The main purpose of this study is to find out how well and how safely tirzepatide works long-term in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 20 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
465
Administered SC
Administered SC
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 40
Change from Baseline in HbA1c
Time frame: Baseline, Week 72
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, Within 30 days prior to Week 72
Change from Baseline in Body Weight
Time frame: Baseline, Week 40, Week 72
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 40, Week 72
Percentage of Participants with ≥5% Body Weight Reduction
Time frame: Baseline, Week 40, Week 72
Percentage of Participants with ≥10% Body Weight Reduction
Time frame: Baseline, Week 40, Week 72
Percentage of Participants with ≥15% Body Weight Reduction
Time frame: Baseline, Week 40, Week 72
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 40, Week 72
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 40, Week 72
Percent Change from Baseline in Fasting Triglycerides
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Kaiser Permanente Bonita Medical Offices
Bonita, California, United States
AMCR Institute
Escondido, California, United States
Mary & Dick Allen Diabetes Center
Newport Beach, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
HealthPartners Institute dba International Diabetes Center
Minneapolis, Minnesota, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Clinvest Headlands Llc
Springfield, Missouri, United States
...and 69 more locations
Time frame: Baseline, Week 40, Week 72
Percent Change from Baseline in Fasting Non-High-Density Lipoprotein (non-HDL) Cholesterol
Time frame: Baseline, Week 40, Week 72
Percent Change from Baseline in Total Daily Insulin Dose
Time frame: Baseline, Week 40, Week 72
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline, Week 40, Week 72
Change from Baseline in EQ-5D-5L
Time frame: Baseline, Week 40, Week 72