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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Overweight or Obese, Type 2 Diabetes Mellitus (T2DM)

In brief

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).

Key facts

Study ID: NCT06628362
Run by: Carmot Therapeutics, Inc.
People needed: 447
Starts: 2024-11-21
Expected to finish: 2026-09-24
Last updated by the study team: 2026-06-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States
Lakeview Clinical Research, LLC — Guntersville, Alabama, United States
Yuma Clinical Trials — Yuma, Arizona, United States
AMCR Institute — Escondido, California, United States
Ark Clinical-Fountain Valley — Fountain Valley, California, United States
Orange Country Research Center — Lake Forest, California, United States
Ark Clinical Research — Long Beach, California, United States
Catalina Research Institute, LLC — Montclair, California, United States
Asclepes Research Centers — Sherman Oaks, California, United States
Encompass Clinical Research — Spring Valley, California, United States
Flourish Research - Boca Raton — Boca Raton, Florida, United States
Tampa Bay Medical Research — Clearwater, Florida, United States
K2 Medical Research, LLC - Maitland — Maitland, Florida, United States
K2 Medical Research, LLC - Orlando — Maitland, Florida, United States
Flourish Research Acquisition, LLC — Miami, Florida, United States
K2 Medical Research, LLC - South Orlando — Orlando, Florida, United States
Aging Well Associates — St. Petersburg, Florida, United States
K2 Medical Research Tampa — Tampa, Florida, United States
K2 Summit Research — The Villages, Florida, United States
Privia Medical Group Georgia, LLC — Fayetteville, Georgia, United States
Privia Medical Group Georgia - Thomasville — Thomasville, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG — Union City, Georgia, United States
Duly Health and Care — Lombard, Illinois, United States
McFarland Clinic — Ames, Iowa, United States
Central Alabama Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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