Obesity, Overweight, Type 1 Diabetes
Conditions
Brief summary
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.
Interventions
DRUGTirzepatide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have type 1 diabetes and on insulin treatment for at least one year prior to screening * Have an HbA1c value of 7.0% to 10.5% inclusive, at screening * Have a body mass index (BMI) of ≥25 kilograms per square meter (kg/m2) at screening * Are of stable weight for at least 90 days prior to screening and agree to not start an intensive diet or exercise program during the study
Exclusion criteria
* Have experienced two or more events requiring hospitalization due to poor glucose control (hyperglycemia or (diabetic ketoacidosis (DKA)) during the period of 180 days prior to screening and until randomization. * Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization. * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * Have had chronic or acute pancreatitis * Have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 40 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in HbA1c | 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 | Within 30 days prior to Week 40, Within 30 days prior to Week 72 |
| Change from Baseline in Body Weight | Baseline, Week 40, Week 72 |
| Percent Change from Baseline in Body Weight | Baseline, Week 40, Week 72 |
| Percentage of Participants with ≥5% Body Weight Reduction | Baseline, Week 40, Week 72 |
| Percentage of Participants with ≥10% Body Weight Reduction | Baseline, Week 40, Week 72 |
| Percentage of Participants with ≥15% Body Weight Reduction | Baseline, Week 40, Week 72 |
| Change from Baseline in Waist Circumference | Baseline, Week 40, Week 72 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 40, Week 72 |
| Percent Change from Baseline in Fasting Triglycerides | Baseline, Week 40, Week 72 |
| Percent Change from Baseline in Fasting Non-High-Density Lipoprotein (non-HDL) Cholesterol | Baseline, Week 40, Week 72 |
| Percent Change from Baseline in Total Daily Insulin Dose | Baseline, Week 40, Week 72 |
| Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) | Baseline, Week 40, Week 72 |
| Change from Baseline in EQ-5D-5L | Baseline, Week 40, Week 72 |
Countries
Argentina, Brazil, Canada, Czechia, France, Greece, Mexico, Romania, Spain, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed