A Study of CT-868 in Type 1 Diabetes Mellitus

Carmot Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Type 1 Diabetes Mellitus; Obese; Overweight

Treatments: Drug: CT-868; Drug: : CT-868 Pen Injector, Placebo; Device: CT-868 Pen Injector

Study type: Interventional

Funder types: Industry

Identifiers

NCT06062069

CT-868-004

Details and patient eligibility

About

This study will evaluate the changes in glycemic control in overweight and obese adults with Type 1 Diabetes Mellitus after receiving CT-868 for 16 weeks. The effectiveness and safety of CT-868 will be compared to placebo. All participants will continue with their standard diabetes care using either an insulin pump (CSII) or multiple daily injections (MDI). Alongside their designated treatment, participants will receive guidance on managing their diabetes, including monitoring blood glucose levels and diet and exercise recommendations. Treatment assignments, either CT-868 plus insulin or placebo plus insulin will be randomly determined.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18 years of age or older at the time of signing informed consent
• Have a documented clinical diagnosis of T1DM greater than or equal to 1 year before the Screening Visit
• Body mass index greater than or equal to27.0 kg/m2
• Hemoglobin A1c (HbA1c) level between 7.0% and 10.0%, inclusive, at the Screening Visit

Exclusion criteria

• Diagnosis of Type 2 diabetes mellitus (T2DM) or any other types of diabetes, except T1DM
• Experienced diabetic ketoacidosis (DKA) within 3 months prior to the Screening Visit
• Experienced severe hypoglycemia (Level 3 as defined in the ADA Standards of Medical Care in Diabetes (ADA 2022) within 3 months prior to the Screening Visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 4 patient groups, including a placebo group

CT-868 Low Dose

Experimental group

Description:

Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 1.8 mg, and it will be administered once daily for a total duration of 16 weeks.

Treatment:

Device: CT-868 Pen Injector

Drug: CT-868

CT-868 Medium Dose

Experimental group

Description:

Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 4.1 mg, and it will be administered once daily for a total duration of 16 weeks.

Treatment:

Device: CT-868 Pen Injector

Drug: CT-868

CT-868 High Dose

Experimental group

Description:

Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 6.6 mg, and it will be administered once daily for a total duration of 16 weeks.

Treatment:

Device: CT-868 Pen Injector

Drug: CT-868

CT-868 Placebo

Placebo Comparator group

Description:

Participants in this arm will receive a placebo designed to match the appearance and formulation of the drug CT-868. The intervention consists of a subcutaneous injection of this placebo. The placebo will be administered once daily for a duration of 16 weeks.

Treatment:

Drug: : CT-868 Pen Injector, Placebo

Device: CT-868 Pen Injector