A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
Recruiting
Phase 3Interventional Study
ObesityWeight Gain
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for adolescents with obesity and related health issues. Participants will take tirzepatide and continue healthy eating and exercise over about 76 weeks.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesType 2 diabetesPancreatitisMedullary thyroid carcinomaMultiple endocrine neoplasia syndrome type 2
You may be able to join if
I have a body mass index (BMI) at or above the 95th percentile for my age and sex.
I have at least 2 weight-related health issues, like high blood pressure or prediabetes.
I have tried to lose weight before but have not been successful.
I can give consent through a legal representative or can agree to participate myself.
You may not be able to join if
I have had weight loss surgery or plan to have it during the study.
I have lost more than 5 kg (11 lbs) in the past 90 days.
I have type 1 diabetes or a history of serious diabetes-related issues.
I have type 2 diabetes with an HbA1c over 6.4% at screening.
I have a history of pancreatitis.
I or a family member have a history of certain thyroid cancers or related syndromes.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility 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.
* H…
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
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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