Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06062069 for Overweight, Obese, Type 1 Diabetes Mellitus is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
A Study of CT-868 in Type 1 Diabetes Mellitus Phase 2 111 Dietary Exercise-Based
Clinical Trial NCT06062069 was designed to study Treatment for Overweight, Obese, Type 1 Diabetes Mellitus. This was a Phase 2 interventional study that is now completed. The study started on 19 October 2023, with plans to enroll 111 participants. Led by Carmot Therapeutics, Inc., the expected completion date was 9 July 2025. The latest data from ClinicalTrials.gov was last updated on 17 July 2025.
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 rece...Show More
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
Conditions
OverweightObeseType 1 Diabetes MellitusOther Study IDs
- CT-868-004
NCT ID Number
Start Date (Actual)
2023-10-19
Last Update Posted
2025-07-17
Completion Date (Estimated)
2025-07-09
Enrollment (Estimated)
111
Study Type
Interventional
PHASE
Phase 2
Status
Completed
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCT-868 Low Dose 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 CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device. CT-868 Pen Injector The CT-868 pen injector is a multi-dose, single-participant, disposable pen. |
ExperimentalCT-868 Medium Dose 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 CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device. CT-868 Pen Injector The CT-868 pen injector is a multi-dose, single-participant, disposable pen. |
ExperimentalCT-868 High Dose 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 CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device. CT-868 Pen Injector The CT-868 pen injector is a multi-dose, single-participant, disposable pen. |
Placebo ComparatorCT-868 Placebo 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. | CT-868 Pen Injector The CT-868 pen injector is a multi-dose, single-participant, disposable pen. CT-868 Pen Injector, Placebo The placebo pen injector is identical and contains the same ingredients except for CT-868. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline | at Day 1 to Week 16 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline | at Day 1 to Weeks 4, 8, and 12 | |
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 | |
To assess the percentage of participants achieving HbA1c of <5.7%. | at Week 16 | |
Change in body weight (in kilograms) from baseline when comparing CT-868 to placebo. | at Day 1 to Week 16 | |
Change in insulin doses from baseline when comparing CT-868 to placebo. | at Day 1 to Weeks 8 and 16 |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Carmot Therapeutics, Inc.No contact data.
22 Study Locations in 1 Countries
California
John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States
Headlands Research- AMCR, Escondido, California, 92025, United States
Colorado
University of Colorado - Barbara Davis Center for Diabetes, Aurora, Colorado, 80045, United States
Denver Endocrinology Diabetes and Thyroid Center, Englewood, Colorado, 80113, United States
Florida
Advent Health, Orlando, Florida, 32804, United States
Orlando Health Science Clinic, LLC, Orlando, Florida, 32822, United States
Innovative Research Institute, Port Charlotte, Florida, 33952, United States
Georgia
Atlanta Diabetes Associates, Atlanta, Georgia, 30309, United States
Idaho
Rocky Mountain Clinical Research, LLC- Idaho Falls, Idaho, Idaho Falls, Idaho, 83404, United States
Iowa
Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50266, United States
Maryland
MedStar Health Research Institute - Washington Hospital Center, Hyattsville, Maryland, 20782, United States
North Carolina
University of North Carolina Health Sciences at MAHEC, Asheville, North Carolina, 28803, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27517, United States
Lucas Research, Inc, Morehead City, North Carolina, 28557, United States
Oregon
Oregon Health and Science University, Portland, Oregon, 97239, United States
Texas
Texas Diabetes and Endocrinology, P.A, Austin, Texas, 78731, United States
Velocity Clinical Research - Dallas, Dallas, Texas, 75230, United States
Research Institute of Dallas, Dallas, Texas, 75231, United States
Diabetes & Glandular Disease Clinic, P.A., San Antonio, Texas, 78229, United States
Consano Clinical Research, Shavano Park, Texas, 78231, United States
Texas Valley Clinical Research, LLC, Weslaco, Texas, 78596, United States
Washington
Rainier Clinical Research Center, Renton, Washington, 98057, United States