActive - Recruiting
Privia Medical Group Georgia - Thomasville
Thomasville 4226348, Georgia 4197000 31792
United StatesActive - Recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City 4227777, Georgia 4197000 30291
United StatesActive - Recruiting
Accellacare of Duly Health and Care
Lombard, Illinois 60148
United StatesActive - Recruiting
Duly Health and Care
Lombard, Illinois 60148
United StatesSite Not Available
Duly Health and Care
Lombard 4900373, Illinois 4896861 60148
United StatesActive - Recruiting
McFarland Clinic
Ames, Iowa 50010
United StatesSite Not Available
McFarland Clinic
Ames 4846834, Iowa 4862182 50010
United StatesActive - Recruiting
Cotton O'Neil Clinical Research Center
Topeka, Kansas 66606
United StatesSite Not Available
Cotton O'Neil Clinical Research Center
Topeka 4280539, Kansas 4273857 66606
United StatesActive - Recruiting
NOLA Cares, LLC
Metairie, Louisiana 70006
United StatesSite Not Available
NOLA Cares, LLC
Metairie 4333177, Louisiana 4331987 70006
United StatesActive - Recruiting
Flourish Research Acquisition, LLC dba Flourish Bowie
Bowie, Maryland 20715
United StatesSite Not Available
Centennial Medical Group
Elkridge, Maryland 21075
United StatesSite Not Available
Flourish Research Acquisition, LLC dba Flourish Bowie
Bowie 4349159, Maryland 4361885 20715
United StatesActive - Recruiting
Centennial Medical Group
Elkridge 4354256, Maryland 4361885 21075
United StatesActive - Recruiting
NECCR PrimaCare Research LLC
Fall River, Massachusetts 02721
United StatesSite Not Available
NECCR PrimaCare Research LLC
Fall River 4936159, Massachusetts 6254926 02721
United StatesActive - Recruiting
Ahmed Arif Medical Research Center (AA MRC LLC)
Flint, Michigan 48504
United StatesSite Not Available
Ahmed Arif Medical Research Center (AA MRC LLC)
Flint 4992982, Michigan 5001836 48504
United StatesActive - Recruiting
Prime Health and Wellness
Fayette, Mississippi 39069
United StatesSite Not Available
Olive Branch Family Medical Center; Family Medicine
Olive Branch, Mississippi 38654
United StatesSite Not Available
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi 39157
United StatesSite Not Available
Prime Health and Wellness
Fayette 4426218, Mississippi 4436296 39069
United StatesActive - Recruiting
Olive Branch Family Medical Center; Family Medicine
Olive Branch 4439869, Mississippi 4436296 38654
United StatesActive - Recruiting
SKY Integrative Medical Center/SKYCRNG
Ridgeland 4443296, Mississippi 4436296 39157
United StatesActive - Recruiting
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198
United StatesActive - Recruiting
Ellipsis Research Group
Brooklyn, New York 11215
United StatesSite Not Available
Ellipsis Research Group
Brooklyn 5110302, New York 5128638 11215
United StatesActive - Recruiting
Accellacare of Cary
Cary, North Carolina 27518
United StatesSite Not Available
Accellacare - Hickory
Hickory, North Carolina 28601
United StatesSite Not Available
Accellacare of Rocky Mount
Rocky Mount, North Carolina 27804
United StatesSite Not Available
Accellacare of Piedmont Healthcare
Statesville, North Carolina 28625
United StatesSite Not Available
Accellacare of Wilmington, LLC
Wilmington, North Carolina 28401
United StatesSite Not Available
Accellacare Research of Winston Salem
Winston Salem, North Carolina 27103
United StatesSite Not Available
Accellacare Research of Winston Salem
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Accellacare of Cary
Cary 4459467, North Carolina 4482348 27518
United StatesActive - Recruiting
Accellacare - Hickory
Hickory 4470778, North Carolina 4482348 28601
United StatesActive - Recruiting
Accellacare of Rocky Mount
Rocky Mount 4488762, North Carolina 4482348 27804
United StatesActive - Recruiting
Accellacare of Piedmont Healthcare
Statesville 4493316, North Carolina 4482348 28625
United StatesActive - Recruiting
Accellacare of Wilmington, LLC
Wilmington 4499379, North Carolina 4482348 28401
United StatesActive - Recruiting
Accellacare Research of Winston Salem
Winston-Salem 4499612, North Carolina 4482348 27103
United StatesActive - Recruiting
Diabetes and Endocrinology Associates of Stark County, Inc.
