Clinical trial

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

Active, not recruiting · Phase 2 · 6 countries · Registry ID NCT06628362

Active, not recruitingPhase 2Interventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionOverweight or Obese, Type 2 Diabetes Mellitus (T2DM)

Full registry criteria

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

Treatments and study arms

Placebo

Drug

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

Enicepatide

Drug

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

Primary outcomes

Percent Change in Body Weight from Baseline to Week 36Baseline to Week 36
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36Baseline to Week 36

Study locations

70 locations were listed when this page was built. The first 40 are shown.

Centro Medico Viamonte SRL🇦🇷 Buenos Aires, Provincia de Buenos, Argentina
Aggarwal and Associates🇨🇦 Brampton, Ontario, Canada
Centricity Research Brampton Endocrinology🇨🇦 Brampton, Ontario, Canada
CEMDEC S.A. de C.V.🇲🇽 Cuauhtémoc, Mexico
Instituto de Diabetes Obesidad y Nutricion, SC🇲🇽 Cuernavaca, Mexico
SINACOR🇲🇽 Culiacán, Mexico
Centro De Investigacion En Artritis Y Osteopososis🇲🇽 Mexicali, Mexico
Clinicos Asociados Bocm, S.C.🇲🇽 Mexico City, Mexico
Medical Care and Research S.A de C.V🇲🇽 Mérida, Mexico
Avant Santé Research Center🇲🇽 San Pedro Garza García, Mexico
FAICIC S de R.L. de C.V🇲🇽 Veracruz, Mexico
Sociedad de Metabolismo y Corazon S.C.🇲🇽 Veracruz, Mexico
Momentum Pukekohe🇳🇿 Auckland, New Zealand
Optimal Clinical Trials🇳🇿 Grafton, New Zealand
Optimal Clinical Trials - North🇳🇿 Rosedale, Auckland, New Zealand
Tauranga Hospital🇳🇿 Tauranga, New Zealand
Momentum Wellington🇳🇿 Wellington, New Zealand
ISIS Clinical Research Center🇵🇷 Guaynabo, Puerto Rico
McFarland Clinic🇺🇸 Ames, Iowa, United States
FutureSearch Trials of Neurology🇺🇸 Austin, Texas, United States
Central Alabama Research🇺🇸 Birmingham, Alabama, United States
University of Alabama at Birmingham (UAB)🇺🇸 Birmingham, Alabama, United States
Flourish Research - Boca Raton🇺🇸 Boca Raton, Florida, United States
Flourish Research Acquisition, LLC dba Flourish Bowie🇺🇸 Bowie, Maryland, United States
Ellipsis Research Group🇺🇸 Brooklyn, New York, United States
Diabetes and Endocrinology Associates of Stark County, Inc.🇺🇸 Canton, Ohio, United States
Accellacare of Cary🇺🇸 Cary, North Carolina, United States
Tampa Bay Medical Research🇺🇸 Clearwater, Florida, United States
University of Texas Southwestern Medical Center Investigation Drug Services🇺🇸 Dallas, Texas, United States
Velocity Clinical Research - Dallas🇺🇸 Dallas, Texas, United States
Tekton Research🇺🇸 Edmond, Oklahoma, United States
Centennial Medical Group🇺🇸 Elkridge, Maryland, United States
AMCR Institute🇺🇸 Escondido, California, United States
NECCR PrimaCare Research LLC🇺🇸 Fall River, Massachusetts, United States
Privia Medical Group Georgia, LLC🇺🇸 Fayetteville, Georgia, United States
Ark Clinical-Fountain Valley🇺🇸 Fountain Valley, California, United States
Lakeview Clinical Research, LLC🇺🇸 Guntersville, Alabama, United States
Accellacare - Hickory🇺🇸 Hickory, North Carolina, United States
Juno Research, LLC🇺🇸 Houston, Texas, United States
Norwood Family Medicine🇺🇸 Knoxville, Tennessee, United States