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NCT Number: NCT06075667

A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits.

Participants who have completed the primary 72-week GPHP 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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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alberta Diabetes Institute, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR
  • Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity.
  • dyslipidemia
  • pre-hypertension
  • hypertension
  • nonalcoholic fatty liver disease
  • obstructive sleep apnea
  • prediabetes
  • documented preexisting condition of Type 2 Diabetes

Participants with Type 2 Diabetes Mellitus (T2DM)

  • Have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c<9.0%

Exclusion criteria

  • Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records.
  • Have Type 1 Diabetes
  • Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction.
  • Are prepubertal (Tanner stage 1).
  • Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2
  • Have a history of chronic or acute pancreatitis.
  • Have undergone or plan to undergo 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.

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

Secondary outcomes

  1. Percentage of Participants with ≥5% BMI Reduction

    Time frame: Baseline, Week 72

  2. Change from Baseline in Body Weight

    Time frame: Baseline, Week 72

  3. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 72

  4. Change in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score

    Time frame: Baseline, Week 72

  5. Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts

    Time frame: Baseline, Week 72

  6. Change from Baseline in Systolic Blood Pressure

    Time frame: Baseline, Week 72

  7. Change from Baseline in Diastolic Blood Pressure

    Time frame: Baseline, Week 72

  8. Percent Change from Baseline in Total Cholesterol

    Time frame: Baseline, Week 72

  9. Change from Baseline in Fasting Glucose

    Time frame: Baseline, Week 72

  10. Change from Baseline in Fasting Insulin

    Time frame: Baseline, Week 72

  11. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide

    Time frame: Baseline through Week 72

    AUC is presented as a single average measure of AUC across the study duration.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (SURMOUNT-ADOLESCENTS)

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Oct 10, 2023
Registry last updated
Jun 29, 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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