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)
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.
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.
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