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This is a multicenter, randomized, double-blind, placebo-controlled, multiple dose study to evaluate the efficacy, safety, and tolerability of taldefgrobep alfa in adults with overweight and obesity, with an open-label extension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taldefgrobep Alpha once weekly | Experimental |
| |
| Placebo once weekly | Placebo Comparator |
| |
| Taldefgrobep Alpha once every 4 weeks | Experimental |
| |
| Placebo once every 4 weeks | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taldefgrobep Alfa | Drug | Subcutaneous injection administered once each week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in total body weight from Baseline to Week 24 | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in total body fat mass from Baseline to Week 24 | Baseline to Week 24 | |
| Percent change in total body lean mass from Baseline to Week 24 | Baseline to Week 24 | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site-001 | Chula Vista | California | 91911 | United States | ||
| Site-014 |
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| Placebo | Drug | Subcutaneous injection (matching placebo) administered once each week |
|
| Taldefgrobep Alfa | Drug | Subcutaneous injection administered once every 4 weeks |
|
|
| Placebo | Drug | Subcutaneous injection (matching placebo) administered once every 4 weeks |
|
| Number of participants with death, SAEs, AEs considered related to study drug, moderate and severe AEs, and Grade 3 to 4 laboratory abnormalities |
| Through week 24 |
| Montclair |
| California |
| 97163 |
| United States |
| Site-011 | Sacramento | California | 95821 | United States |
| Site-018 | Tustin | California | 92780 | United States |
| Site-020 | Orlando | Florida | 32804 | United States |
| Site-008 | Palm Springs | Florida | 33461 | United States |
| Site-015 | St. Petersburg | Florida | 33704 | United States |
| Site-007 | Chicago | Illinois | 60625 | United States |
| Site-016 | Indianapolis | Indiana | 46254 | United States |
| Site-010 | Baton Rouge | Louisiana | 70808 | United States |
| Site-009 | Metairie | Louisiana | 70006 | United States |
| Site-006 | City of Saint Peters | Missouri | 63303 | United States |
| Site-003 | Springfield | Missouri | 65807 | United States |
| Site-019 | Monroe | North Carolina | 28112 | United States |
| Site-002 | Fargo | North Dakota | 58104 | United States |
| Site-017 | North Charleston | South Carolina | 29405 | United States |
| Site-005 | Austin | Texas | 78745 | United States |
| Site-012 | McKinney | Texas | 75069 | United States |
| Site-013 | San Antonio | Texas | 78229 | United States |
| Site-004 | Arlington | Virginia | 22205 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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