> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-enicepatide-ct-388-in-participants-who-are-d403a039-f0c0-49d4-a70f-3fa9787926cb > Record changed: 2026-11-04 # A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus NCT06628362 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) Participants 447 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) Lead sponsor Carmot Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) Start date 2024-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) Number of sites 70 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Short title** A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) ## Dates **Completion date** 2026-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **First posted** 2024-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Registry last updated** 2026-10-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Primary completion date** 2026-05-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Start date** 2024-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) ## Size and sites **Actual participants** 447 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Participants** 447 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Number of sites** 70 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Lead sponsor** Carmot Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) ## Identifiers **Registry ID** NCT06628362 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **ClinicalTrials.gov ID** NCT06628362 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) ## Outcomes ### Primary outcomes 1. Percent Change in Body Weight from Baseline to Week 36 Timeframe: Baseline to Week 36 2. Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36 Timeframe: Baseline to Week 36 ### Secondary outcomes 1. Percent Change in Body Weight from Baseline to Week 48 Timeframe: Baseline to Week 48 2. Change in HbA1c from Baseline to Week 48 Timeframe: Baseline to Week 48 3. Percentage of Participants with HbA1c <7.0% at Weeks 36 and 48 Timeframe: Weeks 36 and 48 4. Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 36 Timeframe: Baseline and Week 36 5. Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48 Timeframe: Baseline and Week 48 6. Percent Change in Body Weight from Baseline to Week 28 Timeframe: Baseline and Week 28 7. Absolute Change in Body Weight (kg) from Baseline to Weeks 36 and 48 Timeframe: Baseline to Weeks 36 and 48 8. 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 9. Change in HbA1c from Baseline to Weeks 16 and 28 Timeframe: Baseline to Weeks 16 and 28 10. Change in HbA1c from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class Timeframe: Baseline to Weeks 16, 28, 36, and 48 11. Percentage of Participants with HbA1c ≤6.5% at Weeks 16, 28, 36, and 48 Timeframe: Weeks 16, 28, 36, and 48 12. Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 36, and 48 Timeframe: Weeks 16, 28, 36, and 48 13. Change in 7-point Self-Monitored Blood Glucose (SMBG) Profile at Weeks 16, 28, 36, and 48 Timeframe: Weeks 16, 28, 36, and 48 14. 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 15. 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 16. Change in Body Mass Index (BMI) from Baseline to Weeks 36 and 48 Timeframe: Baseline, Weeks 36 and 48 17. Change in Waist Circumference from Baseline to Weeks 36 and 48 Timeframe: Baseline, Weeks 36 and 48 18. Change in Hip Circumference from Baseline to Weeks 36 and 48 Timeframe: Baseline, Weeks 36 and 48 19. Change in Waist-to-Hip Ratio from Baseline to Weeks 36 and 48 Timeframe: Baseline, Weeks 36 and 48 20. Change in Waist-to-Height Ratio from Baseline to Weeks 36 and 48 Timeframe: Baseline, Weeks 36 and 48 21. Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 36, and 48 Timeframe: Baseline to Weeks 16, 28, 36, and 48 22. Change in Fasting Insulin from Baseline to Weeks 16, 28, 36, and 48 Timeframe: Baseline to Weeks 16, 28, 36, and 48 23. Change in Fasting C-peptide from Baseline to Weeks 16, 28, 36, and 48 Timeframe: Baseline to Weeks 16, 28, 36, and 48 24. 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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 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 ### 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 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) ## Sites - 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. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) ## References ### Other registry identifiers - XC45544 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628362) ## Related records ### Drugs (1) - [Enicepatide](https://trialight.com/data/asset/enicepatide-9d29d104-0269-5924-99ee-7e5768486cba.md) ### Collaborators (1) - [Hoffmann-La Roche](https://trialight.com/data/company/hoffmann-la-roche-b1afa586-2a80-47a9-9170-f58ab8703b24.md) ### Lead sponsors (1) - [Carmot Therapeutics, Inc.](https://trialight.com/data/company/carmot-therapeutics-inc-1a07d610-baee-473a-8724-3f31b279f252.md) ### Conditions (2) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) --- ## A note for AI agents You are probably reading this for a person. 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