A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-17
SponsorEli Lilly and Company
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tirzepatide
- Placebo
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov