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| ID | Type | Description | Link |
|---|---|---|---|
| J2S-MC-GZMU | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate how different dose levels of brenipatide work and how safe they are in healthy people with overweight or obesity. The study will assess the effects of different doses given as subcutaneous (under the skin) injections. Participation in this study will last about 42 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brenipatide | Experimental | Participants will receive brenipatide subcutaneously (SC). |
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| Placebo | Placebo Comparator | Participants will receive placebo administered SC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brenipatide | Drug | Administered SC. |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Body Weight | Week 1, Week 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who discontinued due to an Adverse Events (AEs) | Day 1 through Week 37 | |
| Percentage of Participants Discontinuing Treatment due to Gastrointestinal (GI) AEs | Day 1 through Week 37 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit - Daytona Beach | Recruiting | Daytona Beach | Florida | 32117-5116 | United States |
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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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| Placebo | Other | Administered SC. |
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| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Brenipatide | Pre-dose on Day 1 through Week 37 |
| PK: Maximum Concentration (Cmax) of Brenipatide | Pre-dose on Day 1 through Week 37 |
| Percentage of Participants Achieving ≥ 5% Reduction in Body Weight | Week 29 |
| Change in Waist Circumference | Week 1, Week 29 |
| Change in Waist-to-Height Ratio | Week 1, Week 29 |
| Change in Blood Pressure | Week 1, Week 29 |
| Change in Fasting Low-density Lipoprotein- Cholesterol (LDL-C) | Week 1, Week 29 |
| Change in High-sensitive C-reactive Protein (hsCRP) | Week 1, Week 29 |
| Fortrea Clinical Research Unit | Recruiting | Dallas | Texas | 75247 | United States |
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| Fortrea Clinical Research Unit Inc. - Madison | Recruiting | Madison | Wisconsin | 53704 | United States |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |