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OpenTrials
Completed

NCT Number: NCT06062069

A Study of CT-868 in 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.

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Key information

Conditions

Overweight Autoimmune Diseases Body Weight Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 1 Diabetes Mellitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

John Muir Physician Network Clinical Research Center, Concord, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT-868

Drug

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

CT-868 Pen Injector

Device

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

CT-868 Pen Injector, Placebo

Drug

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

Primary outcomes

  1. Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline

    Time frame: at Day 1 to Week 16

Secondary outcomes

  1. 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

  2. To assess the percentage of participants achieving HbA1c of <7.0%.

    Time frame: at Week 16

  3. To assess the percentage of participants achieving HbA1c of ≤6.5%.

    Time frame: at Week 16

  4. To assess the percentage of participants achieving HbA1c of <5.7%.

    Time frame: at Week 16

  5. Change in body weight (in kilograms) from baseline when comparing CT-868 to placebo.

    Time frame: at Day 1 to Week 16

  6. Change in insulin doses from baseline when comparing CT-868 to placebo.

    Time frame: at Day 1 to Weeks 8 and 16

Other outcomes

  1. Time In Range (TIR) as per Continuous Glucose Monitoring (CGM) metrics.

    Time frame: at Day 1 to Week 16

  2. Time in hypoglycemia as per CGM metrics.

    Time frame: at Day 1 to Week 16

  3. Time in hyperglycemia as per CGM metrics.

    Time frame: at Day 1 to Week 16

Sponsors and collaborators

Lead sponsor

Carmot Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2023
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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