The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
905
Administered SC
Administered SC
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 40
Percentage of Time Continuous Glucose Monitor (CGM) Glucose Values are Between 70 and 180 milligrams per deciliter (mg/dL) (3.9 and 10.0 millimoles per liter (mmol/L) Inclusive, Per Day
Time frame: Within 30 days prior to Week 40
Change from Baseline in Body Weight
Time frame: Baseline, Week 40
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 40
Percentage of Participants with ≥5% Body Weight Reduction
Time frame: Baseline, Week 40
Percentage of Participants with ≥10% Body Weight Reduction
Time frame: Baseline, Week 40
Percentage of Participants with ≥15% Body Weight Reduction
Time frame: Baseline, Week 40
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 40
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 40
Percent Change from Baseline in Fasting Triglycerides
Time frame: Baseline, Week 40
Percent Change from Baseline in Fasting Non-High-Density Lipoprotein (non-HDL) Cholesterol
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Sansum Diabetes Research Institute
Santa Barbara, California, United States
Care Access - Santa Clarita
Santa Clarita, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Orita Clinical Research
Decatur, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
...and 136 more locations
Time frame: Baseline, Week 40
Percent Change from Baseline in Total Daily Insulin Dose
Time frame: Baseline, Week 40
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline, Week 40
Change from Baseline in EQ-5D-5L
Time frame: Baseline, Week 40