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Evaluating Tirzepatide for Adolescents with Obesity or Overweight

Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (SURMOUNT-ADOLESCENTS)

Phase 3 Interventional Eli Lilly and Company · NCT06075667

This study is testing if a weekly injection of tirzepatide can help teenagers who are overweight or obese and have health issues lose weight and improve their health compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment150 (estimated)
Ages12 Years to 17 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations33 sites (Decatur, Georgia and 32 other locations)
Trial IDNCT06075667 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of tirzepatide, administered once weekly, in adolescents who are classified as obese or overweight and have at least one related health issue. Over approximately 90 weeks, participants will attend up to 25 visits to monitor their progress and response to the treatment. The study will compare the effects of tirzepatide against a placebo to determine its impact on weight management and associated comorbidities.

Who should consider this trial

Good fit: Ideal candidates are adolescents with obesity or overweight, defined by specific BMI percentiles, who also have at least one weight-related comorbidity.

Not a fit: Patients who have experienced significant weight loss recently or those with Type 1 Diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve weight management and health outcomes for adolescents struggling with obesity and related conditions.

How similar studies have performed: Other studies have shown promising results with tirzepatide in adult populations, suggesting potential for success in this adolescent cohort.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR
* Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity.

  * dyslipidemia
  * pre-hypertension
  * hypertension
  * nonalcoholic fatty liver disease
  * obstructive sleep apnea
  * prediabetes
  * documented preexisting condition of Type 2 Diabetes

Participants with Type 2 Diabetes Mellitus (T2DM)

* Have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c\<9.0%

Exclusion Criteria:

* Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records.
* Have Type 1 Diabetes
* Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction.
* Are prepubertal (Tanner stage 1).
* Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2
* Have a history of chronic or acute pancreatitis.
* Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to

  * gastric bypass
  * sleeve gastrectomy
  * restrictive bariatric surgery, such as Lap-Band gastric banding, or
  * any other procedure intended to result in weight reduction.

Where this trial is running

Decatur, Georgia and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ObesityOverweight
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.