A Study of CT-388 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
- Registration Number
- NCT06525935
- 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 with obesity or who are overweight with at least one weight-related comorbidity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 450
- Male or female, 18 to 75 years of age
- Body mass index (BMI) ≥30.0 kg/m2, OR BMI ≥27.0 and <30.0 kg/m2 and previously diagnosed with at least 1 of the following weight-related comorbidities, such as: prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
- At least one self-reported unsuccessful effort to lose body weight
- Prior history/diagnosis/lab evidence of any type of diabetes mellitus (e.g., Type 1, Type 2, gestational), or a history of ketoacidosis or hyperosmolar state
- Self-reported body weight change of >5 kg within 3 months before randomization
- Any unbalanced/extreme 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, or any history/diagnosis of other severe psychiatric conditions (Note: Prospective participants with depression or anxiety whose disease state, in the opinion of the Investigator, is considered stable and expected to remain stable throughout the course of the study, may be considered for inclusion)
- Family or personal history of medullary thyroid carcinoma
- Serum calcitonin ≥ 20 ng/L
- 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 1: Placebo Placebo Placebo administered subcutaneously (SC) once weekly. Arm 2: CT-388 Dose Level 1 (Low) CT-388 CT-388 Dose Level 1 administered SC once weekly. Arm 3: CT-388 Dose Level 2 CT-388 CT-388 Dose Level 2 administered SC once weekly. Arm 4: CT-388 Dose Level 3 CT-388 CT-388 Dose Level 3 administered SC once weekly. Arm 5: CT-388 Dose Level 4 CT-388 CT-388 Dose Level 4 administered SC once weekly. Arm 6: CT-388 Dose Level 5 (High) CT-388 CT-388 Dose Level 5 administered SC once weekly.
- Primary Outcome Measures
Name Time Method Percent Change in Body Weight from Baseline to Week 48 Baseline to Week 48
- Secondary Outcome Measures
Name Time Method Change in Waist-to-Hip Ratio from Baseline to Week 48 Baseline to Week 48 Change in Waist-to-Height Ratio from Baseline to Week 48 Baseline to Week 48 Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 48 Baseline to Week 48 Change in Fasting Plasma Glucose from Baseline to Week 48 Baseline to Week 48 Change in Fasting Insulin from Baseline to Week 48 Baseline to Week 48 Change in Fasting C-peptide from Baseline to Week 48 Baseline to Week 48 Change in Waist Circumference from Baseline to Week 48 Baseline to Week 48 Change in Hip Circumference from Baseline to Week 48 Baseline to Week 48 Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48 Baseline and Week 48 Absolute Change in Body Weight (kg) from Baseline to Week 48 Baseline to Week 48 Percent Change in Body Weight from Baseline to Week 48 by Obesity Class Baseline to Week 48 Change in Body Mass Index (BMI) from Baseline to Week 48 Baseline to Week 48 Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Week 48 Baseline to Week 48 Change in Quantitative Insulin Sensitivity Check Index (QUICKI) from Baseline to Week 48 Baseline to Week 48 Percentage of Participants with Shift in Glycemic Status from Baseline to Week 48 Baseline and Week 48
Trial Locations
- Locations (34)
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
Central Alabama Research
🇺🇸Homewood, Alabama, United States
The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health
🇺🇸Mesa, Arizona, United States
Amicis Research Center - Anaheim
🇺🇸Anaheim, California, United States
Ark Clinical-Fountain Valley
🇺🇸Fountain Valley, California, United States
Ark Clinical Research - Long Beach
🇺🇸Long Beach, California, United States
Velocity Clinical Research - Los Angeles
🇺🇸Los Angeles, California, United States
Infinity Clinical Research
🇺🇸Norco, California, United States
Amicis Research Center
🇺🇸Northridge, California, United States
Prospective Research Innovations Inc.
🇺🇸Rancho Cucamonga, California, United States
Orange County Research Center
🇺🇸Tustin, California, United States
Amicis Research Center - West Hills
🇺🇸West Hills, California, United States
Tampa Bay Medical Research, Inc.
🇺🇸Clearwater, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
🇺🇸Louisville, Kentucky, United States
The Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Mercury Street Medical Group
🇺🇸Butte, Montana, United States
Neurobehavioral Research, Inc. (NBR)
🇺🇸Cedarhurst, New York, United States
Lucas Research, Inc
🇺🇸Morehead City, North Carolina, United States
Velocity Clinical Research - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Velocity Clinical Research, Providence
🇺🇸East Greenwich, Rhode Island, United States
Tribe Clinical Research
🇺🇸Greenville, South Carolina, United States
Alliance for Multispecialty Research, LLC
🇺🇸Knoxville, Tennessee, United States
Clinical Research Associates, Inc.
🇺🇸Nashville, Tennessee, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Austin, Texas, United States
Apex Mobile Clinical Research
🇺🇸Bellaire, Texas, United States
Velocity Clinical Research - Dallas
🇺🇸Dallas, Texas, United States
FutureSearch Trials of Dallas, LLC
🇺🇸Dallas, Texas, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Pinnacle Clinical Research
🇺🇸San Antonio, Texas, United States
Elevate Clinical
🇺🇸Seabrook, Texas, United States
Impact Research Institute
🇺🇸Waco, Texas, United States
Chrysalis Clinical Research
🇺🇸St. George, Utah, United States
National Clinical Research - Richmond, Inc
🇺🇸Richmond, Virginia, United States