Obesity Overweight
Conditions
Interventions
DRUG: Orforglipron(Other Name: LY3502970)
Administered orally
DRUG: Placebo
Administered orally
[Study Arms]
Experimental: Orforglipron
Participants will receive orforglipron orally
Intervent
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
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
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-BandR 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 72 | — |
Countries
Japan, United States
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed