a study of ct-388 in participants who are overweight or obese with type 2 diabetes mellitus

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

Summary: this is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of ct-388 at low, middle, and high doses in participants who are overweight or obese with type 2 diabetes mellitus (t2dm).


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