A Study of CT-868 in Type 1 Diabetes Mellitus

Phase 2

Recruiting

• Conditions: Obese; Type 1 Diabetes Mellitus; Overweight
• Interventions: Drug: CT-868; Device: CT-868 Pen Injector

• Registration Number: NCT06062069
• Lead Sponsor: Carmot Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-29
• Study First Posted: 2023-10-02
• Study Start: 2023-10-19
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-21
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-868 Medium Dose	CT-868	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.
CT-868 Low Dose	CT-868	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.
CT-868 Low Dose	CT-868 Pen Injector	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.
CT-868 High Dose	CT-868	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.
CT-868 High Dose	CT-868 Pen Injector	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.
CT-868 Medium Dose	CT-868 Pen Injector	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.
CT-868 Placebo	CT-868 Pen Injector	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.

Primary Outcome Measures

Name	Time	Method
Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline	at Day 1 to Week 16

Secondary Outcome Measures

Name	Time	Method
To assess the percentage of participants achieving HbA1c of <7.0%.	at Week 16
To assess the percentage of participants achieving HbA1c of ≤6.5%.	at Week 16
Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline	at Day 1 to Weeks 4, 8, and 12
Change in body weight (in kilograms) from baseline when comparing CT-868 to placebo.	at Day 1 to Week 16
To assess the percentage of participants achieving HbA1c of <5.7%.	at Week 16
Change in insulin doses from baseline when comparing CT-868 to placebo.	at Day 1 to Weeks 8 and 16

Trial Locations

Locations (16)

Carmot Therapeutics Investigational Site 108; 🇺🇸 Shavano Park, Texas, United States

Carmot Therapeutics Investigational Site 109; 🇺🇸 Renton, Washington, United States

Carmot Therapeutics Investigational Site 103; 🇺🇸 Dallas, Texas, United States

Carmot Therapeutics Investigational Site 116; 🇺🇸 Port Charlotte, Florida, United States

Carmot Therapeutics Investigational Site 105; 🇺🇸 Dallas, Texas, United States

Carmot Therapeutics Investigational Site 102; 🇺🇸 Morehead City, North Carolina, United States

Carmot Therapeutics Investigational Site 101; 🇺🇸 Austin, Texas, United States

Carmot Therapeutics Investigational Site 111; 🇺🇸 Asheville, North Carolina, United States

Carmot Therapeutics Investigational Site 107; 🇺🇸 Detroit, Michigan, United States

Carmot Therapeutics Investigational Site 115; 🇺🇸 Weslaco, Texas, United States

Carmot Therapeutic Investigational Site 106; 🇺🇸 La Jolla, California, United States

Carmot Therapeutics Investigational Site 104; 🇺🇸 West Des Moines, Iowa, United States

Carmot Therapeutics Investigational Site 113; 🇺🇸 Orlando, Florida, United States

Carmot Therapeutics Investigational Site 112; 🇺🇸 Orlando, Florida, United States

Carmot Therapeutics Investigational Site 110; 🇺🇸 Chapel Hill, North Carolina, United States

Carmot Therapeutics Investigational Site 114; 🇺🇸 Hyattsville, Maryland, United States