Obesity, Overweight
Conditions
Keywords
Visceral adipose tissue, Energy intake
Brief summary
The main purpose of this study is to see how orforglipron affects the amount of body fat compared with placebo in participants with obesity or overweight. Participation in the study will last approximately 8 months.
Interventions
DRUGOrforglipron
Administered orally
DRUGPlacebo
Administered orally
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 a Body Mass Index (BMI) * ≥30.0 kilograms per square meter (kg/m2), or * ≥27.0 kg/m2 with comorbidities
Exclusion criteria
* Have type 1 diabetes, type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma * Have an unstable body weight within 90 days prior to screening * Have acute or chronic hepatitis * Are taking other medications or alternative remedies to manage weight loss
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Visceral Adipose Tissue (VAT) | Baseline, Week 36 |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Energy Intake | Baseline, Week 36 |
| Percent Change from Baseline in Appetite | Baseline, Week 36 |
| Percent Change from Baseline in Body Weight | Baseline, Week 36 |
| Percent Change from Baseline in Fasting Total Cholesterol | Baseline, Week 36 |
| Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP) | Baseline, Week 36 |
| Change from Baseline in International Physical Activity Questionnaire-Long Form (IPAQ-L) Scores | Baseline, Week 36 |
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