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Looking for participantsPhase3

A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)

Sponsor: Eli Lilly and Company

NCT ID: NCT06672549

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 28 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
Type of study
Testing a treatment
Ages
6 Years to 17 Years
Who
All
Number of participants
125
Started
2024-11-18
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for obesity
  • • Phase3 - 125 participants
  • • The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants

Who can take part?

  • • Ages 6 Years to 17 Years
  • • Diagnosed with obesity

Where?

  • • Barnsley - Barnsley Hospital NHS Foundation Trust
  • • Bristol - Bristol Royal Hospital for Children
  • • Cambridge - Addenbrookes Hospital
  • • Dundee - Ninewells Hospital
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.

More detail

The PWMP establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. PWMP results will be reported when all the ISA's complete.

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: 6 Years - 17 Years
  • Who can join: All genders

What the study is looking for

  • ✓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
  • ✓dyslipidemia

Who cannot take part

  • ✗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.
See the full criteria
Inclusion Criteria: * 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 * Applies to participant age between 12 and \<18 years old. 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: * 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 a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records * 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? (7 UK sites)

Barnsley Hospital NHS Foundation Trust

Barnsley S75 2EP, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Rajeev GuptaPrincipal Investigator

Bristol Royal Hospital for Children

Bristol BS2 8BJ, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Dinesh GiriPrincipal Investigator

Addenbrookes Hospital

Cambridge CB2 0QQ, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Ken OngPrincipal Investigator

Ninewells Hospital

Dundee DD1 9SY, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Nicholas ConwayPrincipal Investigator

Northwick Park Hospital

Harrow HA1 3UJ, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Nilanjana RayPrincipal Investigator

Hull Royal Infirmary - MAIN

Hull HU3 2JZ, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Sanjay GuptaPrincipal Investigator

Alder Hey Children's Hospital

Liverpool L14 5AB, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Senthil SenniappanPrincipal Investigator

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: 2026-10