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NCT Number: NCT06439277

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

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Placebo

Drug

Administered SC

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

  5. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 72

  6. Percent Change from Baseline in Triglycerides

    Time frame: Baseline, Week 72

  7. Change from Baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 72

  8. Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI)

    Time frame: Baseline, Week 72

  9. Percent Change from Baseline in Total Body Fat Mass as Determined by Dual energy X-ray Absorptiometry (DXA)

    Time frame: Baseline, Week 72

  10. Change from Baseline in Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Week 72

  11. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 72

  12. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 72

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2)

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Jun 3, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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