A Study of CT-868 in Type 1 Diabetes Mellitus

  • Metabolic Disorder
  • Obesity
  • Type 1 Diabetes Mellitus
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Active, not recruiting

This study runs in
Country
  • United States
Study Identifier:

NCT06062069 CT-868-004

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      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.

      Carmot Therapeutics, Inc. Sponsor
      Phase 2 Phase
      NCT06062069, CT-868-004 Study Identifier
      CT-868, CT-868 Pen Injector, : CT-868 Pen Injector, Placebo Treatments
      Overweight, Obese, Type 1 Diabetes Mellitus Condition
      Official Title

      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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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