A Study of CT-388 in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus

Last updated: July 28, 2025
Sponsor: Carmot Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes Mellitus, Type 2

Obesity

Diabetes And Hypertension

Treatment

Placebo

CT-388

Clinical Study ID

NCT06628362
CT-388-104
XC45544
  • Ages 18-75
  • All Genders

Study Summary

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of CT-388 at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM).

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

Total Participants: 360
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 21, 2024
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Aggarwal and Associates

    Brampton, Ontario L6T 0G1
    Canada

    Active - Recruiting

  • CEMDEC S.A. de C.V.

    Cuauhtemoc, 06100
    Mexico

    Active - Recruiting

  • Instituto de Diabetes Obesidad y Nutricion, SC

    Cuernavaca, 62250
    Mexico

    Active - Recruiting

  • SINACOR

    Culiacan, 80230
    Mexico

    Active - Recruiting

  • Medical Care and Research S.A de C.V

    Merida, 97070
    Mexico

    Active - Recruiting

  • Centro De Investigacion En Artritis Y Osteopososis

    Mexicali, 21200
    Mexico

    Active - Recruiting

  • Clinicos Asociados Bocm, S.C.

    Mexico City, 03300
    Mexico

    Active - Recruiting

  • Avant Santé Research Center

    San Pedro Garza García, 66260
    Mexico

    Active - Recruiting

  • FAICIC S de R.L. de C.V

    Veracruz, 91900
    Mexico

    Active - Recruiting

  • Sociedad de Metabolismo y Corazon S.C.

    Veracruz, 91855
    Mexico

    Active - Recruiting

  • Optimal Clinical Trials - North

    Rosedale, Auckland 0632
    New Zealand

    Active - Recruiting

  • Momentum Pukekohe

    Auckland, 2120
    New Zealand

    Active - Recruiting

  • New Zealand Clinical Research - Auckland

    Auckland, 1010
    New Zealand

    Active - Recruiting

  • New Zealand Clinical Research - Christchurch

    Christchurch, 8011
    New Zealand

    Active - Recruiting

  • Optimal Clinical Trials

    Grafton, 1010
    New Zealand

    Active - Recruiting

  • Tauranga Hospital

    Tauranga, 3110
    New Zealand

    Active - Recruiting

  • Pinnacle Research Group, Llc; Central

    Anniston, Alabama 36207
    United States

    Active - Recruiting

  • University of Alabama at Birmingham (UAB)

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Lakeview Clinical Research, LLC

    Guntersville, Alabama 35976
    United States

    Active - Recruiting

  • AMCR Institute

    Escondido, California 92025
    United States

    Active - Recruiting

  • Orange Country Research Center

    Lake Forest, California 92630
    United States

    Active - Recruiting

  • Ark Clinical Research

    Long Beach, California 90806
    United States

    Active - Recruiting

  • Catalina Research Institute, LLC

    Montclair, California 91763
    United States

    Active - Recruiting

  • Asclepes Research Centers

    Sherman Oaks, California 91403
    United States

    Active - Recruiting

  • Encompass Clinical Research

    Spring Valley, California 91978
    United States

    Active - Recruiting

  • Excel Medical Clinical Trials, LLC

    Boca Raton, Florida 33434
    United States

    Active - Recruiting

  • Flourish Research - Boca Raton

    Boca Raton, Florida 33434
    United States

    Active - Recruiting

  • Tampa Bay Medical Research

    Clearwater, Florida 33761
    United States

    Active - Recruiting

  • ASCLEPES Research Centers

    Lutz, Florida 33549
    United States

    Site Not Available

  • K2 Medical Research, LLC

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • K2 Medical Research, LLC - Maitland

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • K2 Medical Research, LLC - Orlando

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Flourish Research Acquisition, LLC

    Miami, Florida 33138
    United States

    Active - Recruiting

  • K2 Medical Research, LLC

    Orlando, Florida 32751
    United States

    Site Not Available

  • K2 Medical Research, LLC - South Orlando

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Aging Well Associates

    Saint Petersburg, Florida 33713
    United States

    Active - Recruiting

  • K2 Medical Research Tampa

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • K2 Summit Research

    The Villages, Florida 32159
    United States

    Active - Recruiting

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia 30291
    United States

    Active - Recruiting

  • Accellacare of Duly Health and Care

    Lombard, Illinois 60148
    United States

    Active - Recruiting

  • Duly Health and Care

    Lombard, Illinois 60148
    United States

    Active - Recruiting

  • McFarland Clinic

    Ames, Iowa 50010
    United States

    Active - Recruiting

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • NOLA Cares, LLC

    Metairie, Louisiana 70006
    United States

    Active - Recruiting

  • Flourish Research Acquisition, LLC dba Flourish Bowie

    Bowie, Maryland 20715
    United States

    Active - Recruiting

  • Centennial Medical Group

    Elkridge, Maryland 21075
    United States

    Active - Recruiting

  • NECCR PrimaCare Research LLC

    Fall River, Massachusetts 02721
    United States

    Active - Recruiting

  • Ahmed Arif Medical Research Center (AA MRC LLC)

    Flint, Michigan 48504
    United States

    Active - Recruiting

  • Olive Branch Family Medical Center; Family Medicine

    Olive Branch, Mississippi 38654
    United States

    Active - Recruiting

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi 39157
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Ellipsis Research Group

    Brooklyn, New York 11215
    United States

    Active - Recruiting

  • Accellacare of Cary

    Cary, North Carolina 27518
    United States

    Active - Recruiting

  • Accellacare - Hickory

    Hickory, North Carolina 28601
    United States

    Active - Recruiting

  • Accellacare of Rocky Mount

    Rocky Mount, North Carolina 27804
    United States

    Active - Recruiting

  • Accellacare of Piedmont Healthcare

    Statesville, North Carolina 28625
    United States

    Active - Recruiting

  • Accellacare of Wilmington, LLC

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • Accellacare Research of Winston Salem

    Winston Salem, North Carolina 27103
    United States

    Site Not Available

  • Accellacare Research of Winston Salem

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Diabetes and Endocrinology Associates of Stark County, Inc.

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC (AMR Norman)

    Norman, Oklahoma 73069
    United States

    Active - Recruiting

  • Accellacare Charleston

    Mount Pleasant, South Carolina 29464
    United States

    Active - Recruiting

  • Roper St. Francis Physician Partners - Primary Care

    Mount Pleasant, South Carolina 29464
    United States

    Active - Recruiting

  • Internal Medicine and Pediatrics Associates of Bristol; PMG Research of Bristol

    Bristol, Tennessee 37620
    United States

    Active - Recruiting

  • Accellacare - Knoxville

    Jefferson, Tennessee 37760
    United States

    Site Not Available

  • Norwood Family Medicine

    Knoxville, Tennessee 37912
    United States

    Active - Recruiting

  • Summit-Halls Family Practice

    Knoxville, Tennessee 37938
    United States

    Active - Recruiting

  • Clinical Research Associates

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • FutureSearch Trials of Neurology

    Austin, Texas 78731
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center Investigation Drug Services

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Velocity Clinical Research - Dallas

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Juno Research, LLC

    Houston, Texas 77040
    United States

    Active - Recruiting

  • Consano Clinical Research

    Shavano Park, Texas 78231
    United States

    Active - Recruiting

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