A Study of CT-388 in Participants with Obesity or Overweight with At Least One Weight-Related Comorbidity

Carmot Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: CT-388; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06525935

XC45526 (Other Identifier)

CT-388-103

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 with obesity or who are overweight with at least one weight-related comorbidity.

Enrollment: 450 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) ≥30.0 kg/m2, OR BMI ≥27.0 and <30.0 kg/m2 and previously diagnosed with at least 1 of the following weight-related comorbidities, such as: prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
• At least one self-reported unsuccessful effort to lose body weight

Exclusion criteria

• Prior history/diagnosis/lab evidence of any type of diabetes mellitus (e.g., Type 1, Type 2, gestational), or a history of ketoacidosis or hyperosmolar state
• Self-reported body weight change of >5 kg within 3 months before randomization
• Any unbalanced/extreme 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
• Serum calcitonin ≥ 20 ng/L
• 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

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450 participants in 6 patient groups, including a placebo group

Arm 1: Placebo

Placebo Comparator group

Description:

Placebo administered subcutaneously (SC) once weekly.

Treatment:

Drug: Placebo

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

Experimental group

Description:

CT-388 Dose Level 1 administered SC once weekly.

Treatment:

Drug: CT-388

Arm 3: CT-388 Dose Level 2

Experimental group

Description:

CT-388 Dose Level 2 administered SC once weekly.

Treatment:

Drug: CT-388

Arm 4: CT-388 Dose Level 3

Experimental group

Description:

CT-388 Dose Level 3 administered SC once weekly.

Treatment:

Drug: CT-388

Arm 5: CT-388 Dose Level 4

Experimental group

Description:

CT-388 Dose Level 4 administered SC once weekly.

Treatment:

Drug: CT-388

Arm 6: CT-388 Dose Level 5 (High)

Experimental group

Description:

CT-388 Dose Level 5 administered SC once weekly.

Treatment:

Drug: CT-388