A Study of CT-868 in Type 1 Diabetes Mellitus

• Status: Recruiting
• Trial end date: 2024-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carmot Therapeutics, Inc.

Criteria

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