A Study of CT-868 in Type 1 Diabetes Mellitus

July 14, 2025 updated by: Carmot Therapeutics, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Concord, California, United States, 94520
        • John Muir Physician Network Clinical Research Center
      • Escondido, California, United States, 92025
        • Headlands Research- AMCR
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado - Barbara Davis Center for Diabetes
      • Englewood, Colorado, United States, 80113
        • Denver Endocrinology Diabetes and Thyroid Center
    • Florida
      • Orlando, Florida, United States, 32804
        • Advent Health
      • Orlando, Florida, United States, 32822
        • Orlando Health Science Clinic, LLC
      • Port Charlotte, Florida, United States, 33952
        • Innovative Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Atlanta Diabetes Associates
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Clinical Research, LLC- Idaho Falls, Idaho
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Diabetes and Endocrinology Research Center
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • MedStar Health Research Institute - Washington Hospital Center
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • University of North Carolina Health Sciences at MAHEC
      • Chapel Hill, North Carolina, United States, 27517
        • University of North Carolina at Chapel Hill
      • Morehead City, North Carolina, United States, 28557
        • Lucas Research, Inc
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Diabetes and Endocrinology, P.A
      • Dallas, Texas, United States, 75231
        • Research Institute Of Dallas
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research - Dallas
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Clinic, P.A.
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research
      • Weslaco, Texas, United States, 78596
        • Texas Valley Clinical Research, LLC
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: CT-868
CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.
Device: CT-868 Pen Injector
The CT-868 pen injector is a multi-dose, single-participant, disposable pen.
Experimental: 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.
Drug: CT-868
CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.
Device: CT-868 Pen Injector
The CT-868 pen injector is a multi-dose, single-participant, disposable pen.
Experimental: 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.
Drug: CT-868
CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.
Device: CT-868 Pen Injector
The CT-868 pen injector is a multi-dose, single-participant, disposable pen.
Placebo Comparator: 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.
Device: CT-868 Pen Injector
The CT-868 pen injector is a multi-dose, single-participant, disposable pen.
Drug: CT-868 Pen Injector, Placebo
The placebo pen injector is identical and contains the same ingredients except for CT-868.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline
Time Frame: at Day 1 to Week 16
at Day 1 to Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline
Time Frame: at Day 1 to Weeks 4, 8, and 12
at Day 1 to Weeks 4, 8, and 12
To assess the percentage of participants achieving HbA1c of <7.0%.
Time Frame: at Week 16
at Week 16
To assess the percentage of participants achieving HbA1c of ≤6.5%.
Time Frame: at Week 16
at Week 16
To assess the percentage of participants achieving HbA1c of <5.7%.
Time Frame: at Week 16
at Week 16
Change in body weight (in kilograms) from baseline when comparing CT-868 to placebo.
Time Frame: at Day 1 to Week 16
at Day 1 to Week 16
Change in insulin doses from baseline when comparing CT-868 to placebo.
Time Frame: at Day 1 to Weeks 8 and 16
at Day 1 to Weeks 8 and 16

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Time In Range (TIR) as per Continuous Glucose Monitoring (CGM) metrics.
Time Frame: at Day 1 to Week 16
at Day 1 to Week 16
Time in hypoglycemia as per CGM metrics.
Time Frame: at Day 1 to Week 16
at Day 1 to Week 16
Time in hyperglycemia as per CGM metrics.
Time Frame: at Day 1 to Week 16
at Day 1 to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carmot Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Carmot Therapeutics, Inc., a Member of the Roche Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT-868-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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