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Looking for participantsPhase3

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

Sponsor: Eli Lilly and Company

NCT ID: NCT06672939

View on ClinicalTrials.gov ↗

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.

ObesityOverweight

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
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.

Where Is This Study? (3 UK sites)

Barnsley Hospital NHS Foundation Trust

Barnsley S75 2EP, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

RM&G Office

barnsley.research@nhs.net01226 432348

Ninewells Hospital

Dundee DD1 9SY, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Nicholas ConwayPrincipal Investigator

Hull Royal Infirmary

Hull HU3 2JZ, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

How to Get in Touch

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Sponsor contact

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

Sponsor contact

CONTACT

clinical_inquiry_hub@lilly.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08