Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Tirzepatide for Obesity

The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to measure the how well it works, safety, and pharmacokinetics of tirzepatide as an addition to healthy lifestyle in participants 6 to less than 12 years of age, with obesity. Participation in the study will last about 104 weeks.

Official registry: https://clinicaltrials.gov/study/NCT07817875 · Eli Lilly and Company · enrollment listed as 150

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Tirzepatide, or Placebo. The registry lists allocation as randomized. The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to measure the how well it works, safety, and pharmacokinetics of tirzepatide as an addition to healthy lifestyle in participants 6 to less than 12 years of age, with obesity.

They plan to enroll about 150 people at 82 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial

Interventions: Tirzepatide, Placebo

Primary outcome (registry wording): Percent Change from Baseline in Body Mass Index (BMI)

Who it is for (from inclusion criteria)

  • Ages 6 Years to 11 Years
  • Are 6 to less than 12 years of age (Tanner stage 1 to 5 inclusive)
  • a body weight of ≥ 40 kilograms (kg) (88 pounds), and
  • been diagnosed with obesity, as defined by body-mass index (BMI) equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart
  • 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 body-mass index (BMI) equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \[CDC-NCHS, 2022\])

Public study contact (from the registry)

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

1-317-615-4559

LillyTrials@Lilly.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

82 listed

+ 41 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07817875 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07817875?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07817875?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary