The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.
The study will include a screening period of up to 5 weeks. The primary endpoint will be at Week 44 with a tirzepatide extension until week 80. A safety follow up will be performed approximately 4 weeks after end of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
414
Administered SC
Administered SC
Percent Change From Baseline in Body Weight
Time frame: Baseline (Week 0), Week 44
Change from Baseline in HbA1c
Time frame: Baseline (Week 0), Week 44
Change from Baseline in HbA1c
Time frame: Baseline (Week 24), Week 80
Percent Change from Baseline in Body Weight
Time frame: Baseline (Week 24), Week 80
Absolute Change from Baseline in Body Weight
Time frame: Baseline (Week 0), Week 44
Absolute Change from Baseline in Body Weight
Time frame: Baseline (Week 24), Week 80
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline (Week 0), Week 44
Change from Baseline in BMI
Time frame: Baseline (Week 24), Week 80
Change from Baseline in Waist Circumference
Time frame: Baseline (Week 0), Week 44
Change from Baseline in Waist Circumference
Time frame: Baseline (Week 24), Week 80
Percentage of Participants Achieving ≥15% Body Weight Reduction
Time frame: Baseline (Week 0), Week 44
Percentage of Participants Achieving ≥15% Body Weight Reduction
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Medical Advancement Centers of Arizona
Phoenix, Arizona, United States
John Muir Physician Network Research Center
Concord, California, United States
Care Access - Sacramento
Sacramento, California, United States
Care Access - Aurora
Aurora, Colorado, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Retreat Medical Research
Miami, Florida, United States
American Research Centers of Florida
Pembroke Pines, Florida, United States
Alta Pharmaceutical Research Center
Norcross, Georgia, United States
AGILE Clinical Research Trials, LLC
Sandy Springs, Georgia, United States
Northwestern University
Chicago, Illinois, United States
...and 30 more locations
Time frame: Baseline (Week 0), Week 80
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
Steady State Area Under the Concentration Time Curve (AUC) presented as a single average measure of AUC across the time frame.
Time frame: Baseline through Week 44