At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Orforglipron (drug), Placebo (drug)
- How long the study runs
- Study runs about 74 months (dates as stated)
- About the drug or intervention
- Orforglipron — drug: Administered orally · Placebo — drug: Administered orally
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Eli Lilly and Company, is testing a medicine called orforglipron (also known as LY3502970) in teenagers with obesity, or who are overweight with a weight-related health problem. Participants must have already tried to lose weight through a structured diet and exercise programme lasting at least 3 months without success.
Who can take part
- Obesity, meaning a body mass index (BMI) at or above the 95th percentile for their age and sex, OR overweight (BMI at or above the 85th but below the 95th percentile) with at least one weight-related condition such as high blood pressure, type 2 diabetes, prediabetes, abnormal blood fats (dyslipidemia), obstructive sleep apnea, or a fatty liver condition (MASH or MASLD)
- Have tried to lose weight before through a diet and exercise programme lasting at least 3 months, without losing enough weight
Who may not be able to
- Have not yet started puberty (Tanner stage 1)
- Have lost more than 5 kg (11 pounds) in the 90 days before screening, reported by themselves, a parent, or a legal guardian
- Have had or plan to have weight-loss surgery during the study, such as gastric bypass, sleeve gastrectomy, or gastric banding
- Have obesity caused by another condition, such as a problem with the hypothalamus, a genetic cause, a syndrome, or a hormone (endocrine) problem
- Have type 1 diabetes, or a history of ketoacidosis or a hyperosmolar state
- Have an HbA1c (a blood sugar measure) above 9.0% (75 mmol/mol) at screening
- They or a family member have had medullary thyroid carcinoma (a rare thyroid cancer) or Multiple Endocrine Neoplasia Syndrome Type 2
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 12 Years to 17 Years
- Who
- All
- Number of participants
- 150
- Started
- 2024-11-18
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for obesity
- • Phase3 - 150 participants
- • 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
Who can take part?
- • Ages 12 Years to 17 Years
- • Diagnosed with obesity
Where?
- • Barnsley - Barnsley Hospital NHS Foundation Trust
- • Dundee - Ninewells Hospital
- • Hull - Hull Royal Infirmary
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 12 Years - 17 Years
- Who can join: All genders
What the study is looking for
- ✓J4M-MC-PWMP
- ✓Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth...
- ✓hypertension
- ✓type 2 diabetes (T2D)
- ✓prediabetes
Who cannot take part
- ✗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...
- ✗J4M-MC-PWMP
- ✗Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to:
See the full criteria
Where Is This Study? (3 UK sites)
Barnsley Hospital NHS Foundation Trust
Barnsley S75 2EP, United Kingdom
Ninewells Hospital
Dundee DD1 9SY, United Kingdom
Hull Royal Infirmary
Hull HU3 2JZ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903How to Get in Touch
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Sponsor contactCONTACT
Physicians interested in becoming principal investigators please contact
Sponsor contactCONTACT
