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

Carmot Therapeutics

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: CT-388; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06628362

CT-388-104

XC45544 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 or diet and exercise and treatment with 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, non-proliferative diabetic retinopathy that requires acute treatment
• Have presence of active neuropathy (including 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 participation in an organized weight reduction program
• 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 for obesity
• Clinically significant or active gastric emptying abnormality, malabsorption, or chronic use of medications that directly affect GI motility
• History of chronic pancreatitis or acute pancreatitis within 6 months before screening
• Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
• History of major depressive disorder within 2 years of screening
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

360 participants in 5 patient groups, including a placebo group

Arm 1: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Arm 2: CT-388 Dose Level 1 (Low)

Experimental group

Treatment:

Drug: CT-388

Arm 3: CT-388 Dose Level 2

Experimental group

Treatment:

Drug: CT-388

Arm 4: CT-388 Dose Level 3

Experimental group

Treatment:

Drug: CT-388

Arm 5: CT-388 Dose Level 4 (High)

Experimental group

Treatment:

Drug: CT-388