A Study of CT-868 in Type 1 Diabetes Mellitus
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
1 other identifier
interventional
111
1 country
22
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2023
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2023
CompletedFirst Posted
Study publicly available on registry
October 2, 2023
CompletedStudy Start
First participant enrolled
October 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2025
CompletedJuly 17, 2025
July 1, 2025
1.7 years
September 14, 2023
July 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline
at Day 1 to Week 16
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Other Outcomes (3)
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.
at Day 1 to Week 16
Study Arms (4)
CT-868 Low Dose
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.
The CT-868 pen injector is a multi-dose, single-participant, disposable pen.
The placebo pen injector is identical and contains the same ingredients except for CT-868.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
John Muir Physician Network Clinical Research Center
Concord, California, 94520, United States
Headlands Research- AMCR
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Carmot Therapeutics, Inc., a member of the Roche Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2023
First Posted
October 2, 2023
Study Start
October 19, 2023
Primary Completion
July 9, 2025
Study Completion
July 9, 2025
Last Updated
July 17, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share