Obesity, Overweight
Conditions
Brief summary
The main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction.
Detailed description
All enrolled participants will complete a 60-week open-label Weight-Loss Period on tirzepatide maximum tolerated dose (MTD) and upon meeting randomization criteria will enter a 52-week double-blinded Weight Maintenance Period to be assigned to either tirzepatide 5 mg, tirzepatide MTD or placebo.
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)
Intervention model description
3b
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities: * Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease * Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (BW)
Exclusion criteria
* Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma. * Have a self-reported change in BW\>5 kilogram (kg) within 3 months prior to screening * Have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed \>1 year prior to screening. * Have a history of chronic or acute pancreatitis * Have any of the following cardiovascular conditions within 3 months prior to week 0. * Acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, and hospitalization due to congestive heart failure (CHF) * family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years * Any lifetime history of a suicide attempt
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period | Week 112 | Mean percent maintenance of BW reduction achieved during the 60-Week weight loss period will be measured in participants who have reached a BW plateau. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with an Assessment of (yes/no) of Maintaining ≥80% of the BW Reduction Achieved During the 60-week Weight-Loss Period | Week 112 | Assessment of (yes/no) of maintaining ≥80% of the BW reduction achieved during the 60-week weight loss period will be measured in participants who have reached a BW plateau. |
| Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization | Week 112 | Assessment of (yes/no) of maintaining ≥15% BW reduction for participants who have already lost ≥15% BW at randomization will be measured in participants who have reached a BW plateau. |
| Percent Change from Baseline in Body Weight | Baseline (Week 0), Week 112 | — |
| Change from Randomization in Body Weight | Week 60, Week 112 | — |
| Percent Change from Randomization in Body Weight | Week 60, Week 112 | — |
| Change from Randomization in Waist Circumference | Week 60, Week 112 | — |
| Percent Maintenance of BW Reduction Achieved During the 60-week Weight-Loss Period | Week 84 | — |
Countries
United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed