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Completed

NCT Number: NCT05110846

A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus

A study to assess the effect of CT-868 in lowering glycated hemoglobin A1c (HbA1c) in overweight and obese participants with inadequately controlled Type 2 diabetes mellitus (T2DM).

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes Mellitus

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Carmot Clinical Center MX04, Guadalajara, Jalisco, Mexico

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males or Females with T2DM
  • BMI of ≥27 kg/m2, inclusive
  • 18-75 years old, inclusive
  • Stable body weight for 3 months

Exclusion criteria

  • Significant medical history
  • Uncontrolled diabetes
  • History of malignancy

Treatment and study plan

Placebo

Drug

Participants self-injected once-daily subcutaneous volume- and regimen-matched placebo for 26 weeks.

CT-868

Drug

Participants self-injected once-daily subcutaneous CT-868 for 26 weeks according to the randomized dose and regimen.

Primary outcomes

  1. Change from Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 26

    Time frame: Baseline and Week 26

Secondary outcomes

  1. Change from Baseline in HbA1c at Week 12

    Time frame: Baseline and Week 12

  2. Percentage of Participants Achieving HbA1c <5.7% at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  3. Percentage of Participants Achieving HbA1c ≤6.5% at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  4. Percentage of Participants Achieving HbA1c <7.0% at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  5. Percent Change from Baseline in Body Weight at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  6. Absolute (kg) Change from Baseline in Body Weight at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  7. Percentage of Participants with ≥5% Body Weight Loss from Baseline at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  8. Percentage of Participants with ≥10% Body Weight Loss from Baseline at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  9. Percentage of Participants with ≥15% Body Weight Loss from Baseline at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  10. Percentage of Participants with ≥20% Body Weight Loss from Baseline at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  11. Change from Baseline in Fasting Plasma Glucose at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  12. Change from Baseline in Fasting Insulin at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  13. Change from Baseline in Waist Circumference at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  14. Change from Baseline in Hip Circumference at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  15. Change from Baseline in Waist-to-Hip Ratio at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  16. Change from Baseline in Waist-to-Height Ratio at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  17. Change from Baseline in Body Mass Index (BMI) at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  18. Change from Baseline in Total Cholesterol at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  19. Change from Baseline in Triglycerides at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  20. Change from Baseline in Low Density Lipoprotein (LDL) Cholesterol at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  21. Change from Baseline in High Density Lipoprotein (HDL) Cholesterol at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  22. Change from Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  23. Change from Baseline in Apolipoprotein B at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  24. Change from Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  25. Change from Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) at Weeks 12 and 26

    Time frame: Baseline and Weeks 12 and 26

  26. Percentage of Participants with at Least One Treatment-Emergent Adverse Event

    Time frame: From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks)

  27. Percentage of Participants with at Least One Hypoglycemic Event

    Time frame: From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks)

  28. Percentage of Participants Testing Positive for Anti-Drug Antibodies to CT-868 at Baseline and Anytime Post-Baseline

    Time frame: Baseline and Post-Baseline (up to 30 weeks)

Sponsors and collaborators

Lead sponsor

Carmot Therapeutics, Inc.

Industry

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple-Center Study to Evaluate the Efficacy, Safety, and Tolerability of CT-868 Administered for 26 Weeks to Overweight and Obese Participants With Type 2 Diabetes Mellitus

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2021
Registry last updated
Feb 5, 2026

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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