Orforglipron in adults with overweight at risk for obesity-related problems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial evaluates the safety and efficacy of orforglipron versus placebo in adults with BMI 25–29.9 kg/m2 who have overweight-related risk factors such as prediabetes, prehypertension, or dyslipidemia. Participants must have tried weight loss measures before and meet specific waist-to-height ratio criteria. The study excludes people with diabetes, uncontrolled weight changes, or a history of obesity surgery. Sites are in Alabama, led by Eli Lilly with local research partners. The aim is to see if orforglipron reduces progression to obesity-related conditions and related risks.

Why it matters

Who can join: the full rules

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

Where it's running

• Pinnacle Research Group, LLC
  Anniston, Alabama, United States Recruiting
• Central Research Associates
  Birmingham, Alabama, United States Recruiting
• Cahaba Research - Pelham
  Pelham, Alabama, United States Recruiting
• Care Access - 801 South Power Road, Mesa
  Mesa, Arizona, United States Recruiting
• Synexus Clinical Research US, Inc./Orange Grove Family Practice
  Tucson, Arizona, United States Recruiting
• Orange County Research Center
  Lake Forest, California, United States Recruiting

+130 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.