Canton, Ohio 44718
United StatesSite Not Available
Diabetes and Endocrinology Associates of Stark County, Inc.
Canton 5149222, Ohio 5165418 44718
United StatesActive - Recruiting
Tekton Research
Edmond, Oklahoma 73013
United StatesSite Not Available
Alliance for Multispecialty Research, LLC (AMR Norman)
Norman, Oklahoma 73069
United StatesSite Not Available
Tekton Research
Edmond 4535740, Oklahoma 4544379 73013
United StatesActive - Recruiting
Alliance for Multispecialty Research, LLC (AMR Norman)
Norman 4543762, Oklahoma 4544379 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 StatesSite Not Available
Roper St. Francis Physician Partners - Primary Care
Mt. Pleasant 4588165, South Carolina 4597040 29464
United StatesActive - Recruiting
Internal Medicine and Pediatrics Associates of Bristol; PMG Research of Bristol
Bristol, Tennessee 37620
United StatesSite Not Available
Accellacare - Knoxville
Jefferson, Tennessee 37760
United StatesSite Not Available
Norwood Family Medicine
Knoxville, Tennessee 37912
United StatesSite Not Available
Summit-Halls Family Practice
Knoxville, Tennessee 37938
United StatesActive - Recruiting
Clinical Research Associates
Nashville, Tennessee 37203
United StatesSite Not Available
Internal Medicine and Pediatrics Associates of Bristol; PMG Research of Bristol
Bristol 4608657, Tennessee 4662168 37620
United StatesActive - Recruiting
Accellacare - Knoxville
Jefferson 4632927, Tennessee 4662168 37760
United StatesSite Not Available
Norwood Family Medicine
Knoxville 4634946, Tennessee 4662168 37912
United StatesActive - Recruiting
Summit-Halls Family Practice
Knoxville 4634946, Tennessee 4662168 37938
United StatesActive - Recruiting
Clinical Research Associates
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
FutureSearch Trials of Neurology
Austin, Texas 78731
United StatesSite Not Available
University of Texas Southwestern Medical Center Investigation Drug Services
Dallas, Texas 75390
United StatesSite Not Available
Velocity Clinical Research - Dallas
Dallas, Texas 75230
United StatesActive - Recruiting
Juno Research, LLC
Houston, Texas 77040
United StatesSite Not Available
Consano Clinical Research
Shavano Park, Texas 78231
United StatesSite Not Available
Privia Medical Group North Texas - Stephenville
Stephenville, Texas 76401
United StatesSite Not Available
FutureSearch Trials of Neurology
Austin 4671654, Texas 4736286 78731
United StatesActive - Recruiting
University of Texas Southwestern Medical Center Investigation Drug Services
Dallas 4684888, Texas 4736286 75390
United StatesActive - Recruiting
Velocity Clinical Research - Dallas
Dallas 4684888, Texas 4736286 75230
United StatesActive - Recruiting
Juno Research, LLC
Houston 4699066, Texas 4736286 77040
United StatesActive - Recruiting
Consano Clinical Research
Shavano Park 4728147, Texas 4736286 78231
United StatesActive - Recruiting
Privia Medical Group North Texas - Stephenville
Stephenville 4734350, Texas 4736286 76401
United StatesActive - Recruiting
Manassas Clinical Research Center
Manassas, Virginia 20110
United StatesSite Not Available
Manassas Clinical Research Center
Manassas 4771401, Virginia 6254928 20110
United StatesActive - Recruiting
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