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

Launched by CARMOT THERAPEUTICS, INC. · Oct 3, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called CT-388 for people who are overweight or obese and have Type 2 diabetes. The aim is to find out how effective and safe CT-388 is at different doses. The study will involve participants from various locations, and it is designed to compare CT-388 with a placebo (a treatment that looks the same but has no active ingredients) to see if there are any benefits.

To be eligible for the study, participants must be aged between 18 and 75, have a body mass index (BMI) of 25 or higher, and have been diagnosed with Type 2 diabetes. They should also have struggled with weight loss despite trying diet and exercise. Participants will be closely monitored throughout the trial to track their health and any side effects. It’s important to note that there are certain health conditions and recent treatments that could exclude someone from joining the trial, such as having Type 1 diabetes or recent major weight loss. If you think you might be interested, it could be a great opportunity to explore a new potential treatment for managing your diabetes and weight.

Gender

ALL

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