A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities

Phase 3

Not yet recruiting

Brief Summary: The main purpose of this study, performed under Master Protocol J4M-MC-PWMP, is to evaluate the efficacy, safety, and pharmacokinetics of orforglipron once daily oral versus Placebo in adolescent participants with obesity, or overweight with related comorbidities. Participation in the study will last about 18 months.

Recruitment & Eligibility

Inclusion Criteria

J4M-MC-PWMP

Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening.
Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart [CDC-NCHS, 2022]); OR
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 (CDC-NCHS, 2022), and at least 1 weight-related comorbidity,
- hypertension
- type 2 diabetes (T2D)
- prediabetes
- dyslipidemia
- obstructive sleep apnea
- metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD)

Exclusion Criteria

J4M-MC-PW01

Prepubertal (Tanner stage 1)
Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening

J4M-MC-PWMP

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.
Have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes.
Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state.
Have HbA1c >9.0% (75 mmol/mol) as measured by central laboratory at screening.
Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.

Arm && Interventions

Group	Intervention	Description
Orforglipron	Orforglipron	Participants will receive orforglipron orally
Placebo	Placebo	Participants will receive placebo orally

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in BMI	Baseline, Week 72
Change from Baseline in Body Weight	Baseline, Week 72
Change from Baseline in Waist Circumference	Baseline, Week 72
Change from Baseline in Body Weight Percentile	Baseline, Week 72	Based on sex- and age-specific growth charts
Change in Impact of Weight on Quality of Life (IWQOL)-Kids Total and Domain Scores	Baseline, Week 72	The IWQOL-Kids is a validated, 27-item, patient reported outcomes instrument that assesses weight-related quality of life for youth aged 11 to 19 years in 4 domains: * physical comfort (6 items) * body esteem (9 items) * social life (6 items), and ...
Change from Baseline in Systolic Blood Pressure	Baseline, Week 72
Change from Baseline in Diastolic Blood Pressure	Baseline, Week 72
Percent Change from Baseline in Total Cholesterol	Baseline, Week 72
Change from Baseline in Fasting Glucose	Baseline, Week 72
Percent Change from Baseline in Fasting Insulin	Baseline, Week 72
Percent Change from Baseline in Total Body Fat Mass as Determined by Dual-Energy X-Ray Absorptiometry (DXA)	Baseline, Week 72
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Orforglipron	Baseline, Week 72

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