A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus

Carmot Therapeutics

Status and phase: Completed; Phase 2

Conditions: Overweight; Type 2 Diabetes Mellitus; Obesity

Treatments: Drug: CT-868; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05110846

CT-868-002

BP45664 (Other Identifier)

Details and patient eligibility

About

A study to assess the effect of CT-868 in lowering glycated hemoglobin A1c (HbA1c) in overweight and obese participants with inadequately controlled Type 2 diabetes mellitus (T2DM).

Enrollment: 103 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or Females with T2DM
• BMI of ≥27 kg/m2, inclusive
• 18-75 years old, inclusive
• Stable body weight for 3 months

Exclusion criteria

• Significant medical history
• Uncontrolled diabetes
• History of malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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103 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants in the placebo arm received volume- and regimen-matched placebo.

Treatment:

Drug: Placebo

CT-868 1.75 mg

Experimental group

Description:

Participants in the CT-868 1.75 mg arm received 1.0 mg/day for 2 weeks followed by 1.75 mg/day for the remaining treatment period.

Treatment:

Drug: CT-868

CT-868 4.0 mg

Experimental group

Description:

Participants in the CT-868 4.0 mg arm escalated through 1.0 mg/day for 2 weeks, 1.75 mg/day for 2 weeks, 2.5 mg/day for 4 weeks, 3.25 mg/day for 4 weeks, to 4.0 mg/day for the remaining 14 weeks.

Treatment:

Drug: CT-868