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NCT06062069 Clinical Trial

A Study of CT-868 in Type 1 Diabetes Mellitus

Overweight Clinical Trial

Official title:
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of CT-868 Administered for 16 Weeks to Overweight and Obese Adult Participants With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06062069
Other study ID # CT-868-004
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 19, 2023
Est. completion date October 31, 2024

Study information
Verified date December 2023
Source Carmot Therapeutics, Inc.
Contact Michael Elliott
Phone 510-666-6328
Email melliott@carmot.us
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 96
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CT-868
CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.
Device:
• CT-868 Pen Injector
The CT-868 pen injector is a multi-dose, single-participant, disposable pen.
Drug:
• : CT-868 Pen Injector, Placebo
The placebo pen injector is identical and contains the same ingredients except for CT-868.

Locations
Country Name City State
United States Carmot Therapeutics Investigational Site 111 Asheville North Carolina
United States Carmot Therapeutics Investigational Site 101 Austin Texas
United States Carmot Therapeutics Investigational Site 110 Chapel Hill North Carolina
United States Carmot Therapeutics Investigational Site 103 Dallas Texas
United States Carmot Therapeutics Investigational Site 105 Dallas Texas
United States Carmot Therapeutics Investigational Site 107 Detroit Michigan
United States Carmot Therapeutics Investigational Site 114 Hyattsville Maryland
United States Carmot Therapeutic Investigational Site 106 La Jolla California
United States Carmot Therapeutics Investigational Site 102 Morehead City North Carolina
United States Carmot Therapeutics Investigational Site 112 Orlando Florida
United States Carmot Therapeutics Investigational Site 113 Orlando Florida
United States Carmot Therapeutics Investigational Site 116 Port Charlotte Florida
United States Carmot Therapeutics Investigational Site 109 Renton Washington
United States Carmot Therapeutics Investigational Site 108 Shavano Park Texas
United States Carmot Therapeutics Investigational Site 115 Weslaco Texas
United States Carmot Therapeutics Investigational Site 104 West Des Moines Iowa

Sponsors (1)
Lead Sponsor Collaborator
Carmot Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Time In Range (TIR) as per Continuous Glucose Monitoring (CGM) metrics. at Day 1 to Week 16
Other Time in hypoglycemia as per CGM metrics. at Day 1 to Week 16
Other Time in hyperglycemia as per CGM metrics. at Day 1 to Week 16
Primary Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline at Day 1 to Week 16
Secondary Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline at Day 1 to Weeks 4, 8, and 12
Secondary To assess the percentage of participants achieving HbA1c of <7.0%. at Week 16
Secondary To assess the percentage of participants achieving HbA1c of =6.5%. at Week 16
Secondary To assess the percentage of participants achieving HbA1c of <5.7%. at Week 16
Secondary Change in body weight (in kilograms) from baseline when comparing CT-868 to placebo. at Day 1 to Week 16
Secondary Change in insulin doses from baseline when comparing CT-868 to placebo. at Day 1 to Weeks 8 and 16
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