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

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

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• Orforglipron (drug)
• Placebo (drug)

Sponsor: Eli Lilly and Company · Participants: 2,001 · Started: Aug 26, 2026

Contact the study team

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · Phone: 317-615-4559

Official record on ClinicalTrials.gov — NCT07794579

Locations in the U.S.

Conditions

• Overweight
• Prediabetes
• High Blood Pressure
• Abdominal Obesity

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.