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| ID | Type | Description | Link |
|---|---|---|---|
| BP45664 | Other Identifier | Roche Protocol Number |
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants in the placebo arm received volume- and regimen-matched placebo. |
|
| CT-868 1.75 mg | Experimental | Participants in the CT-868 1.75 mg arm received 1.0 mg/day for 2 weeks followed by 1.75 mg/day for the remaining treatment period. |
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| CT-868 4.0 mg | Experimental | Participants in the CT-868 4.0 mg arm escalated through 1.0 mg/day for 2 weeks, 1.75 mg/day for 2 weeks, 2.5 mg/day for 4 weeks, 3.25 mg/day for 4 weeks, to 4.0 mg/day for the remaining 14 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants self-injected once-daily subcutaneous volume- and regimen-matched placebo for 26 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 26 | Baseline and Week 26 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Carmot Therapeutics, Inc., a Member of the Roche Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carmot Clinical Center MX04 | Guadalajara | Jalisco | Mexico | |||
| Carmot Clinical Center MX01 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| CT-868 | Drug | Participants self-injected once-daily subcutaneous CT-868 for 26 weeks according to the randomized dose and regimen. |
|
| 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) |
| Monterrey |
| Nuevo León |
| Mexico |
| Carmot Clinical Center MX02 | Monterrey | Nuevo León | Mexico |
| Carmot Clinical Center MX05 | Mérida | Yucatán | Mexico |
| Carmot Clinical Center MX03 | Mexico City | Mexico |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |