Obesity, Overweight, Type 2 Diabetes Mellitus
Conditions
Brief summary
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).
Interventions
DRUGPlacebo
Participants self-injected once-daily subcutaneous volume- and regimen-matched placebo for 26 weeks.
DRUGCT-868
Participants self-injected once-daily subcutaneous CT-868 for 26 weeks according to the randomized dose and regimen.
Sponsors
Carmot Therapeutics, Inc.
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 26 | Baseline and Week 26 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in HbA1c at Week 12 | Baseline and Week 12 |
| Percentage of Participants Achieving HbA1c <5.7% at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Percentage of Participants Achieving HbA1c ≤6.5% at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Percentage of Participants Achieving HbA1c <7.0% at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Percent Change from Baseline in Body Weight at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Absolute (kg) Change from Baseline in Body Weight at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Percentage of Participants with ≥5% Body Weight Loss from Baseline at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Percentage of Participants with ≥10% Body Weight Loss from Baseline at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Percentage of Participants with ≥15% Body Weight Loss from Baseline at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Percentage of Participants with ≥20% Body Weight Loss from Baseline at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Change from Baseline in Fasting Plasma Glucose at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Change from Baseline in Fasting Insulin at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Change from Baseline in Waist Circumference at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Change from Baseline in Hip Circumference at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Change from Baseline in Waist-to-Hip Ratio at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Change from Baseline in Waist-to-Height Ratio at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Change from Baseline in Body Mass Index (BMI) at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Change from Baseline in Total Cholesterol at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Change from Baseline in Triglycerides at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Change from Baseline in Low Density Lipoprotein (LDL) Cholesterol at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Change from Baseline in High Density Lipoprotein (HDL) Cholesterol at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Change from Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Change from Baseline in Apolipoprotein B at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Change from Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Change from Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) at Weeks 12 and 26 | Baseline and Weeks 12 and 26 |
| Percentage of Participants with at Least One Treatment-Emergent Adverse Event | From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks) |
| Percentage of Participants with at Least One Hypoglycemic Event | From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks) |
| Percentage of Participants Testing Positive for Anti-Drug Antibodies to CT-868 at Baseline and Anytime Post-Baseline | Baseline and Post-Baseline (up to 30 weeks) |
Countries
Mexico
Contacts
STUDY_DIRECTORClinical Trials
Carmot Therapeutics, Inc., a Member of the Roche Group
Outcome results
None listed