Clinical trial

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

Active, not recruiting · Phase 3 · 6 countries · Registry ID NCT06075667

Active, not recruitingPhase 3Interventional

What this study is 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. 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 17 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Overweight

Full registry criteria

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.

Treatments and study arms

Tirzepatide

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

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

Study locations

33 locations were listed when this page was built. The first 40 are shown.

CIUSSS- saguenay-Lac-Saint-Jean🇨🇦 Chicoutimi, Quebec, Canada