Active, not recruiting
Phase 2
A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus
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
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)
- Percent Change in Body Weight from Baseline to Week 36 — Baseline to Week 36
- Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36 — Baseline to Week 36
Trial sites (70)
| Facility | City | Region | Status |
| 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.
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