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Taking peoplePhase 3

Tests orforglipron for weight management in children with obesity or overweight

Tests orforglipron against placebo in children aged 6 to 17 with obesity or overweight.

Key facts

Who runs it
Eli Lilly and Company
Where
Brasília, Caxias do Sul, and São Paulo, BrazilSee the 3 sitesAlso in 12 other countries, 113 sites
Trial code
Registry title
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Status
Recruiting
Phase
Phase 3
People taking part
125 people, planned
Started
18 Nov 2024
Expected to end
Mar 2027
Type of study
Interventional
Treatments tested
  • Orforglipron
  • Placebo
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with obesity, or with overweight and a weight-related health problem, who have already tried a lifestyle program without enough weight loss.

Age
6 to 17 years.
Sex
All sexes can join.
Disease stage
Obesity: BMI at or above the 95th percentile for age and sex. Overweight: BMI at or above the 85th but below the 95th percentile, plus at least 1 weight-related condition such as hypertension, type 2 diabetes, prediabetes, dyslipidemia, obstructive sleep apnea, MASH or MASLD.
Earlier treatment
At least 1 unsuccessful effort to lose weight after a structured lifestyle program (diet and exercise counseling for at least 3 months).

Main reasons for not taking part

  • Weight reduction surgery or procedure, done or planned during the study
  • A secondary cause of obesity, such as hypothalamic, monogenetic, syndromic or endocrine causes
  • Weight loss of more than 5 kg (11 lbs) in the 90 days before screening
  • Type 1 diabetes, or history of ketoacidosis or hyperosmolar state, or HbA1c above 9.0% (75 mmol/mol)
  • Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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)

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
  • 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 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 a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2
  • Have HbA1c >9.0% (75 mmol/mol) as measured by central laboratory at screening

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 17 years old?

Where in Brazil

Also in 12 other countries, 113 sites

  • L2IP - Instituto de Pesquisas ClínicasBrasília, BrazilContact: Eduardo Vasconcellos (principal investigator)Not yet recruiting
  • Hospital Universitario de Caxias do SulCaxias do Sul, BrazilContact: Marcia Inês Boff Rissotto (principal investigator)Not yet recruiting
  • CPQuali Pesquisa Clínica Sao PauloSão Paulo, BrazilContact: Francisco Samuel Magalhaes Lima (principal investigator)Not yet recruiting

About the trial

What the trial wants to find out

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.

The group in the trial

  • Orforglipron (ISA PW01)Treatment being tested

    Participants will receive orforglipron or placebo orally. Each ISA will detail the intervention specific.

    Treatment: Orforglipron and Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight
Plain-language title
Tests orforglipron for weight management in children with obesity or overweightGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06672549, who can take part
Record updated
4 November 2026