Obesity
Conditions
Keywords
Overweight, Electronic health records, Primary care, Type 2 diabetes incidence, Obesity related complications, Pragmatic trial, Randomized trial
Brief summary
The purpose of this study is to evaluate tirzepatide within a real-world setting to assess body weight loss and incidence of type 2 diabetes in adults without diabetes who have obesity and at least one weight-related comorbid condition. Eligible participants must be registered patients at a participating site. Participation in the study will last about 260 weeks.
Interventions
DRUGTirzepatide
Administered SC
OTHERStandard of Care
Standard of care
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a body mass index ≥30 and ≤34.9 kilogram per square meter (kg/m2) * Have an increased waist to height ratio (defined by \>0.5) * Have at least one weight related comorbid condition * Have had at least one attempt to lose weight with lifestyle intervention (diet and physical activity)
Exclusion criteria
* Have type 1 diabetes, type 2 diabetes, or any other types of diabetes * Have had a change in body weight of greater than 5 kilograms (11 pounds) within 90 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight | Baseline, 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Time from Baseline to Onset of Type 2 Diabetes | Baseline through 60 months |
| Percentage of Participants Converting from Prediabetes to Normoglycemia | 60 months |
| Percentage of Participants with Normoglycemia at Baseline who Develop Prediabetes | 60 months |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, 60 months |
| Percentage of Participants who Develop a New Obesity-Related Complication | 60 months |
| Change from Baseline in Waist Circumference | Baseline, 60 months |
| Change from Baseline in Waist-to-Height Ratio | Baseline, 60 months |
| Change from Baseline in Total Cholesterol | Baseline, 60 months |
| Change from Baseline in Systolic Blood Pressure | Baseline, 60 months |
| Change from Baseline in Diastolic Blood Pressure | Baseline, 60 months |
| Percent Change from Baseline Urinary Albumin-to-Creatinine Ratio (UACR) | Baseline, 60 months |
| Change from Baseline in EQ-5D-5L | Baseline, 60 months |
| Change from Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials (IWQOL-lite-CT) | Baseline, 60 months |
| Change from Baseline in Healthcare Resource Utilization (HCRU) | Baseline, 60 months |
| Change from Baseline in Alanine Aminotransferase (ALT) | Baseline, 60 months |
| Change from Baseline in Aspartate Aminotransferase (AST) | Baseline, 60 months |
Countries
United Kingdom
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
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