Orforglipron for Obesity and Overweight in Teens

A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities

Recruiting Phase 3 Interventional Study
Obesity Overweight
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
12 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for

This trial is looking for teenagers who are overweight or have obesity with related health issues. Participants will take a daily medicine called orforglipron or a placebo for about 18 months and may continue receiving treatment afterward.

Are You a Good Fit for This Trial?
Rules you out Type 1 diabetes

You may be able to join if

  • I have tried to lose weight through diet and exercise before.
  • I have obesity defined by my BMI being at or above the 95th percentile for my age and sex.
  • I have overweight defined by my BMI being at or above the 85th percentile but below the 95th percentile for my age and sex and have at least one weight-related health issue.

You may not be able to join if

  • I am prepubertal.
  • I have lost more than 11 pounds in the last 90 days.
  • I have undergone or plan to undergo weight loss surgery.
  • I have a condition that is a secondary cause of obesity.
  • I have type 1 diabetes or a history of ketoacidosis.
  • My HbA1c is over 9.0%.
  • I have a family or personal history of medullary thyroid carcinoma.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Answer a few quick questions to see if you may meet the eligibility requirements.

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About This Trial
The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of orforglipron once daily oral versus Placebo in adolescent participants with obesity, or overweight with related comorbidities. Participation in the study will last about 18 months. Participants who have completed the primary PW01 study (including …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: J4M-MC-PWMP * Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening. * Obesity as defined by BMI equal to or abov…
Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

LillyTrials@Lilly.com

CONTACT

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

CONTACT