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

Recruiting
12 - 17 years of age
Both
Phase 3

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Overview

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.

Eligibility

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.

Study details

Obesity, Overweight

NCT06075667

Eli Lilly and Company

3 May 2024

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