A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
Recruiting
Phase 3Interventional Study
ObesityOverweight
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for teenagers who are overweight or have obesity with related health issues. Participants will take a daily medicine called orforglipron or a placebo for about 18 months and may continue receiving treatment afterward.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetes
You may be able to join if
I have tried to lose weight through diet and exercise before.
I have obesity defined by my BMI being at or above the 95th percentile for my age and sex.
I have overweight defined by my BMI being at or above the 85th percentile but below the 95th percentile for my age and sex and have at least one weight-related health issue.
You may not be able to join if
I am prepubertal.
I have lost more than 11 pounds in the last 90 days.
I have undergone or plan to undergo weight loss surgery.
I have a condition that is a secondary cause of obesity.
I have type 1 diabetes or a history of ketoacidosis.
My HbA1c is over 9.0%.
I have a family or personal history of medullary thyroid carcinoma.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), 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.
Participants who have completed the primary PW01 study (including …
The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), 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.
Participants who have completed the primary PW01 study (including the 4-week safety follow-up period) will have the opportunity to receive an additional 156 weeks of treatment with orforglipron as well as continuing the lifestyle intervention.
Trial Locations
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Eligibility 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 abov…
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.
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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