The main purpose of this study is to see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 36
Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)
Time frame: Baseline, Week 36
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 36
Percentage of Participants Achieving ≥5% Body Weight Reduction
Time frame: Baseline, Week 36
Percentage of Participants Achieving ≥10% Body Weight Reduction
Time frame: Baseline, Week 36
Percentage of Participants Achieving ≥15% Body Weight Reduction
Time frame: Baseline, Week 36
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 36
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 36
Change from Baseline in Waist-to-Height Ratio (WHtR)
Time frame: Baseline, Week 36
Percent Change from Baseline in Visceral Adipose Tissue (VAT) by Magnetic Resonance Imaging (MRI)
Time frame: Baseline, Week 36
Change from Baseline in Liver Fat by MRI
Time frame: Baseline, Week 36
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Administered SC
Yuma Clinical Trials
Yuma, Arizona, United States
Orange County Research Center
Lake Forest, California, United States
Healthy Brain Clinic
Long Beach, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Excel Medical Clinical Trials
Boca Raton, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States
L&C Professional Medical Research Institute
Miami, Florida, United States
Global Health Research Center, Inc.
Miami Lakes, Florida, United States
Charter Research - Winter Park
Orlando, Florida, United States
...and 40 more locations
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline, Week 36
Percent Change from Baseline in Total Cholesterol
Time frame: Baseline, Week 36
Percent Change from Baseline in Triglycerides (TG)
Time frame: Baseline, Week 36
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 36
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Bimagrumab
Time frame: Predose through Week 52