Join a Trial Testing Tirzepatide in Adolescents
If you are living with obesity or overweight and are 12 to 17 years of age, you may be eligible to join a trial studying the impact of tirzepatide on weight management.
Clinical Trials Identifier: NCT06075667
Trial Name: A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS)
Trial Sponsor: Eli Lilly and Company
What is the aim of the study?
This study will evaluate how effective and safe tirzepatide is for weight management in adolescents who have obesity or are overweight with related conditions when compared to a fake study drug.
Tirzepatide is FDA approved for type 2 diabetes management under the label Mounjaro as well as for chronic weight management under the name Zepbound for adults with obesity or overweight.
The safety and efficacy of tirzepatide have not been established in pediatric patients, however, and tirzepatide is not currently approved for use in patients younger than 18 years. If the data from this clinical trial is able to demonstrate that tirzepatide is safe and effective for weight management in teens, then the medication may also receive FDA approval for use among a younger population.
How does the trial work?
For this study, researchers will observe approximately 150 participants who are 12 to 17 years of age who either have obesity (a body mass index, or BMI, equal to or above the 95th percentile) or participants between 12 and 17 who are overweight (a BMI between the 85th and 94th percentile) with at least one weight-related comorbidity.
Participants will be randomly selected to receive either injectable tirzepatide or a placebo. Researchers will be observing various outcome measures throughout the process, including percent change from baseline in BMI, body weight, waist circumference, blood pressure, cholesterol, and fasting blood glucose, among other measurements. The study will last approximately 90 weeks (about 22 months) and may include up to 25 clinic visits.
Are you interested in participating?
You may be eligible if you:
- Are anywhere from 12 to 17 years of age
- Either:
- Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex; or
- Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, and at least one weight-related comorbidity (such as dyslipidemia, pre-hypertension, hypertension, MASLD, obstructive sleep apnea, prediabetes, or documented pre-existing condition of type 2 diabetes).
- Participants with pre-existing type 2 diabetes must have an A1C of less than 9.0% and have been treated with either lifestyle changes alone or metformin for at least 90 days prior to screening.
Those who have received a diagnosis of type 1 diabetes, experienced a decrease in weight of more than 11 pounds 90 days before screening, have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2, have taken or intend to start taking weight loss supplements, prescriptions, or over-the-counter medications within 90 days before screening, are Tanner stage 1 prepubertal, have a history of chronic or acute pancreatitis, or have undergone/plan to undergo weight reduction procedures are not eligible to participate. See a full list of inclusion and exclusion criteria here.
This study is currently recruiting in Georgia, Idaho, Kansas, Louisiana, Maryland, Minnesota, Missouri, Ohio, and Tennessee, as well as Alberta, Ontario, and Quebec provinces in Canada, Czechia, Israel, Italy, Mexico, and Poland. To enroll or learn more about this study, contact the Lilly clinical trials team at [email protected] or the phone number 1-877-CTLILLY (1-877-285-4559).
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