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Taking people in JapanPhase 3

Tests orforglipron pill against placebo in teens with obesity or overweight

Tests a once-daily oral orforglipron pill versus placebo in adolescents with obesity or overweight.

Key facts

Who runs it
Eli Lilly and Company
Where
Iruma-gun, Isesaki-shi, Kawaramachidori, Kamigyo-ku, Kyoto-city, Meguro-Ku, Moriyama, Nara, Osaka, Saga, and Zentsujichó, JapanSee the 9 sitesAlso in 5 other countries, 26 sites
Trial code
Registry title
A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
Status
Recruiting
Phase
Phase 3
People taking part
150 people, planned
Started
18 Nov 2024
Expected to end
Jan 2031
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
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 teenagers aged 12 to 17 with obesity, or with overweight and at least 1 weight-related health problem. They must have tried to lose weight with a lifestyle program before.

Age
12 to 17 years
Sex
All sexes can join.
Disease stage
Obesity (BMI at or above the 95th percentile for age and sex), or overweight (BMI at or above the 85th but below the 95th percentile) with at least 1 weight-related condition. These include high blood pressure, type 2 diabetes, prediabetes, abnormal blood fats, sleep apnea, or fatty liver disease (MASH or MASLD).
Earlier treatment
At least 1 unsuccessful try at losing weight after a structured lifestyle program (diet and exercise counseling for at least 3 months).

Main reasons for not taking part

  • Has not yet started puberty (Tanner stage 1)
  • Lost more than 5 kg (11 pounds) of body weight in the 90 days before screening
  • Has had or plans weight loss surgery or a similar weight reduction procedure
  • Has type 1 diabetes, or HbA1c above 9.0% (75 mmol/mol)
  • Has a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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 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
  • J4M-MC-PW01
  • Prepubertal (Tanner stage 1)

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 12 and 17 years old?

Where in Japan

Also in 5 other countries, 26 sites

  • Saitama Medical University HospitalIruma-gun, JapanContact: Toru Kikuchi (principal investigator)Taking people
  • Isesaki Municipal HospitalIsesaki-shi, JapanContact: Yoko Takano (principal investigator)Taking people
  • University Hospital,Kyoto Prefectural University of MedicineKawaramachidori, Kamigyo-ku, Kyoto-city, JapanContact: Satoru Sugimoto (principal investigator)Not yet recruiting
  • Tokyo Medical CenterMeguro-Ku, JapanContact: Masashi Miharu (principal investigator)Taking people
  • Shiga General HospitalMoriyama, JapanContact: Katsuyuki Matsui (principal investigator)Taking people
  • Nara Prefecture General Medical CenterNara, JapanContact: Sayaka Yoshida (principal investigator)Taking people
  • Osaka City General HospitalOsaka, JapanContact: Jun Mori (principal investigator)Taking people
  • Sagaekiminami ClinicSaga, JapanContact: Tateo Kuno (principal investigator)Taking people
  • Shikoku Medical Center for Children and AdultsZentsujichó, JapanContact: Takafumi Okada (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • OrforglipronTreatment being tested

    Participants will receive orforglipron orally

  • PlaceboPlacebo, for comparison

    Participants will receive placebo orally

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 and on the EU's official list of trials (CTIS).
Official title
Efficacy, Safety, and Pharmacokinetics of Orforglipron Once Daily Oral Versus Placebo in Adolescent Participants Who Have Obesity, or Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (ADVANCE-ATTAIN-ADOLESCENTS)
Plain-language title
Tests orforglipron pill against placebo in teens 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 NCT06672939, who can take part
Record updated
4 November 2026