About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Orforglipron
DrugAdministered orally
Placebo
DrugAdministered orally
Treatment groups
Trial outcomes
Primary outcomes
Time to Onset of Obesity Related Complications or Class 1 Obesity
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 outcomes
Percent Change from Baseline in Body Weight
Time to Onset of Waist-to-Height Ratio ≥0.6
Change from Baseline in Waist Circumference
Time to Onset of Class 1 Obesity
Sponsors and contacts
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