A Study of CT-388 in Participants Who Are Overweight or Obese with Type 2 Diabetes Mellitus
- Conditions
- Overweight or ObeseType 2 Diabetes Mellitus (T2DM)
- Interventions
- Drug: CT-388Drug: Placebo
- Registration Number
- NCT06628362
- Lead Sponsor
- Carmot Therapeutics, Inc.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 360
- 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 Health Organization 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 treatment with metformin or a sodium-glucose cotransporter-2 (SGLT-2) inhibitor as monotherapy or in combination, per approved local label
- At least one self-reported unsuccessful diet/exercise effort to lose body weight
- 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 hypoglycemia unawareness within 3 months prior to screening
- Have history or presence of proliferative diabetic retinopathy, diabetic macular edema, non-proliferative diabetic retinopathy that requires acute treatment
- Have presence of active neuropathy (including resting tachycardia, orthostatic hypotension, or diabetic diarrhea)
- Had treatment with any oral antihyperglycemic medications, with the exception of metformin or SGLT-2 inhibitors, within 3 months prior to screening or planned concurrent treatment with these medications during the study
- Had treatment with injectable antihyperglycemic medication, with the exception of short-term insulin, within 6 months prior to screening or planned concurrent treatment 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 high protein, 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 glucose metabolism
- 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, or chronic use of medications that directly affect GI motility
- History of chronic pancreatitis or acute pancreatitis within 6 months before screening
- Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed 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 of childbearing potential and not using a highly effective contraceptive method
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 5: CT-388 Dose Level 4 (High) CT-388 - Arm 1: Placebo Placebo - Arm 2: CT-388 Dose Level 1 (Low) CT-388 - Arm 3: CT-388 Dose Level 2 CT-388 - Arm 4: CT-388 Dose Level 3 CT-388 -
- Primary Outcome Measures
Name Time Method Percent Change in Body Weight from Baseline to Week 48 Baseline and Week 48 Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 48 Baseline and Week 48
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48 Baseline and Week 48 Percentage of Participants with HbA1c <7.0% at Week 48 Week 48 Percent Change in Body Weight from Baseline to Week 28 Baseline and Week 28 Absolute Change in Body Weight (kg) from Baseline to Weeks 28 and 48 Baseline, Weeks 28 and 48 Percent Change in Body Weight from Baseline to Weeks 28 and 48 by Obesity Class Baseline, Weeks 28 and 48 Change in HbA1c from Baseline to Weeks 16, 28, and 40 Baseline, Weeks 16, 28, and 40 Change in HbA1c from Baseline to Weeks 16, 28, 40, and 48 by Obesity Class Baseline, Weeks 16, 28, 40, and 48 Percentage of Participants with HbA1c ≤6.5% at Weeks 16, 28, 40, and 48 Weeks 16, 28, 40, and 48 Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 40, and 48 Weeks 16, 28, 40, and 48 Change in 7-point Self-Monitored Blood Glucose (SMBG) Profile at Weeks 16, 28, and 48 Weeks 16, 28, and 48 Percentage of Participants who Achieve HbA1c ≤6.5% and ≥10.0% Weight Reduction at Weeks 28 and 48 Baseline, Weeks 28 and 48 Percentage of Participants who Achieve HbA1c <7.0% and ≥5.0% Weight Reduction at Weeks 28 and 48 Baseline, Weeks 28 and 48 Change in Body Mass Index (BMI) from Baseline to Week 48 Baseline and Week 48 Change in Waist Circumference from Baseline to Week 48 Baseline and Week 48 Change in Hip Circumference from Baseline to Week 48 Baseline and Week 48 Change in Waist-to-Hip Ratio from Baseline to Week 48 Baseline and Week 48 Change in Waist-to-Height Ratio from Baseline to Week 48 Baseline and Week 48 Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 40, and 48 Baseline, Weeks 16, 28, 40, and 48 Change in Fasting Insulin from Baseline to Weeks 16, 28, 40, and 48 Baseline, Weeks 16, 28, 40, and 48 Change in Fasting C-peptide from Baseline to Weeks 16, 28, 40, and 48 Baseline, Weeks 16, 28, 40, and 48 Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Weeks 16, 28, 40, and 48 Baseline, Weeks 16, 28, 40, and 48 Change in Quantitative Insulin Sensitivity Check Index (QUICKI) from Baseline to Weeks 16, 28, 40, and 48 Baseline, Weeks 16, 28, 40, and 48
Trial Locations
- Locations (26)
Accellacare of Piedmont Healthcare
🇺🇸Statesville, North Carolina, United States
Accellacare of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
Accellacare Research of Winston Salem
🇺🇸Winston Salem, North Carolina, United States
Diabetes and Endocrinology Associates of Stark County, Inc.
🇺🇸Canton, Ohio, United States
Alliance for Multispecialty Research, LLC (AMR Norman)
🇺🇸Norman, Oklahoma, United States
Pinnacle Research Group, Llc; Central
🇺🇸Anniston, Alabama, United States
Lakeview Clinical Research, LLC
🇺🇸Guntersville, Alabama, United States
Excel Medical Clinical Trials, LLC
🇺🇸Boca Raton, Florida, United States
ASCLEPES Research Centers
🇺🇸Lutz, Florida, United States
K2 Medical Research, LLC - Maitland
🇺🇸Maitland, Florida, United States
K2 Medical Research, LLC - Orlando
🇺🇸Maitland, Florida, United States
K2 Summit Research
🇺🇸The Villages, Florida, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
🇺🇸Union City, Georgia, United States
Accellacare of Duly Health and Care
🇺🇸Lombard, Illinois, United States
McFarland Clinic
🇺🇸Ames, Iowa, United States
NOLA Cares, LLC
🇺🇸Metairie, Louisiana, United States
Olive Branch Family Medical Center; Family Medicine
🇺🇸Olive Branch, Mississippi, United States
Accellacare of Cary
🇺🇸Cary, North Carolina, United States
Accellacare - Hickory
🇺🇸Hickory, North Carolina, United States
Accellacare of Rocky Mount
🇺🇸Rocky Mount, North Carolina, United States
Roper St. Francis Physician Partners - Primary Care
🇺🇸Mount Pleasant, South Carolina, United States
Internal Medicine and Pediatrics Associates of Bristol; PMG Research of Bristol
🇺🇸Bristol, Tennessee, United States
Accellacare - Knoxville
🇺🇸Jefferson, Tennessee, United States
Norwood Family Medicine
🇺🇸Knoxville, Tennessee, United States
Summit-Halls Family Practice
🇺🇸Knoxville, Tennessee, United States
Juno Research, LLC
🇺🇸Houston, Texas, United States