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

Phase 3

Recruiting

• Conditions: Obesity; Weight Gain
• Interventions: Drug: Placebo; Drug: Tirzepatide

• Registration Number: NCT06439277
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity with multiple weight related comorbidities.

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-28
• Study Start: 2024-06-03
• Study First Posted: 2024-06-03
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-08
• Primary Completion: 2027-05
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo SC.
Tirzepatide	Tirzepatide	Participants will receive tirzepatide subcutaneously (SC).

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Mass Index (BMI)	Baseline, Week 72
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	Baseline, Week 72

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieve BMI Reduction of ≥ 5%	Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 10%	Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 15%	Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 20%	Week 72
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 72
Percent Change from Baseline in Triglycerides	Baseline, Week 72
Change from Baseline in Systolic Blood Pressure (SBP)	Baseline, Week 72
Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI)	Baseline, Week 72
Percent Change from Baseline in Total Body Fat Mass as Determined by Dual energy X-ray Absorptiometry (DXA)	Baseline, Week 72
Change from Baseline in Diastolic Blood Pressure (DBP)	Baseline, Week 72
Percent Change from Baseline in Body Weight	Baseline, Week 72
Change from Baseline in Waist Circumference	Baseline, Week 72

Trial Locations

Locations (72)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology; 🇺🇸 Sacramento, California, United States

Nemours Children's Health - Delaware; 🇺🇸 Wilmington, Delaware, United States

CenExel iResearch, LLC; 🇺🇸 Decatur, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Indiana University Health University Hospital; 🇺🇸 Indianapolis, Indiana, United States

UBMD Pediatrics; 🇺🇸 Buffalo, New York, United States

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States

Driscoll Children's Hospital; 🇺🇸 Corpus Christi, Texas, United States

Consano Clinical Research, LLC; 🇺🇸 Shavano Park, Texas, United States

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