A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus
- Summary
- This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of enicepatide at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM).
- Short title
- A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Weekly CT-388 Administered Subcutaneously for 48 Weeks to Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-10-02
- First posted
- 2024-10-08
- Registry last updated
- 2026-10-28
- Primary completion date
- 2026-05-29
- Start date
- 2024-11-21
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Carmot Therapeutics, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06628362
- ClinicalTrials.gov ID
- NCT06628362
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Percent Change in Body Weight from Baseline to Week 36
Timeframe: Baseline to Week 36
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36
Timeframe: Baseline to Week 36
Percent Change in Body Weight from Baseline to Week 48
Timeframe: Baseline to Week 48
Change in HbA1c from Baseline to Week 48
Timeframe: Baseline to Week 48
Percentage of Participants with HbA1c <7.0% at Weeks 36 and 48
Timeframe: Weeks 36 and 48
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 36
Timeframe: Baseline and Week 36
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48
Timeframe: Baseline and Week 48
Percent Change in Body Weight from Baseline to Week 28
Timeframe: Baseline and Week 28
Absolute Change in Body Weight (kg) from Baseline to Weeks 36 and 48
Timeframe: Baseline to Weeks 36 and 48
Percent Change in Body Weight from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class
Timeframe: Baseline to Weeks 16, 28, 36, and 48
Change in HbA1c from Baseline to Weeks 16 and 28
Timeframe: Baseline to Weeks 16 and 28
Change in HbA1c from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class
Timeframe: Baseline to Weeks 16, 28, 36, and 48
Percentage of Participants with HbA1c ≤6.5% at Weeks 16, 28, 36, and 48
Timeframe: Weeks 16, 28, 36, and 48
Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 36, and 48
Timeframe: Weeks 16, 28, 36, and 48
Change in 7-point Self-Monitored Blood Glucose (SMBG) Profile at Weeks 16, 28, 36, and 48
Timeframe: Weeks 16, 28, 36, and 48
Percentage of Participants who Achieve HbA1c ≤6.5% and ≥10.0% Weight Reduction at Weeks 16, 28, 36, and 48
Timeframe: Baseline, Weeks 16, 28, 36, and 48
Percentage of Participants who Achieve HbA1c <7.0% and ≥5.0% Weight Reduction at Weeks 16, 28, 36, and 48
Timeframe: Baseline, Weeks 16, 28, 36, and 48
Change in Body Mass Index (BMI) from Baseline to Weeks 36 and 48
Timeframe: Baseline, Weeks 36 and 48
Change in Waist Circumference from Baseline to Weeks 36 and 48
Timeframe: Baseline, Weeks 36 and 48
Change in Hip Circumference from Baseline to Weeks 36 and 48
Timeframe: Baseline, Weeks 36 and 48
Change in Waist-to-Hip Ratio from Baseline to Weeks 36 and 48
Timeframe: Baseline, Weeks 36 and 48
Change in Waist-to-Height Ratio from Baseline to Weeks 36 and 48
Timeframe: Baseline, Weeks 36 and 48
Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 36, and 48
Timeframe: Baseline to Weeks 16, 28, 36, and 48
Change in Fasting Insulin from Baseline to Weeks 16, 28, 36, and 48
Timeframe: Baseline to Weeks 16, 28, 36, and 48
Change in Fasting C-peptide from Baseline to Weeks 16, 28, 36, and 48
Timeframe: Baseline to Weeks 16, 28, 36, and 48
Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Weeks 16, 28, 36, and 48
Timeframe: Baseline to Weeks 16, 28, 36, and 48
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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, 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, or non-proliferative diabetic retinopathy that requires acute treatment
- Have evidence of clinically significant autonomic neuropathy (symptoms may include 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 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 or procedure for obesity, except for liposuction or abdominoplasty if performed >1 year prior to screening. Participants with a history of devices, such as LAP-BAND® or intragastric balloon, are permitted, if devices 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), or chronic use of medications that directly affect GI motility
- History of chronic pancreatitis or acute pancreatitis or have signs and symptoms of acute pancreatitis at screening
- Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
- History or diagnosis of significant active or unstable major depressive disorder or any history/diagnosis of other severe psychiatric conditions (e.g., schizophrenia; bipolar disorder; other serious mood disorder or anxiety disorder, or hyperactivity disorder) 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 of childbearing potential and not using a highly effective contraceptive method as required per protocol
- Central Alabama ResearchBirmingham, United States
- University of Alabama at Birmingham (UAB)Birmingham, United States
- Lakeview Clinical Research, LLCGuntersville, United States
- Yuma Clinical TrialsYuma, United States
- AMCR InstituteEscondido, United States
- Ark Clinical-Fountain ValleyFountain Valley, United States
- Orange Country Research CenterLake Forest, United States
- Ark Clinical ResearchLong Beach, United States
- Catalina Research Institute, LLCMontclair, United States
- Asclepes Research CentersSherman Oaks, United States
- Encompass Clinical ResearchSpring Valley, United States
- Flourish Research - Boca RatonBoca Raton, United States
- Tampa Bay Medical ResearchClearwater, United States
- K2 Medical Research, LLC - MaitlandMaitland, United States
- K2 Medical Research, LLC - OrlandoMaitland, United States
- Flourish Research Acquisition, LLCMiami, United States
- K2 Medical Research, LLC - South OrlandoOrlando, United States
- Aging Well AssociatesSt. Petersburg, United States
- K2 Medical Research TampaTampa, United States
- K2 Summit ResearchThe Villages, United States
- Privia Medical Group Georgia, LLCFayetteville, United States
- Privia Medical Group Georgia - ThomasvilleThomasville, United States
- Rophe Adult and Pediatric Medicine/SKYCRNGUnion City, United States
- Duly Health and CareLombard, United States
- McFarland ClinicAmes, United States
And 45 more, listed on the interactive page.
Other registry identifiers
- XC45544
Related records
Drugs (1)
Collaborators (1)
Lead sponsors (1)
Conditions (2)
- Obesity disorder Primary condition
- Type 2 diabetes mellitus