The main purpose of this study is to evaluate the efficacy and safety of Bimagrumab and Tirzepatide, alone or in combination, in adults with obesity or overweight, with at least one obesity related comorbidity, without Type 2 Diabetes. The study will last about 70 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Central Research Associates
Birmingham, Alabama, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 24
Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)
Time frame: Baseline, Week 24, Week 48
Change from Baseline in Body Weight
Time frame: Baseline, Week 24, Week 48
Percentage of Participants Achieving ≥5% Body Weight Reduction
Time frame: Baseline, Week 24, Week 48
Percentage of Participants Achieving ≥10% Body Weight Reduction
Time frame: Baseline, Week 24, Week 48
Percentage of Participants Achieving ≥15% Body Weight Reduction
Time frame: Baseline, Week 24, Week 48
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 24, Week 48
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 24, Week 48
Change from Baseline in Waist-to-Height Ratio (WHtR)
Time frame: Baseline, Week 24, Week 48
Percent Change from Baseline in Visceral Adipose Tissue (VAT)
Time frame: Baseline, Week 24, Week 48
Percent Change from Baseline in Total Body Lean Mass by DXA
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Administered SC
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States
Altus Research
Lake Worth, Florida, United States
Suncoast Research Group
Miami, Florida, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, United States
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, United States
...and 2 more locations
Time frame: Baseline, Week 24, Week 48