A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 18 Years to no upper limit; excludes diabetes; no BMI minimum stated; conditions: Overweight; Prediabetic State; Prehypertension; Obesity, Abdominal
- Interventions
- Orforglipron; Placebo
- Conditions
- Overweight; Prediabetic State; Prehypertension; Obesity, Abdominal
- Phase and size
- Phase 3 · 2001 participants
- Dates
- Start 2026-09
Primary completion 2029-08 - Sponsor
- Eli Lilly and Company (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Time to Onset of Obesity Related Complications or Class 1 ObesityBaseline to Week 104
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.