A Study of CT-868 in Type 1 Diabetes Mellitus

Last updated: July 14, 2025
Sponsor: Carmot Therapeutics, Inc.
Overall Status: Completed

Phase

2

Condition

Obesity

Diabetes Mellitus, Type 1

Diabetes And Hypertension

Treatment

: CT-868 Pen Injector, Placebo

CT-868 Pen Injector

CT-868

Clinical Study ID

NCT06062069
CT-868-004
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 beforethe 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 ScreeningVisit

Exclusion

Exclusion Criteria:

  • Diagnosis of Type 2 diabetes mellitus (T2DM) or any other types of diabetes, exceptT1DM

  • Experienced diabetic ketoacidosis (DKA) within 3 months prior to the Screening Visit

  • Experienced severe hypoglycemia (Level 3 as defined in the ADA Standards of MedicalCare in Diabetes (ADA 2022) within 3 months prior to the Screening Visit

Study Design

Total Participants: 111
Treatment Group(s): 4
Primary Treatment: : CT-868 Pen Injector, Placebo
Phase: 2
Study Start date:
October 19, 2023
Estimated Completion Date:
July 09, 2025

Connect with a study center

  • Carmot Therapeutics Investigational Site 121

    Concord, California 94520
    United States

    Site Not Available

  • John Muir Physician Network Clinical Research Center

    Concord, California 94520
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 125

    Escondido, California 92025
    United States

    Site Not Available

  • Headlands Research- AMCR

    Escondido, California 92025
    United States

    Site Not Available

  • Carmot Therapeutic Investigational Site 106

    La Jolla, California 92037
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 118

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado - Barbara Davis Center for Diabetes

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 119

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Denver Endocrinology Diabetes and Thyroid Center

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Advent Health

    Orlando, Florida 32804
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 112

    Orlando, Florida 32822
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 113

    Orlando, Florida 32804
    United States

    Site Not Available

  • Orlando Health Science Clinic, LLC

    Orlando, Florida 32822
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 116

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Innovative Research Institute

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Atlanta Diabetes Associates

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 123

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 126

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Rocky Mountain Clinical Research, LLC- Idaho Falls, Idaho

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 104

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 114

    Hyattsville, Maryland 20782
    United States

    Site Not Available

  • MedStar Health Research Institute - Washington Hospital Center

    Hyattsville, Maryland 20782
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 107

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 111

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • University of North Carolina Health Sciences at MAHEC

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 110

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 102

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Lucas Research, Inc

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 122

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 101

    Austin, Texas 78731
    United States

    Site Not Available

  • Texas Diabetes and Endocrinology, P.A

    Austin, Texas 78731
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 103

    Dallas, Texas 75230
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 105

    Dallas, Texas 75231
    United States

    Site Not Available

  • Research Institute of Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Velocity Clinical Research - Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 124

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 108

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Consano Clinical Research

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 115

    Weslaco, Texas 78596
    United States

    Site Not Available

  • Texas Valley Clinical Research, LLC

    Weslaco, Texas 78596
    United States

    Site Not Available

  • Carmot Therapeutics Investigational Site 109

    Renton, Washington 98057
    United States

    Site Not Available

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Site Not Available

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