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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Subcutaneous injection administered once each week
Subcutaneous injection (matching placebo) administered once each week
Subcutaneous injection administered once every 4 weeks
Site-001
Chula Vista, California, United States
Site-014
Montclair, California, United States
Percent change in total body weight from Baseline to Week 24
Time frame: Baseline to Week 24
Percent change in total body fat mass from Baseline to Week 24
Time frame: Baseline to Week 24
Percent change in total body lean mass from Baseline to Week 24
Time frame: Baseline to Week 24
Number of participants with death, SAEs, AEs considered related to study drug, moderate and severe AEs, and Grade 3 to 4 laboratory abnormalities
Time frame: Through week 24
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Subcutaneous injection (matching placebo) administered once every 4 weeks
Site-011
Sacramento, California, United States
Site-018
Tustin, California, United States
Site-020
Orlando, Florida, United States
Site-008
Palm Springs, Florida, United States
Site-015
St. Petersburg, Florida, United States
Site-007
Chicago, Illinois, United States
Site-016
Indianapolis, Indiana, United States
Site-010
Baton Rouge, Louisiana, United States
...and 10 more locations