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Evaluating tirzepatide for treating obesity in adolescents

Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2)

Phase 3 Interventional Eli Lilly and Company · NCT06439277

This study is testing if tirzepatide can help teenagers with obesity lose weight and improve their heart health while they follow a healthy eating and exercise program.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment300 (estimated)
Ages12 Years to 17 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations73 sites (Los Angeles, California and 72 other locations)
Trial IDNCT06439277 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effects of tirzepatide on body weight and cardiovascular risk factors in adolescents with obesity and related health issues. Participants will receive either tirzepatide or a placebo while following a program that includes healthy nutrition and physical activity. The study will last approximately 76 weeks and may involve up to 23 visits to monitor progress and safety. The primary focus is on determining the safety and efficacy of tirzepatide in this population.

Who should consider this trial

Good fit: Ideal candidates are adolescents with a BMI at or above the 95th percentile for their age and sex, along with at least two weight-related comorbidities.

Not a fit: Patients who have undergone weight reduction procedures or have recently lost significant weight may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve weight management and reduce health risks in adolescents with obesity.

How similar studies have performed: Other studies have shown promising results with tirzepatide in adult populations, but this specific approach in adolescents is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia.
* Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.
* Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).

Exclusion Criteria:

* Have undergone or plan to undergo a 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.
* Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state
* Have type 2 diabetes or have a HbA1c \> 6.4% at screening
* Have a history of chronic or acute pancreatitis
* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

Where this trial is running

Los Angeles, California and 72 other locations

+23 more sites — see ClinicalTrials.gov for the full list.

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 ObesityWeight Gain
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.