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Aventiv Research | Aventiv Research Columbus

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

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Lilly

Status and phase

Enrolling
Phase 3

Conditions

Overweight
Obesity

Treatments

Drug: Placebo
Drug: Tirzepatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT06075667
2023-504413-80-00 (Other Identifier)
I8F-MC-GPHP (Other Identifier)
17365

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 2 patient groups, including a placebo group

Tirzepatide
Experimental group
Description:
Participants will receive tirzepatide subcutaneously (SC).
Treatment:
Drug: Tirzepatide
Placebo
Placebo Comparator group
Description:
Participants will receive placebo.
Treatment:
Drug: Placebo

Trial contacts and locations

38

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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