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Clinical Trials in the USA / NCT06628362
Active, not recruiting Phase 2

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

NCT06628362 · tracked via the Priya Life Science USA tracker
Sponsor
Carmot Therapeutics, Inc.
Phase
Phase 2
Started
2024-11-21
Last updated
2026-06-24

Condition(s) studied

Overweight or ObeseType 2 Diabetes Mellitus (T2DM)

Investigational drug(s) / intervention(s)

PlaceboEnicepatide

Placebo: Placebo will be volume-matched and administered subcutaneously (SC) once weekly.

Enicepatide: Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max 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

Primary outcome measure(s)

Trial sites (70)

FacilityCityRegionStatus
Central Alabama Research Birmingham Alabama
University of Alabama at Birmingham (UAB) Birmingham Alabama
Lakeview Clinical Research, LLC Guntersville Alabama
Yuma Clinical Trials Yuma Arizona
AMCR Institute Escondido California
Ark Clinical-Fountain Valley Fountain Valley California
Orange Country Research Center Lake Forest California
Ark Clinical Research Long Beach California
Catalina Research Institute, LLC Montclair California
Asclepes Research Centers Sherman Oaks California
Encompass Clinical Research Spring Valley California
Flourish Research - Boca Raton Boca Raton Florida
Tampa Bay Medical Research Clearwater Florida
K2 Medical Research, LLC - Maitland Maitland Florida
K2 Medical Research, LLC - Orlando Maitland Florida
Flourish Research Acquisition, LLC Miami Florida
K2 Medical Research, LLC - South Orlando Orlando Florida
Aging Well Associates St. Petersburg Florida
K2 Medical Research Tampa Tampa Florida
K2 Summit Research The Villages Florida
Privia Medical Group Georgia, LLC Fayetteville Georgia
Privia Medical Group Georgia - Thomasville Thomasville Georgia
Rophe Adult and Pediatric Medicine/SKYCRNG Union City Georgia
Duly Health and Care Lombard Illinois
McFarland Clinic Ames Iowa
Cotton O'Neil Clinical Research Center Topeka Kansas
NOLA Cares, LLC Metairie Louisiana
Flourish Research Acquisition, LLC dba Flourish Bowie Bowie Maryland
Centennial Medical Group Elkridge Maryland
NECCR PrimaCare Research LLC Fall River Massachusetts
Olive Branch Family Medical Center; Family Medicine Olive Branch Mississippi
SKY Integrative Medical Center/SKYCRNG Ridgeland Mississippi
University of Nebraska Medical Center Omaha Nebraska
Ellipsis Research Group Brooklyn New York
Accellacare of Cary Cary North Carolina
Accellacare - Hickory Hickory North Carolina
Accellacare of Rocky Mount Rocky Mount North Carolina
Accellacare of Piedmont Healthcare Statesville North Carolina
Accellacare of Wilmington, LLC Wilmington North Carolina
Accellacare Research of Winston Salem Winston-Salem North Carolina

+ 30 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06628362 on ClinicalTrials.gov ↗ ← All trials in the USA