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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-868 Low Dose | Experimental | 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 Medium Dose | Experimental | 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 High Dose | Experimental | 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 Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-868 | Drug | CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline | at Day 1 to Week 16 |
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Time In Range (TIR) as per Continuous Glucose Monitoring (CGM) metrics. | at Day 1 to Week 16 | |
| Time in hypoglycemia as per CGM metrics. | at Day 1 to Week 16 | |
| Time in hyperglycemia as per CGM metrics. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Carmot Therapeutics, Inc., a member of the Roche Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Muir Physician Network Clinical Research Center | Concord | California | 94520 | United States | ||
| Headlands Research- AMCR |
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| Label | URL |
|---|---|
| Related Info | View source |
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| CT-868 Pen Injector | Device | The CT-868 pen injector is a multi-dose, single-participant, disposable pen. |
|
| CT-868 Pen Injector, Placebo | Drug | The placebo pen injector is identical and contains the same ingredients except for CT-868. |
|
| 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 |
| at Day 1 to Week 16 |
| Escondido |
| California |
| 92025 |
| United States |
| University of Colorado - Barbara Davis Center for Diabetes | Aurora | Colorado | 80045 | United States |
| Denver Endocrinology Diabetes and Thyroid Center | Englewood | Colorado | 80113 | United States |
| 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 |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | United States |
| Rocky Mountain Clinical Research, LLC- Idaho Falls, Idaho | Idaho Falls | Idaho | 83404 | United States |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50266 | United States |
| MedStar Health Research Institute - Washington Hospital Center | Hyattsville | Maryland | 20782 | United States |
| 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 Health and Science University | Portland | Oregon | 97239 | United States |
| 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 |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 7, 2026 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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