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Taking peoplePhase 3

Tirzepatide Tested in Teens With Obesity and Related Health Conditions

Tests tirzepatide with healthy eating and exercise in adolescents with obesity.

Plain-language title generated from the registry record
Registry title: A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

Key facts

Where
San Juan, Puerto RicoSee the site
Phase
Phase 3

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 12 and 17 years old?

Source: NCT06439277, who can take part

Where in Puerto Rico

  • University Pediatric HospitalSan Juan, Puerto RicoNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Eli Lilly and Company
Trial code
NCT06439277
Record updated
24 September 2026
Original description
The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits.Read full original descriptionShow less

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)

The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits.

Participants who have completed the primary 72-week GPIX study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

Inclusion: 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: 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 a history of chronic or acute pancreatitis; Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2; Have type 2 diabetes or have a HbA1c > 6.4% at screening.

ClinicalTrials.gov NCT06439277