A Study of CT-868 in Type 1 Diabetes Mellitus

NCT ID: NCT06062069

Last Updated: 2025-07-17

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-19

Study Completion Date

2025-07-09

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obese Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Group Type EXPERIMENTAL

CT-868

Intervention Type DRUG

CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.

CT-868 Pen Injector

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

CT-868

Intervention Type DRUG

CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.

CT-868 Pen Injector

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

CT-868

Intervention Type DRUG

CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.

CT-868 Pen Injector

Intervention Type DEVICE

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.

Group Type PLACEBO_COMPARATOR

CT-868 Pen Injector

Intervention Type DEVICE

The CT-868 pen injector is a multi-dose, single-participant, disposable pen.

CT-868 Pen Injector, Placebo

Intervention Type DRUG

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.

Intervention Type DRUG

CT-868 Pen Injector

The CT-868 pen injector is a multi-dose, single-participant, disposable pen.

Intervention Type DEVICE

CT-868 Pen Injector, Placebo

The placebo pen injector is identical and contains the same ingredients except for CT-868.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carmot Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Headlands Research- AMCR

Escondido, California, United States

Site Status

University of Colorado - Barbara Davis Center for Diabetes

Aurora, Colorado, United States

Site Status

Denver Endocrinology Diabetes and Thyroid Center

Englewood, Colorado, United States

Site Status

Advent Health

Orlando, Florida, United States

Site Status

Orlando Health Science Clinic, LLC

Orlando, Florida, United States

Site Status

Innovative Research Institute

Port Charlotte, Florida, United States

Site Status

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Site Status

Rocky Mountain Clinical Research, LLC- Idaho Falls, Idaho

Idaho Falls, Idaho, United States

Site Status

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Site Status

MedStar Health Research Institute - Washington Hospital Center

Hyattsville, Maryland, United States

Site Status

University of North Carolina Health Sciences at MAHEC

Asheville, North Carolina, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Lucas Research, Inc

Morehead City, North Carolina, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Texas Diabetes and Endocrinology, P.A

Austin, Texas, United States

Site Status

Velocity Clinical Research - Dallas

Dallas, Texas, United States

Site Status

Research Institute of Dallas

Dallas, Texas, United States

Site Status

Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas, United States

Site Status

Consano Clinical Research

Shavano Park, Texas, United States

Site Status

Texas Valley Clinical Research, LLC

Weslaco, Texas, United States

Site Status

Rainier Clinical Research Center

Renton, Washington, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CT-868-004

Identifier Type: -

Identifier Source: org_study_id

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