Obesity, Abdominal, Overweight, Prediabetic State, Prehypertension
Conditions
Keywords
Predyslipidemia, Weight management, Cardiovascular risk factors, Obesity prevention, Lower BMI, Early intervention in people with obesity
Brief summary
This study will evaluate the efficacy and safety of orforglipron in participants with overweight and assess whether it helps reduce the future risk of obesity-related conditions, including type 2 diabetes, hypertension, and dyslipidemia, and progression to class 1 obesity.
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 an increased waist-to-height ratio of ≥0.5 * Have at least one pre-obesity-related complication (prediabetes, prehypertension, predyslipidemia) * Have at least one unsuccessful attempt to reduce body weight based on diet and exercise * Have a BMI greater than or equal to 25 to less than or equal to 29.9 kg/m2 or equivalent-/region-specific overweight thresholds
Exclusion criteria
* Have type 1 diabetes, type 2 diabetes, or any other type of diabetes * Do not have a stable body weight within 90 days before screening * Have a documented obesity diagnosis or self-reported history of BMI ≥30 kg/m² (or an equivalent region-specific threshold) * Have taken medications for weight loss, including over-the counter medications or alternative therapies, within 180 days prior to screening * Have a prior or planned surgical treatment or procedure for obesity * Have hypertension or history of hypertension * Have dyslipidemia or history of dyslipidemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Onset of Obesity Related Complications or Class 1 Obesity | Baseline to Week 104 | Obesity related complications defined as type 2 diabetes, hypertension, or dyslipidemia; Class 1 obesity defined as body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or an equivalent region-specific threshold |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 104 |
| Time to Onset of Waist-to-Height Ratio ≥0.6 | Baseline to Week 104 |
| Change from Baseline in Waist Circumference | Baseline, Week 104 |
| Time to Onset of Class 1 Obesity | Baseline to Week 104 |
| Time to First Occurrence of Composite Endpoint of Type 2 Diabetes, Hypertension, Dyslipidemia | Baseline to Week 104 |
| Time to Onset of Type 2 Diabetes | Baseline to Week 104 |
| Percent Change from Baseline in Total Fat Mass | Baseline, Week 104 |
| Change from Baseline in Systolic Blood Pressure | Baseline, Week 104 |
| Change from Baseline in Glycated Hemoglobin (HbA1c) | Baseline, Week 104 |
| Percent Change from Baseline in Triglycerides | Baseline, Week 104 |
| Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Score | Baseline, Week 104 |
| Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron | Week 4, 12, 24, 52, and 76 |
Countries
Argentina, China, Czechia, Germany, India, Japan, Mexico, Puerto Rico, South Korea, Spain, Taiwan, United States
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