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ObesityPhase 3NCT06672939

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

A Phase 3 study testing Orforglipron in people with Obesity and Overweight, run by Eli Lilly and Company at 34 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Obesity, Overweight
What is being tested?
Orforglipron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
34 sitesin 6 countries
Study dates
18 Nov 2024to Jan 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)
Show all 10Show fewer
  • prediabetes
  • dyslipidemia
  • obstructive sleep apnea
  • metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD)

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

34 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

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

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

34 sites in 6 countries

United States12 sites

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics

    Atlanta, Georgia, 30329

    Active, not recruiting

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

    Active, not recruiting

  • Dynamed Clinical Research, LP d/b/a DM Clinical Research

    Houston, Texas, 77065

    Active, not recruiting

  • La Providence Pediatrics Clinic - Chemidox Clinical Trials

    Houston, Texas, 77071-1008

    Active, not recruiting

  • Velocity Clinical Research

    Lafayette, Louisiana, 70508

    Active, not recruiting

  • Lucas Research, Inc.

    Morehead City, North Carolina, 28557

    Active, not recruiting

  • Vanderbilt Health One Hundred Oaks

    Nashville, Tennessee, 37212

    Active, not recruiting

  • Carey Chronis MD Pediatric, Infant and Adolescent Medicine

    Oxnard, California, 93030

    Active, not recruiting

  • Childrens Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

    Active, not recruiting

  • Sundance Clinical Research

    St Louis, Missouri, 63141-7068

    Active, not recruiting

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

    Active, not recruiting

  • Martin Diagnostic Clinic

    Tomball, Texas, 77375-3332

    Active, not recruiting

Other trials in United States

Japan9 sites, 9 recruiting

  • Saitama Medical University Hospital

    Iruma-Gun, 350-0495

    81120023812

    Toru Kikuchi

    Recruiting

  • Isesaki Municipal Hospital

    Isesaki-shi, 372-0817

    81120023812

    Yoko Takano

    Recruiting

  • University Hospital,Kyoto Prefectural University of Medicine

    Kawaramachidori, Kamigyo-ku, Kyoto-city, 602-8566

    81120023812

    Satoru Sugimoto

    Not yet recruiting

  • Tokyo Medical Center

    Meguro-Ku, 152-0021

    81120023812

    Masashi Miharu

    Recruiting

  • Shiga General Hospital

    Moriyama, 524-8524

    81120023812

    Katsuyuki Matsui

    Recruiting

  • Nara Prefecture General Medical Center

    Nara, 630-8054

    81120023812

    Sayaka Yoshida

    Recruiting

  • Osaka City General Hospital

    Osaka, 534-0021

    81120023812

    Jun Mori

    Recruiting

  • Sagaekiminami Clinic

    Saga, 840-0801

    81120023812

    Tateo Kuno

    Recruiting

  • Shikoku Medical Center for Children and Adults

    Zentsujichó, 765-8507

    81120023812

    Takafumi Okada

    Recruiting

Other trials in Japan

Poland4 sites

  • Krakowskie Centrum Medyczne - FutureMeds

    Krakow, 31-501

    Active, not recruiting

  • FutureMeds - Targowek

    Warsaw, 03-291

    Active, not recruiting

  • Instytut Diabetologii - Warsaw

    Warszewo, 2117

    Active, not recruiting

  • FutureMeds sp. z o. o.

    Wroclaw, 53-673

    Active, not recruiting

Other trials in Poland

Israel3 sites

  • Shamir Medical Center

    Beer Jacob, 73100

    Active, not recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9013102

    Active, not recruiting

  • Sheba Medical Center

    Ramat Gan, 52621

    Active, not recruiting

Other trials in Israel

Italy3 sites

  • Azienda Ospedaliero Universitaria Meyer

    Florence, 50139

    Active, not recruiting

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100

    Active, not recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

    Verona, 37126

    Active, not recruiting

Other trials in Italy

United Kingdom3 sites, 1 recruiting

  • Barnsley Hospital NHS Foundation Trust

    Barnsley, S75 2EP

    Active, not recruiting

  • Ninewells Hospital

    Dundee, DD1 9SY

    (44138) 238-8385

    Nicholas Conway

    Not yet recruiting

  • Hull Royal Infirmary

    Hull, HU3 2JZ

    Active, not recruiting

Other trials in United Kingdom

About this study

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)

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.

Conditions
Obesity, Overweight
Being tested
Orforglipron, Placebo
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrforglipronDrug

    Also called LY3502970

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT06672939
Study groupRoleWhat they receive
OrforglipronExperimentalParticipants will receive orforglipron orally
Receives: Drug: Orforglipron
PlaceboPlacebo comparatorParticipants will receive placebo orally
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change from Baseline in Body Mass Index (BMI)

    Measured: Baseline, Week 72

Secondary outcomes (12)

  1. Change from Baseline in BMI

    Measured: Baseline, Week 72

  2. Change from Baseline in Body Weight

    Measured: Baseline, Week 72

  3. Change from Baseline in Waist Circumference

    Measured: Baseline, Week 72

  4. Change from Baseline in Body Weight Percentile

    Based on sex- and age-specific growth charts

    Measured: Baseline, Week 72

  5. Change in Impact of Weight on Quality of Life (IWQOL)-Kids Total and Domain Scores

    The IWQOL-Kids is a validated, 27-item, patient reported outcomes instrument that assesses weight-related quality of life for youth aged 11 to 19 years in 4 domains:

    • physical comfort (6 items)
    • body esteem (9 items)
    • social life (6 items), and
    • family relations (6 items). It has a recall period of "the past 7 days." All items are rated on a 5-point truth scale ("always true" to "never true"). The 4-domain scores and total score range from 0 to 100, with higher scores indicating better quality of life.

    Measured: Baseline, Week 72

  6. Change from Baseline in Systolic Blood Pressure

    Measured: Baseline, Week 72

  7. Change from Baseline in Diastolic Blood Pressure

    Measured: Baseline, Week 72

  8. Percent Change from Baseline in Total Cholesterol

    Measured: Baseline, Week 72

  9. Change from Baseline in Fasting Glucose

    Measured: Baseline, Week 72

  10. Percent Change from Baseline in Fasting Insulin

    Measured: Baseline, Week 72

  11. Percent Change from Baseline in Total Body Fat Mass as Determined by Dual-Energy X-Ray Absorptiometry (DXA)

    Measured: Baseline, Week 72

  12. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Orforglipron

    Measured: Baseline, Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2024
  2. Study start18 Nov 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionJan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06672939
Sponsor's protocol ID
18868
Other IDs
J4M-MC-PW01, J4M-MC-PWMP Master Protocol, 2024-514081-40-00
Status last verified
Nov 2026
First submitted
1 Nov 2024
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Orforglipron in people with Obesity and Overweight, run by Eli Lilly and Company at 34 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Japan, Poland, Israel, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change from Baseline in Body Mass Index (BMI) (time frame: Baseline, Week 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06672939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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