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

NCT06628362

Active Not RecruitingPhase 2

Sponsor: Carmot Therapeutics, Inc.

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

Interventions: Placebo, Enicepatide

Countries: United States, Argentina, Canada, Mexico, New Zealand, Puerto Rico

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (70)
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Guntersville, Alabama, United States
  • Yuma, Arizona, United States
  • Escondido, California, United States
  • Fountain Valley, California, United States
  • Lake Forest, California, United States
  • Long Beach, California, United States
  • Montclair, California, United States
  • Sherman Oaks, California, United States
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  • Fayetteville, Georgia, United States
  • Thomasville, Georgia, United States
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  • Lombard, Illinois, United States
  • Ames, Iowa, United States
  • Topeka, Kansas, United States
  • Metairie, Louisiana, United States
  • Bowie, Maryland, United States
  • Elkridge, Maryland, United States
  • Fall River, Massachusetts, United States
  • + 40 more on CT.gov