A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Individuals With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Eli Lilly and Company
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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-re…
Interventions
- DrugOrforglipron
Administered orally
- DrugPlacebo
Administered orally
Locations (180)
- Pinnacle Research Group, LLCAnniston, Alabama
- Central Research AssociatesBirmingham, Alabama
- Cahaba Research - PelhamPelham, Alabama
- Care Access - 801 South Power Road, MesaMesa, Arizona
- Absolute Clinical ResearchPhoenix, Arizona
- Synexus Clinical Research US, Inc./Orange Grove Family PracticeTucson, Arizona