Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
111 participants
INTERVENTIONAL
2023-10-19
2025-07-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CT-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.
CT-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.
CT-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.
CT-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.
Interventions
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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.
CT-868 Pen Injector, Placebo
The placebo pen injector is identical and contains the same ingredients except for CT-868.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Carmot Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Carmot Therapeutics, Inc., a member of the Roche Group
Locations
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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
Countries
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Related Links
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Related Info
Other Identifiers
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CT-868-004
Identifier Type: -
Identifier Source: org_study_id
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