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New daily pill could help teens shed pounds in major trial

NCT ID NCT06672939

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 6 times

Summary

This study tests a once-daily pill called orforglipron to help teenagers with obesity or overweight lose weight. About 150 teens will take either the pill or a placebo for 18 months, along with lifestyle advice. The goal is to see if the pill safely reduces body mass index (BMI) and improves quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity Overweight

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60611, United States

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

    ACTIVE_NOT_RECRUITING

    Verona, 37126, Italy

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    ACTIVE_NOT_RECRUITING

    Novara, 28100, Italy

  • Azienda Ospedaliero Universitaria Meyer

    ACTIVE_NOT_RECRUITING

    Florence, 50139, Italy

  • Barnsley Hospital NHS Foundation Trust

    ACTIVE_NOT_RECRUITING

    Barnsley, S75 2EP, United Kingdom

  • Carey Chronis MD Pediatric, Infant and Adolescent Medicine

    ACTIVE_NOT_RECRUITING

    Oxnard, California, 93030, United States

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

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30329, United States

  • Childrens Hospital of Pittsburgh

    ACTIVE_NOT_RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

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

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77065, United States

  • FutureMeds - Targowek

    ACTIVE_NOT_RECRUITING

    Warsaw, 03-291, Poland

  • FutureMeds sp. z o. o.

    ACTIVE_NOT_RECRUITING

    Wroclaw, 53-673, Poland

  • Hull Royal Infirmary

    ACTIVE_NOT_RECRUITING

    Hull, HU3 2JZ, United Kingdom

  • Instytut Diabetologii - Warsaw

    ACTIVE_NOT_RECRUITING

    Warszewo, 2117, Poland

  • Isesaki Municipal Hospital

    RECRUITING

    Isesaki-shi, 372-0817, Japan

  • Krakowskie Centrum Medyczne - FutureMeds

    ACTIVE_NOT_RECRUITING

    Krakow, 31-501, Poland

  • La Providence Pediatrics Clinic - Chemidox Clinical Trials

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77071-1008, United States

  • Lucas Research, Inc.

    ACTIVE_NOT_RECRUITING

    Morehead City, North Carolina, 28557, United States

  • Martin Diagnostic Clinic

    ACTIVE_NOT_RECRUITING

    Tomball, Texas, 77375-3332, United States

  • Nara Prefecture General Medical Center

    RECRUITING

    Nara, 630-8054, Japan

  • Ninewells Hospital

    NOT_YET_RECRUITING

    Dundee, DD1 9SY, United Kingdom

  • Osaka City General Hospital

    RECRUITING

    Osaka, 534-0021, Japan

  • Sagaekiminami Clinic

    RECRUITING

    Saga, 840-0801, Japan

  • Saitama Medical University Hospital

    RECRUITING

    Iruma-Gun, 350-0495, Japan

  • Shaare Zedek Medical Center

    ACTIVE_NOT_RECRUITING

    Jerusalem, 9013102, Israel

  • Shamir Medical Center

    ACTIVE_NOT_RECRUITING

    Beer Jacob, 73100, Israel

  • Sheba Medical Center

    ACTIVE_NOT_RECRUITING

    Ramat Gan, 52621, Israel

  • Shiga General Hospital

    RECRUITING

    Moriyama, 524-8524, Japan

  • Shikoku Medical Center for Children and Adults

    RECRUITING

    Zentsujichó, 765-8507, Japan

  • Stamford Therapeutics Consortium

    ACTIVE_NOT_RECRUITING

    Stamford, Connecticut, 06905, United States

  • Sundance Clinical Research

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63141-7068, United States

  • Tokyo Medical Center

    RECRUITING

    Meguro-Ku, 152-0021, Japan

  • University Hospital,Kyoto Prefectural University of Medicine

    NOT_YET_RECRUITING

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

  • Vanderbilt Health One Hundred Oaks

    ACTIVE_NOT_RECRUITING

    Nashville, Tennessee, 37212, United States

  • Velocity Clinical Research

    ACTIVE_NOT_RECRUITING

    Lafayette, Louisiana, 70508, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.