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| Name | Class |
|---|---|
| Zealand Pharma | INDUSTRY |
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The main purpose of this study is to evaluate the safety and efficacy of the co-administration of petrelintide and enicepatide compared with placebo, petrelintide monotherapy, and enicepatide monotherapy in participants with obesity or overweight with at least one weight-related comorbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Petrelintide + Enicepatide Dosing Regimen 1 | Experimental |
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| Arm 2: Petrelintide + Enicepatide Dosing Regimen 2 | Experimental |
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| Arm 3: Petrelintide + Enicepatide Dosing Regimen 3 | Experimental |
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| Arm 4: Petrelintide-matching Placebo + Enicepatide | Experimental |
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| Arm 5: Petrelintide + Enicepatide-matching Placebo | Experimental |
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| Arm 6: Petrelintide-matching Placebo + Enicepatide-matching Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Petrelintide | Drug | Petrelintide will be administered subcutaneously to participants once weekly |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Body Weight between Arms 1 and 6 | From Baseline to Week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Body Weight between Arms 2, 3 and Arm 6 | From Baseline to Week 40 | |
| Percentage Change in Body Weight between Arms 1, 2, 3 and Arms 4, 5 | From Baseline to Week 40 | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: CC46372 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Enicepatide | Combination Product | Enicepatide will be administered subcutaneously to participants once weekly |
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| Petrelintide-matching Placebo | Drug | Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly |
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| Enicepatide-matching Placebo | Combination Product | Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly |
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| Percentage of Participants Achieving Body Weight Loss |
| From Baseline to Week 40 |
| Change in Body Weight (kilograms [kg]) | From Baseline to Week 40 |
| Change in Body Mass Index (kilograms per square meter [kg/m²]) | From Baseline to Week 40 |
| Change in Waist Circumference (centimeter [cm]) | From Baseline to Week 40 |
| Change in Hemoglobin A1c (HbA1c) (percentage-points) | From Baseline to Week 40 |
| Change in Fasting Insulin | From Baseline to Week 40 |
| Change in Fasting Glucose | From Baseline to Week 40 |
| Change in Systolic Blood Pressure | From Baseline to Week 40 |
| Change in Diastolic Blood Pressure | From Baseline to Week 40 |
| Change in High-Density Lipoprotein (HDL) Cholesterol | From Baseline to Week 40 |
| Change in Low-Density Lipoprotein (LDL) Cholesterol | From Baseline to Week 40 |
| Change in Very-Low-Density Lipoprotein (VLDL) Cholesterol | From Baseline to Week 40 |
| Change in Non-HDL Cholesterol | From Baseline to Week 40 |
| Change in Total Cholesterol | From Baseline to Week 40 |
| Change in Free Fatty Acids | From Baseline to Week 40 |
| Change in Triglycerides | From Baseline to Week 40 |
| Change in High-Sensitivity C-reactive Protein (hsCRP) | From Baseline to Week 40 |
| Number of Participants with Adverse Events (AEs) | From Baseline to Week 40 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |