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A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

ConditionsObesityWeight Gain
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Tirzepatide

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: TirzepatideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change from Baseline in Body Mass Index (BMI)

Time frame
Baseline, Week 72
2

A Composite Endpoint of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at Screening Without Development of New Predefined Comorbidity or Worsening of Existing Predefined Comorbidity

Time frame
Baseline, Week 72

Secondary outcomes

1

Percentage of Participants Who Achieve BMI Reduction of ≥ 5%

Time frame
Week 72
2

Percentage of Participants Who Achieve BMI Reduction of ≥ 10%

Time frame
Week 72
3

Percentage of Participants Who Achieve BMI Reduction of ≥ 15%

Time frame
Week 72
4

Percentage of Participants Who Achieve BMI Reduction of ≥ 20%

Time frame
Week 72

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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