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

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: Completed
• Conditions: Overweight; Type 1 Diabetes Mellitus; Obese
• Intervention / Treatment: Drug: CT-868; Device: CT-868 Pen Injector; Drug: CT-868 Pen Injector, Placebo

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline	at Day 1 to Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change in insulin doses from baseline when comparing CT-868 to placebo.	at Day 1 to Weeks 8 and 16

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Carmot Therapeutics, Inc.
• Investigators: Study Director: Clinical Trials, Carmot Therapeutics, Inc., a Member of the Roche Group

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Actual): July 9, 2025
• Study Completion (Actual): July 9, 2025

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 29, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Overweight; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID 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