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

Carmot Therapeutics

Status and phase: Active, not recruiting; 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, or any history/diagnosis of other severe psychiatric conditions (Note: Prospective participants with depression or anxiety whose disease state, in the opinion of the Investigator, is considered stable and expected to remain stable throughout the course of the study, may be considered for inclusion)
• 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