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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521401-41-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to assess the effect of RO7204239 on insulin sensitivity versus placebo in participants with T2DM and obesity or overweight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | Participants will receive RO7204239 matching placebo, every 4 weeks (Q4W), as a subcutaneous (SC) injection for 24 weeks. |
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| RO7204239 | Experimental | Participants will receive RO7204239, Q4W, as a SC injection for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | RO7204239 matching placebo will be administered as per the schedule specified in the treatment arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in M-value in a Hyperinsulinemic Euglycemic Glucose Clamp (HEC) at Week 24 | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 and 24 | Baseline, Week 12, Week 24 | |
| Change From Baseline in Glucose Metabolism Assessed Using Fasting Glucose Test at Weeks 12 and 24 | Baseline, Week 12, Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung | Homburg | Saarland | 66421 | Germany |
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| RO7204239 | Drug | RO7204239 will be administered as per the schedule specified in the treatment arm. |
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| Change From Baseline in Glucose Metabolism Assessed Using Insulin Test at Weeks 12 and 24 | Baseline, Week 12, Week 24 |
| Change From Baseline in Glucose Metabolism Assessed Using C-peptide Test at Weeks 12 and 24 | Baseline, Week 12, Week 24 |
| Change From Baseline in Blood Lipid Profiles at Weeks 12 and 24 | Baseline, Week 12, Week 24 |
| Change From Baseline in Body Weight at Weeks 12 and 24 | Baseline, Week 12, Week 24 |
| Change From Baseline in Waist Circumference at Weeks 12 and 24 | Baseline, Week 12, Week 24 |
| Change From Baseline in Waist to Height Ratio at Weeks 12 and 24 | Baseline, Week 12, Week 24 |
| Change From Baseline in Total Lean Tissue Volume and Total Adipose Tissue Volume From Abdominal Magnetic Resonance Imaging (MRI) at Weeks 12 and 24 | Baseline, Week 12, Week 24 |
| Change From Baseline in Muscle Volume From Thigh Muscle MRI at Weeks 12 and 24 | Baseline, Week 12, Week 24 |
| Change From Baseline in Muscle Fat Infiltration From Thigh Muscle MRI at Weeks 12 and 24 | Baseline, Week 12, Week 24 |
| Number of Participants With Adverse Events (AEs) | Up to Week 48 |
| Number of Participants With Local and Systemic Injection Reactions | Up to Week 48 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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