A Study of CT-868 in Type 1 Diabetes Mellitus
Completed · Phase 2 · Has a placebo group
Conditions studied: Overweight, Obese, Type 1 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT06062069
- Run by
- Carmot Therapeutics, Inc.
- People needed
- 111
- Starts
- 2023-10-19
- Expected to finish
- 2025-07-09
- Last updated by the study team
- 2025-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- John Muir Physician Network Clinical Research Center — Concord, California, United States
- Headlands Research- AMCR — Escondido, California, United States
- University of Colorado - Barbara Davis Center for Diabetes — Aurora, Colorado, United States
- Denver Endocrinology Diabetes and Thyroid Center — Englewood, Colorado, United States
- Advent Health — Orlando, Florida, United States
- Orlando Health Science Clinic, LLC — Orlando, Florida, United States
- Innovative Research Institute — Port Charlotte, Florida, United States
- Atlanta Diabetes Associates — Atlanta, Georgia, United States
- Rocky Mountain Clinical Research, LLC- Idaho Falls, Idaho — Idaho Falls, Idaho, United States
- Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
- MedStar Health Research Institute - Washington Hospital Center — Hyattsville, Maryland, United States
- University of North Carolina Health Sciences at MAHEC — Asheville, North Carolina, United States
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Lucas Research, Inc — Morehead City, North Carolina, United States
- Oregon Health and Science University — Portland, Oregon, United States
- Texas Diabetes and Endocrinology, P.A — Austin, Texas, United States
- Velocity Clinical Research - Dallas — Dallas, Texas, United States
- Research Institute of Dallas — Dallas, Texas, United States
- Diabetes & Glandular Disease Clinic, P.A. — San Antonio, Texas, United States
- Consano Clinical Research — Shavano Park, Texas, United States
- Texas Valley Clinical Research, LLC — Weslaco, Texas, United States
- Rainier Clinical Research Center — Renton, Washington, United States
Full record on ClinicalTrials.gov
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