A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Orforglipron

    Drug

    Administered orally

  • Placebo

    Drug

    Administered orally

Treatment groups

2,001 Participants
are divided into 3 treatment groups
Group A: OrforglipronExperimental treatment 1 intervention
Group B: Orforglipron to PlaceboExperimental treatment 2 interventions
Group C: Placebo to OrforglipronExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline to Week 104

Secondary outcomes

1

Percent Change from Baseline in Body Weight

Time frame
Baseline, Week 104
2

Time to Onset of Waist-to-Height Ratio ≥0.6

Time frame
Baseline to Week 104
3

Change from Baseline in Waist Circumference

Time frame
Baseline, Week 104
4

Time to Onset of Class 1 Obesity

Time frame
Baseline to Week 104

Other outcomes

Sponsors and contacts

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